Developing an Activity Pacing Framework: Feasibility and Acceptability

• Sponsor: Pennine Acute Hospitals NHS Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT03497585
• Collaborator: University of Leeds (Other), National Institute for Health Research, United Kingdom (Other)
• Enrollment: 112
• Location: 1
• Actual Duration (Months): 19.4
• Patients Per Site Per Month: 5.8

Study Details

Study Description

Brief Summary

This study explores whether it is feasible to use a newly developed activity pacing framework to standardise how activity pacing is instructed by healthcare professionals in rehabilitation programmes for patients with chronic pain/fatigue.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain; Fibromyalgia; Chronic Fatigue Syndrome; Chronic Low Back Pain	Behavioral: Activity pacing framework

Detailed Description

Activity pacing is frequently advised in the management of chronic pain/fatigue, including chronic low back pain, chronic widespread pain/fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis. However, there is no agreed definition of 'activity pacing' and it is instructed in various ways. For some, pacing involves adapting/limiting activities (for example, breaking down tasks/having rests); while for others, pacing involves having consistent activities/gradually increasing activities. Furthermore, pacing has been associated with both improved symptoms (decreased fatigue/anxiety/depression) and worsened symptoms (increased pain/disability).

Due to the high prevalence and cost (personal and financial) of chronic pain/fatigue, it is imperative that coping strategies such as pacing are clearly defined and evidence-based. This study involves Stage III in the development of an activity pacing framework to standardise how pacing is instructed by healthcare professionals. Stage I: Online Survey of pacing involved 92 healthcare professionals (doctors/nurses/physiotherapists/occupational therapists/clinical psychologists). The survey findings, together with existing research were used to develop the pacing framework. The framework was further developed in Stage II: Nominal Group Technique (consensus meeting), involving four patients and six healthcare professionals.

Stage III will test the feasibility of implementing the pacing framework clinically, by using it to underpin existing rehabilitation programmes for chronic pain/fatigue. Patients will attend rehabilitation programmes at the study sites as per usual practice. Patients' participation in this study involves their completion of a booklet of questionnaires. The aim of this feasibility study is to explore whether the activity pacing framework is usable in the clinical setting, to explore recruitment/retention rates, together with changes in symptoms between the start and end of treatment, and at 3-months follow-up. Stage III will also explore the acceptability of the framework by undertaking interviews with the patients and healthcare professionals involved in the rehabilitation programmes. Stage III is expected to last 22 months.

Future study will test the framework in a clinical trial to assess the effects of pacing on patients' symptoms. The pacing framework has the potential to improve treatments by providing guidance on the components of pacing found to have benefits for patients.

This study is funded by a Health Education England/National Institute for Health Research (HEE/NIHR) Integrated Clinical Academic (ICA) Clinical Lectureship.

Study Design

• Study Type: Observational
• Actual Enrollment: 112 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Developing an Activity Pacing Framework for the Management of Chronic Pain/Fatigue. Stage III: Feasibility and Acceptability Studies
• Actual Study Start Date: May 21, 2018
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm

Intervention/Treatment

Activity Pacing Framework Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.

Behavioral: Activity pacing framework; The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.

Outcome Measures

Primary Outcome Measures

1. Change in Activity Pacing Questionnaire (APQ-28) From Baseline to the End of the 6-week's Programme [Change in activity pacing from baseline (pre-treatment: up to one week before the programme) to the end of the 6-week's programme]

   The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to assess the changes in activity pacing from baseline (pre-treatment: up to one week before the programme) to end of the programme (6-week's programme). Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.

Secondary Outcome Measures

1. Activity Pacing at Baseline: Activity Pacing Questionnaire (APQ-28) [Baseline (pre-treatment: up to one week before the programme)]

   The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to measure activity pacing at baseline (pre-treatment: up to one week before the programme). Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.

2. Activity Pacing at the End of Treatment: Activity Pacing Questionnaire (APQ-28) [6-weeks (end of the programme)]

   The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to measure activity pacing at the end of the 6-week's programme. Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.

3. Activity Pacing at 3-months Follow up: Activity Pacing Questionnaire (APQ-28) [3-months follow-up (after the end of the 6-week's programme)]

   The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to measure activity pacing at 3-months follow up after the end of the 6-week's programme. Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.

