INPACT-AS: Increasing Physical Activity in Ankylosing Spondylitis: a Randomised Controlled Trial

Sponsor

University of Dublin, Trinity College (Other)

Overall Status

Completed

CT.gov ID

NCT02374502

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ankylosing spondylitis is a chronic inflammatory condition that mostly affects the spine. This results in back pain and stiffness, and causes difficulty with daily activities. Physical activity and exercise are key components of the management of ankylosing spondylitis, however many adults with ankylosing spondylitis do not meet physical activity recommendations. This study aims to investigate the effects of a twelve week intervention designed to increase physical activity and exercise in adults with ankylosing spondylitis.

Condition or Disease	Intervention/Treatment	Phase
Spondylitis, Ankylosing	Behavioral: Brief Intervention	N/A

Detailed Description

Participants will be randomly allocated to one of two groups. An intervention group will receive individual consultations with a physiotherapist. The aim of the meetings will be to motivate and support participants on an individual basis, with the goal of increasing weekly physical activity. The second group, the control group, will continue with their current management strategies. All participants will be assessed at baseline, post-intervention (after twelve weeks) and after a three month follow-up period. The primary outcome measure will be free-living physical activity over one week.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Increasing Physical Activity in Ankylosing Spondylitis (INPACT-AS): a Randomised Controlled Trial

Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brief Intervention Group Participants in this intervention group will receive a twelve week 'Brief Intervention' delivered by a physiotherapist. Participants will have an initial consultation with a physiotherapist, followed by a number of follow-up sessions. The number and timing of follow-up sessions will be at the participant's discretion (a minimum of 3 and a maximum of 11 over the duration of the study). The follow-up sessions can be face-to-face, over the telephone, or video conferencing depending on participant preference. Participants may additionally opt-in for a weekly email or text message reminder of physical activity goals.	Behavioral: Brief Intervention 'Brief Intervention' is the term used to mean verbal advice, discussion, negotiation or encouragement, with or without written or other support or follow-up. 'Brief Interventions' provide a structured way to deliver advice and involve the provision of formal help and follow-up. They aim to equip people with tools to change attitudes and handle underlying problems.
No Intervention: Control Group Participants in this control group will be asked to continue with their current levels of physical activity.

Arm

Intervention/Treatment

Experimental: Brief Intervention Group

Participants in this intervention group will receive a twelve week 'Brief Intervention' delivered by a physiotherapist. Participants will have an initial consultation with a physiotherapist, followed by a number of follow-up sessions. The number and timing of follow-up sessions will be at the participant's discretion (a minimum of 3 and a maximum of 11 over the duration of the study). The follow-up sessions can be face-to-face, over the telephone, or video conferencing depending on participant preference. Participants may additionally opt-in for a weekly email or text message reminder of physical activity goals.

Behavioral: Brief Intervention

'Brief Intervention' is the term used to mean verbal advice, discussion, negotiation or encouragement, with or without written or other support or follow-up. 'Brief Interventions' provide a structured way to deliver advice and involve the provision of formal help and follow-up. They aim to equip people with tools to change attitudes and handle underlying problems.

No Intervention: Control Group

Participants in this control group will be asked to continue with their current levels of physical activity.

Outcome Measures

Primary Outcome Measures

Free-living Physical Activity [up to 12 weeks follow-up]
Actigraph monitor GT3X-BT worn during waking hours over 7 days.

Secondary Outcome Measures

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [up to 12 weeks follow-up]
Bath Ankylosing Spondylitis Functional Index (BASFI) [up to 12 weeks follow-up]
Bath Ankylosing Spondylitis Global score (BAS-G) [up to 12 weeks follow-up]
Ankylosing Spondylitis Quality of Life questionnaire (ASQoL) [up to 12 weeks follow-up]
Cardiorespiratory capacity [up to 12 weeks follow-up]
VO2peak measured by submaximal, incremental treadmill test
Body Composition [up to 12 weeks follow-up]
Bioelectric impedance analysis & waist/hip circumference
Flexibility [up to 12 weeks follow-up]
Bath Ankylosing Spondylitis Metrology Index (BASMI) & Chest Expansion
Muscular fitness [up to 12 weeks follow-up]
Push-up test and curl-up test
Exercise Barriers and Beliefs Scale (EBBS) [up to 12 weeks follow-up]
Arthritis self-efficacy questionnaire (Ankylosing Spondylitis version) [up to 12 weeks follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of ankylosing spondylitis (diagnosed by a rheumatologist).
Able to read and understand the English language.
On stable pharmacological management.

Exclusion Criteria:

Under 18 years of age, or over 64 years of age
Unable to read and understand the English language
Concomitant cardiac, respiratory or neurological condition
Co-morbidity restricting physical activity or inability to ambulate without a mobility aid
Acute lower limb injury
Uncontrolled epilepsy
Cognitive difficulties limiting ability to follow safety and protocol instructions
Pregnant
Change in medication (type of dosage) within six weeks of testing
On beta-blocker medication.