4. Pain at Baseline: 11-point Numerical Rating Scale (NRS) of Pain [Baseline (pre-treatment: up to one week before the programme)]

   Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at baseline (pre-treatment: up to one week before the programme)

5. Pain at the End of Treatment (6-weeks): 11-point Numerical Rating Scale (NRS) of Pain [6-weeks (end of the programme)]

   Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at the end of the 6-week's programme.

6. Pain at 3-months Follow up: 11-point Numerical Rating Scale (NRS) of Pain [3-months follow-up (after the end of the 6-week's programme)]

   Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at 3-months follow up after the end of the 6-week's programme

7. Depression at Baseline: Patient Health Questionnaire-9 (PHQ-9) [Baseline (pre-treatment: up to one week before the programme)]

   The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression.

8. Depression at the End of Treatment (6-weeks): Patient Health Questionnaire-9 (PHQ-9) [6-weeks (end of the programme)]

   The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at the end of the 6-week's programme. The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression.

9. Depression at 3-months Follow-up: Patient Health Questionnaire-9 [3-months follow-up (after the end of the 6-week's programme)]

   The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression.

10. Anxiety at Baseline: Generalised Anxiety Disorder Assessment (GAD-7) [Baseline (pre-treatment: up to one week before the programme)]

    The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety.

11. Anxiety at the End of Treatment (6-weeks): Generalised Anxiety Disorder Assessment (GAD-7) [6-weeks (end of the programme)]

    The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at the end of the 6-week's programme. The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety.

12. Anxiety at 3-months Follow up: Generalised Anxiety Disorder Assessment (GAD-7) [3-months follow-up (after the end of the 6-week's programme)]

    The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety.

13. Self-efficacy at Baseline: Pain Self Efficacy Questionnaire (PSEQ) [Baseline (pre-treatment: up to one week before the programme)]

    The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at baseline (pre-treatment: up to one week before the programme). The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low.

14. Self-efficacy at the End of Treatment: Pain Self Efficacy Questionnaire (PSEQ) [6-weeks (end of the programme)]

    The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at the end of the 6-week's programme. The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low.

15. Self-efficacy at 3-months Follow up: Pain Self Efficacy Questionnaire (PSEQ) [3-months follow-up (after the end of the 6-week's programme)]

    The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at 3-months follow up after the end of the 6-week's programme. The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low.

16. Fatigue at Baseline: Chalder Fatigue Questionnaire (CFQ) [Baseline (pre-treatment: up to one week before the programme)]

    The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue.

17. Fatigue at the End of Treatment: Chalder Fatigue Questionnaire (CFQ) [6-weeks (end of the programme)]

    The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at the end of the 6-week's programme. The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue.

18. Fatigue at 3-months Follow up: Chalder Fatigue Questionnaire (CFQ) [3-months follow-up (after the end of the 6-week's programme)]

    The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue.

19. Pain-related Anxiety, Fear and Avoidance at Baseline: Pain Anxiety Symptoms Scale-short Version (PASS-20) [Baseline (pre-treatment: up to one week before the programme)]

    The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at baseline (pre-treatment: up to one week before the programme). Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance.

20. Pain-related Anxiety, Fear and Avoidance at the End of Treatment: Pain Anxiety Symptoms Scale-short Version (PASS-20) [6-weeks (end of the programme)]

    The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at the end of the 6-week's programme. Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance.

21. Pain-related Anxiety, Fear and Avoidance at 3-months Follow up: Pain Anxiety Symptoms Scale-short Version (PASS-20) [3-months follow-up (after the end of the 6-week's programme)]

    The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at 3-months follow up after the end of the 6-week's programme. Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance.

22. Physical and Mental Function at Baseline: 12-Item Short-Form Health Survey (SF-12) [Baseline (pre-treatment: up to one week before the programme)]

    The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at baseline (pre-treatment: up to one week before the programme). The two subscale scores have a maximum score of 100, where higher scores indicated better function.

23. Physical and Mental Function at the End of Treatment: 12-Item Short-Form Health Survey (SF-12) [6-weeks (end of the programme)]

    The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at the end of the 6-week's programme. The two subscale scores have a maximum score of 100, where higher scores indicated better function.

24. Physical and Mental Function at 3-months Follow up: 12-Item Short-Form Health Survey (SF-12) [3-months follow-up (after the end of the 6-week's programme)]

    The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at 3-months follow up after the end of the 6-week's programme. The two subscale scores have a maximum score of 100, where higher scores indicated better function.

25. General Health Status and Quality of Life at Baseline: EuroQol (EQ-5D-5L) [Baseline (pre-treatment: up to one week before the programme)]

    The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at baseline (pre-treatment: up to one week before the programme). The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life.

26. General Health Status and Quality of Life at the End of Treatment: EuroQol (EQ-5D-5L) [6-weeks (end of the programme)]

    The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at the end of the 6-week's programme. The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life.

27. General Health Status and Quality of Life at 3-months Follow up: EuroQol (EQ-5D-5L) [3-months follow-up (after the end of the 6-week's programme)]

    The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at 3-months follow up after the end of the 6-week's programme. The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Feasibility Study Inclusion Criteria:

• Patients with an initial General Practitioner (GP)/hospital consultant referral to The Pennine Acute Hospitals NHS Trust with diagnoses of chronic low back pain, chronic widespread pain, fibromyalgia or CFS/ME, with a minimum symptom duration of 3 months.

• Patients referred to a rehabilitation programme for chronic pain/fatigue

• Patients aged ≥18 years

• Patients able to read/write in English

Exclusion Criteria:

• Patients with evidence of a serious underlying pathology, such as a current diagnosis of cancer

• Patients with severe mental health/cognitive functioning issues

Acceptability Study (qualitative interviews) Inclusion Criteria:

• Patients with an initial GP/hospital consultant referral to The Pennine Acute Hospitals National Health Service (NHS) Trust with diagnoses of chronic low back pain, chronic widespread pain, fibromyalgia or CFS/ME, with a minimum symptom duration of 3 months (as per the feasibility study).

• Patients who attended a minimum of one session of the rehabilitation programme, who consented to the study and completed the first questionnaire booklet. Patients do not need to have completed the programme, since the interviews will include patients who both completed and did not complete the programme.

• Qualified healthcare professionals delivering the rehabilitation programmes who received training in using the activity pacing framework: physiotherapists and psychological wellbeing practitioners employed by The Pennine Acute Hospitals NHS Trust and Pennine Care NHS Foundation Trust.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Pennine Acute Hospitals NHS Trust	Bury	Lancashire	United Kingdom	BL9 7TD

Sponsors and Collaborators

• Pennine Acute Hospitals NHS Trust
• University of Leeds
• National Institute for Health Research, United Kingdom

Investigators

• Principal Investigator: Deborah Antcliff, PhD, BSc, Pennine Acute Hospitals NHS Trust

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 27, 2018
• Informed Consent Form - Apr 27, 2018

More Information

Publications

None provided.

• Responsible Party: Deborah Antcliff, Senior Physiotherapist/Researcher, Pennine Acute Hospitals NHS Trust
• ClinicalTrials.gov Identifier: NCT03497585
• Other Study ID Numbers: IRAS:242203, V2.1, 27.04.18
• First Posted: Apr 13, 2018
• Last Update Posted: Dec 17, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Deborah Antcliff, Senior Physiotherapist/Researcher, Pennine Acute Hospitals NHS Trust: Rehabilitation; Pain Management
• Additional relevant MeSH terms: Fatigue Syndrome, Chronic; Fibromyalgia; Low Back Pain; Fatigue; Chronic Pain

Study Results

Participant Flow

Recruitment Details

For the feasibility study, patient recruitment occurred between 21st May 2018 and 3rd September 2019. Patients were recruited from those referred to a rehabilitation programme within a physiotherapy-led, out-patient service in a National Health Service (NHS) Trust in Northern England. The acceptability interviews involved patients (as above) and healthcare professionals (HCPs) delivering the programmes. HCP recruitment occurred between 18th September 2019 and 6th November 2019.

Pre-assignment Detail

This was a single-arm feasibility study. All patients received the same treatment, that is, they all attended the same rehabilitation programme that was underpinned by the activity pacing framework. Excluded from the study were those patients who did not meet the inclusion/exclusion criteria.

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Period Title: Overall Study
STARTED	112
COMPLETED	57
NOT COMPLETED	55

Baseline Characteristics

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Overall Participants	107
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.25 (12.83)
Sex: Female, Male (Count of Participants)
Female	92 86%
Male	15 14%
Race/Ethnicity, Customized (Count of Participants)
White (British, Irish, Other)	99 92.5%
Black (Caribbean, African)	1 0.9%
Mixed (White/Black, White/Asian, other)	3 2.8%
Asian (Indian, Pakistani, Bangladeshi, other)	3 2.8%
Asian Eastern (Chinese, other)	0 0%
Conditions (Count of Participants)
Low back pain	79 73.8%
Chronic widespread pain	52 48.6%
Fibromyalgia	29 27.1%
Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME)	12 11.2%
Other (e.g. osteoarthritis)	21 19.6%
Number of conditions (Count of Participants)
1 condition	41 38.3%
2 conditions	49 45.8%
3 conditions	12 11.2%
4 conditions	2 1.9%
5 conditions	2 1.9%

Outcome Measures

1. Primary Outcome

Title	Change in Activity Pacing Questionnaire (APQ-28) From Baseline to the End of the 6-week's Programme
Description	The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to assess the changes in activity pacing from baseline (pre-treatment: up to one week before the programme) to end of the programme (6-week's programme). Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
Time Frame	Change in activity pacing from baseline (pre-treatment: up to one week before the programme) to the end of the 6-week's programme

Outcome Measure Data

Analysis Population Description

Of the 107 participants who commenced the rehabilitation programme and provided baseline data (T1), 65 participants completed the data collection at the end of the 6-week rehabilitation programme. There were two missing answers for APQ-28 Activity adjustment.

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	65
APQ-28 Activity adjustment	0.70
APQ-28 Activity planning	0.99
APQ-28 Activity consistency	0.84
APQ-28 Activity acceptance	0.67
APQ-28 Activity progression	0.94

2. Secondary Outcome

Title	Activity Pacing at Baseline: Activity Pacing Questionnaire (APQ-28)
Description	The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to measure activity pacing at baseline (pre-treatment: up to one week before the programme). Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
Time Frame	Baseline (pre-treatment: up to one week before the programme)

Outcome Measure Data

Analysis Population Description

Included in these analyses are all 107 participants who provided data at baseline. There is one missing answer for APQ-28 Activity adjustment

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	107
APQ-28 Activity adjustment	1.83 (0.81)
APQ-28 Activity planning	1.49 (0.98)
APQ-28 Activity consistency	1.85 (0.94)
APQ-28 Activity acceptance	1.91 (0.92)
APQ-28 Activity progression	1.51 (0.95)

3. Secondary Outcome

Title	Activity Pacing at the End of Treatment: Activity Pacing Questionnaire (APQ-28)
Description	The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to measure activity pacing at the end of the 6-week's programme. Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
Time Frame	6-weeks (end of the programme)

Outcome Measure Data

Analysis Population Description

Of the 107 participants who completed baseline data (T1), 65 completed data collection at the end of the 6-week rehabilitation programme (T2). There were two missing answers for APQ-28 Activity adjustment.

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	65
APQ-28 Activity adjustment	2.43 (0.73)
APQ-28 Activity planning	2.42 (0.87)
APQ-28 Activity consistency	2.65 (0.74)
APQ-28 Activity acceptance	2.55 (0.72)
APQ-28 Activity progression	2.39 (0.89)

4. Secondary Outcome

Title	Activity Pacing at 3-months Follow up: Activity Pacing Questionnaire (APQ-28)
Description	The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to measure activity pacing at 3-months follow up after the end of the 6-week's programme. Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
Time Frame	3-months follow-up (after the end of the 6-week's programme)

Outcome Measure Data

Analysis Population Description

Of the 107 participants who completed baseline data collection (T1) and those who completed the end of treatment (T2) data collection, 52 participants completed the 3-month follow-up data collection (T3). There were two missing answers for APQ Activity adjustment.

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	52
APQ-28 Activity adjustment	2.33 (0.90)
APQ-28 Activity planning	2.06 (1.02)
APQ-28 Activity consistency	2.37 (0.72)
APQ-28 Activity acceptance	2.42 (0.95)
APQ-28 Activity progression	2.00 (0.91)

5. Secondary Outcome

Title	Pain at Baseline: 11-point Numerical Rating Scale (NRS) of Pain
Description	Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at baseline (pre-treatment: up to one week before the programme)
Time Frame	Baseline (pre-treatment: up to one week before the programme)

Outcome Measure Data

Analysis Population Description

107 participants completed the baseline questionnaire booklet. However, there was one missing answer for Current pain (n=106); and four missing answers for Usual pain (n=103).

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	106
Current pain	6.71 (1.96)
Usual pain	7.47 (1.69)

6. Secondary Outcome

Title	Pain at the End of Treatment (6-weeks): 11-point Numerical Rating Scale (NRS) of Pain
Description	Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at the end of the 6-week's programme.
Time Frame	6-weeks (end of the programme)

Outcome Measure Data

Analysis Population Description

All 65 participants completed the scales for current and usual pain in the 6-weeks (T2) questionnaire booklet. There were no missing answers

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	65
Current pain	5.31 (2.38)
Usual pain	6.62 (2.08)

7. Secondary Outcome

Title	Pain at 3-months Follow up: 11-point Numerical Rating Scale (NRS) of Pain
Description	Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at 3-months follow up after the end of the 6-week's programme
Time Frame	3-months follow-up (after the end of the 6-week's programme)

Outcome Measure Data

Analysis Population Description

52 participants completed the questionnaire booklets at 3-months follow-up. However, there were two missing answers for Usual pain.

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	52
Current pain	5.65 (2.31)
Usual pain	6.54 (1.93)

8. Secondary Outcome

Title	Depression at Baseline: Patient Health Questionnaire-9 (PHQ-9)
Description	The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression.
Time Frame	Baseline (pre-treatment: up to one week before the programme)

Outcome Measure Data

Analysis Population Description

Three missing answers from the 107 participants at baseline (T1)

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	104
Mean (Standard Deviation) [score on a scale]	13.26 (6.86)

9. Secondary Outcome

Title	Depression at the End of Treatment (6-weeks): Patient Health Questionnaire-9 (PHQ-9)
Description	The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at the end of the 6-week's programme. The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression.
Time Frame	6-weeks (end of the programme)

Outcome Measure Data

Analysis Population Description

Two missing answers from the 65 participants at T2

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	63
Mean (Standard Deviation) [score on a scale]	7.14 (6.09)

10. Secondary Outcome

Title	Depression at 3-months Follow-up: Patient Health Questionnaire-9
Description	The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression.
Time Frame	3-months follow-up (after the end of the 6-week's programme)

Outcome Measure Data

Analysis Population Description

One missing answer from the 52 participants at T3.

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	51
Mean (Standard Deviation) [score on a scale]	9.09 (5.76)

11. Secondary Outcome

Title	Anxiety at Baseline: Generalised Anxiety Disorder Assessment (GAD-7)
Description	The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety.
Time Frame	Baseline (pre-treatment: up to one week before the programme)

Outcome Measure Data

Analysis Population Description

One missing answer from the 107 participants at baseline (T1)

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	106
Mean (Standard Deviation) [score on a scale]	9.89 (5.92)

12. Secondary Outcome

Title	Anxiety at the End of Treatment (6-weeks): Generalised Anxiety Disorder Assessment (GAD-7)
Description	The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at the end of the 6-week's programme. The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety.
Time Frame	6-weeks (end of the programme)

Outcome Measure Data

Analysis Population Description

65 participants at 6-weeks data collection (T2)

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	65
Mean (Standard Deviation) [score on a scale]	5.40 (5.12)

13. Secondary Outcome

Title	Anxiety at 3-months Follow up: Generalised Anxiety Disorder Assessment (GAD-7)
Description	The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety.
Time Frame	3-months follow-up (after the end of the 6-week's programme)

Outcome Measure Data

Analysis Population Description

52 participants provided data at 3-months (T3)

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	52
Mean (Standard Deviation) [score on a scale]	6.10 (5.23)

14. Secondary Outcome

Title	Self-efficacy at Baseline: Pain Self Efficacy Questionnaire (PSEQ)
Description	The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at baseline (pre-treatment: up to one week before the programme). The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low.
Time Frame	Baseline (pre-treatment: up to one week before the programme)

Outcome Measure Data

Analysis Population Description

All 107 participants at T1 provided an answer

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	107
Mean (Standard Deviation) [score on a scale]	25.67 (11.93)

15. Secondary Outcome

Title	Self-efficacy at the End of Treatment: Pain Self Efficacy Questionnaire (PSEQ)
Description	The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at the end of the 6-week's programme. The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low.
Time Frame	6-weeks (end of the programme)

Outcome Measure Data

Analysis Population Description

All 65 participants at T2 provided an answer

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	65
Mean (Standard Deviation) [score on a scale]	36.29 (14.12)

16. Secondary Outcome

Title	Self-efficacy at 3-months Follow up: Pain Self Efficacy Questionnaire (PSEQ)
Description	The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at 3-months follow up after the end of the 6-week's programme. The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low.
Time Frame	3-months follow-up (after the end of the 6-week's programme)

Outcome Measure Data

Analysis Population Description

All 52 participants at 3-months follow-up (T3) provided an answer

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	52
Mean (Standard Deviation) [score on a scale]	34.68 (14.26)

17. Secondary Outcome

Title	Fatigue at Baseline: Chalder Fatigue Questionnaire (CFQ)
Description	The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue.
Time Frame	Baseline (pre-treatment: up to one week before the programme)

Outcome Measure Data

Analysis Population Description

107 participants completed the first questionnaire booklet (T1). However, there were four missing answers for physical fatigue (n=103) and one missing answer for mental fatigue (n-106)

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	106
Physical fatigue	14.81 (4.54)
Mental fatigue	8.83 (2.94)

18. Secondary Outcome

Title	Fatigue at the End of Treatment: Chalder Fatigue Questionnaire (CFQ)
Description	The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at the end of the 6-week's programme. The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue.
Time Frame	6-weeks (end of the programme)

Outcome Measure Data

Analysis Population Description

65 participants completed the 6-weeks questionnaire booklet (T2). However, there were three missing answers on the Physical fatigue subscale (n=62) and one missing answer on the Mental fatigue scale (n=64).

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	64
Physical fatigue	20.31 (3.92)
Mental fatigue	11.28 (2.43)

19. Secondary Outcome

Title	Fatigue at 3-months Follow up: Chalder Fatigue Questionnaire (CFQ)
Description	The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue.
Time Frame	3-months follow-up (after the end of the 6-week's programme)

Outcome Measure Data

Analysis Population Description

Three missing answers for the Physical fatigue subscale; one missing answer for the Mental fatigue subscale

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	51
Physical fatigue	18.18 (4.16)
Mental fatigue	10.92 (2.34)

20. Secondary Outcome

Title	Pain-related Anxiety, Fear and Avoidance at Baseline: Pain Anxiety Symptoms Scale-short Version (PASS-20)
Description	The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at baseline (pre-treatment: up to one week before the programme). Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance.
Time Frame	Baseline (pre-treatment: up to one week before the programme)

Outcome Measure Data

Analysis Population Description

One missing answer

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	106
Mean (Standard Deviation) [score on a scale]	13.14 (5.98)

21. Secondary Outcome

Title	Pain-related Anxiety, Fear and Avoidance at the End of Treatment: Pain Anxiety Symptoms Scale-short Version (PASS-20)
Description	The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at the end of the 6-week's programme. Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance.
Time Frame	6-weeks (end of the programme)

Outcome Measure Data

Analysis Population Description

One missing answer

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	64
Mean (Standard Deviation) [score on a scale]	10.28 (5.89)

22. Secondary Outcome

Title	Pain-related Anxiety, Fear and Avoidance at 3-months Follow up: Pain Anxiety Symptoms Scale-short Version (PASS-20)
Description	The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at 3-months follow up after the end of the 6-week's programme. Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance.
Time Frame	3-months follow-up (after the end of the 6-week's programme)

Outcome Measure Data

Analysis Population Description

All 52 participants at 3-months follow-up (T3) provided an answer for this subscale.

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	52
Mean (Standard Deviation) [score on a scale]	12.12 (5.79)

23. Secondary Outcome

Title	Physical and Mental Function at Baseline: 12-Item Short-Form Health Survey (SF-12)
Description	The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at baseline (pre-treatment: up to one week before the programme). The two subscale scores have a maximum score of 100, where higher scores indicated better function.
Time Frame	Baseline (pre-treatment: up to one week before the programme)

Outcome Measure Data

Analysis Population Description

Two missing answers for the physical and mental function subscales

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	105
Physical function	33.96 (8.82)
Mental function	40.00 (11.36)

24. Secondary Outcome

Title	Physical and Mental Function at the End of Treatment: 12-Item Short-Form Health Survey (SF-12)
Description	The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at the end of the 6-week's programme. The two subscale scores have a maximum score of 100, where higher scores indicated better function.
Time Frame	6-weeks (end of the programme)

Outcome Measure Data

Analysis Population Description

Two missing answers on the Physical and Mental function subscales

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	63
Physical function	38.82 (9.06)
Mental function	45.83 (11.48)

25. Secondary Outcome

Title	Physical and Mental Function at 3-months Follow up: 12-Item Short-Form Health Survey (SF-12)
Description	The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at 3-months follow up after the end of the 6-week's programme. The two subscale scores have a maximum score of 100, where higher scores indicated better function.
Time Frame	3-months follow-up (after the end of the 6-week's programme)

Outcome Measure Data

Analysis Population Description

Five missing answers on the Physical and Mental function subscales

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	47
Physical function	36.55 (9.81)
Mental function	44.56 (10.60)

26. Secondary Outcome

Title	General Health Status and Quality of Life at Baseline: EuroQol (EQ-5D-5L)
Description	The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at baseline (pre-treatment: up to one week before the programme). The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life.
Time Frame	Baseline (pre-treatment: up to one week before the programme)

Outcome Measure Data

Analysis Population Description

Seven missing answers from the 107 participants at baseline (T1).

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	100
Mean (Standard Deviation) [score on a scale]	0.42 (0.25)

27. Secondary Outcome

Title	General Health Status and Quality of Life at the End of Treatment: EuroQol (EQ-5D-5L)
Description	The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at the end of the 6-week's programme. The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life.
Time Frame	6-weeks (end of the programme)

Outcome Measure Data

Analysis Population Description

Six missing answers from the 65 participants at 6-weeks (T2) data collection

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	59
Mean (Standard Deviation) [score on a scale]	0.56 (0.28)

28. Secondary Outcome

Title	General Health Status and Quality of Life at 3-months Follow up: EuroQol (EQ-5D-5L)
Description	The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at 3-months follow up after the end of the 6-week's programme. The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life.
Time Frame	3-months follow-up (after the end of the 6-week's programme)

Outcome Measure Data

Analysis Population Description

Seven missing answers from the 52 participants who responded to the 3-months follow-up (T3)

Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Measure Participants	45
Mean (Standard Deviation) [score on a scale]	0.52 (0.29)

Adverse Events

Time Frame	There were no adverse events throughout the duration of the study, that is, between the start of recruitment in May 2018 and the end of the 3-months follow-up data collection in December 2019.
Adverse Event Reporting Description	There were zero adverse events among a possible sample of 107 patients who commenced the rehabilitation programme; nor were there any adverse events during the interviews with the five healthcare professionals.
Arm/Group Title	Activity Pacing Framework
Arm/Group Description	Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
All Cause Mortality
	Activity Pacing Framework
	Affected / at Risk (%)	# Events
Total	0/107 (0%)
Serious Adverse Events
	Activity Pacing Framework
	Affected / at Risk (%)	# Events
Total	0/107 (0%)
Other (Not Including Serious) Adverse Events
	Activity Pacing Framework
	Affected / at Risk (%)	# Events
Total	0/107 (0%)

Limitations/Caveats

The target sample size of n=50 patients at 3-months follow-up (T3) for the feasibility study was attained (actual sample at T3: n=52). Despite recruiting to target for the feasibility study, this sample was not powered with a control arm to determine treatment effectiveness. The generalisability of this study is limited to a sample of predominantly females, of white ethnic origin and recruited from only one Pain Service in Northern England, United Kingdom (UK).

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.