Activity Pacing for Fatigue Management

Sponsor
Northumbria University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06001970
Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust (Other)
54
1
9.7
5.6

Study Details

Study Description

Brief Summary

This project will focus on perceived fatigue as a barrier to physical activity participation and will explore if and how activity pacing, fatigue management, and self-regulation strategies can help to overcome this barrier in adults with chronic conditions who experience fatigue symptoms. The main aims are:

  1. To demonstrate the differences and similarities on activity pacing, perceived fatigue, self-regulation, physical activity, and health-related quality of life in adults who experience fatigue by comparing individuals who have been through an activity pacing program or not.

  2. To explore thoughts, experiences, needs, and perspectives on activity pacing of adults with fatigue and health professionals as well as any ideas for future development of an optimal intervention.

Participants will be invited to complete questionnaires on several variables (activity pacing, physical activity, fatigue, health-related quality of life, and self-regulation of physical activity). In addition, they will be invited to wear an Actigraph for 7 full days and they will also be invited to a focus group interview.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Activity pacing is a fatigue management strategy that regulates energy and activity levels while maintaining or increasing engagement in physical activity. This approach is particularly beneficial for individuals with chronic conditions who experience significant fatigue as they often struggle with sustained physical activity participation due to recurring patterns of overexertion and subsequent fatigue or pain. Therefore, activity pacing strategies are important because individuals learn to manage fatigue symptoms, optimize physical activity behaviour, and accomplish a more stable activity pacing pattern, which will improve their health-related quality of life and well-being.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    54 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Activity Pacing, Fatigue Management, and Self-regulation Strategies as a Promising Approach for Managing Fatigue Symptoms and for Promoting Physical Activity in Adults Who Experience Fatigue
    Actual Study Start Date :
    May 10, 2023
    Anticipated Primary Completion Date :
    Oct 30, 2023
    Anticipated Study Completion Date :
    Mar 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Adults who experience fatigue and have been through an activity pacing program

    Adults with chronic conditions who experience fatigue recruited from Cresta Fatigue Clinic, Newcastle, UK

    Adults who experience fatigue and have not been through an activity pacing program

    Adults with chronic conditions who experience fatigue recruited from the waiting list of Cresta Fatigue Clinic, Newcastle, UK

    Health professionals working on activity pacing

    Health professionals who are working on Cresta Fatigue Clinic, Newcastle, UK

    Outcome Measures

    Primary Outcome Measures

    1. Perceived fatigue [1 point in time measuring for the past 7 days]

      Fatigue Severity Scale is a 9-item questionnaire assessing the impact of perceived fatigue in adults with chronic disorders. FSS is valid and reliable to determine the impact of perceived fatigue among several clinical populations.

    2. Physical activity [1 point in time measuring for the past 7 days]

      Self-reported PA: IPAQ is a 7-item measure that assesses the intensity of physical activity and sitting time in their daily lives . It has been validated in adults with stroke .

    3. Engagement in Pacing and Perceived Risk of Overactivity [1 point in time measuring for the past 7 days]

      The Activity Pacing Questionnaire (APQ) is a 7-item measure assessing activity pacing and risk of overactivity. Reliability and construct validity have been investigated and the paper is in preparation.

    4. Perceived Fatigue [1 point in time measuring for the past 7 days]

      2)FACIT-F (version 4) is a 40-item questionnaire evaluating self-reported fatigue and its influence on everyday activities and function among adults with cancer and older people experiencing fatigue . FACIT-F is valid and reliable in several patient populations.

    5. Objective Physical Activity [7 days]

      Participants will be invited to wear an Actigraph for 7 full days.

    Secondary Outcome Measures

    1. Self-regulation [1 point in time measuring for the past 7 days]

      Physical Activity Self-Regulation scale (PASR-12) is a 12-item measure assessing self-regulation for physical activity. PASR-12 has demonstrated validity and reliability in older adults.

    2. Health-related Quality of Life [1 point in time measuring for the past 7 days]

      RAND-12 health status inventory is a 12-item questionnaire that evaluates the health-related quality of life. Literature supports acceptable construct validity and test-retest reliability of the RAND-12 among clinical populations.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosed with a chronic condition

    • Experience fatigue

    • Ambulatory

    Exclusion Criteria:
    • Children

    • Wheelchair users

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northumbria University Newcastle United Kingdom

    Sponsors and Collaborators

    • Northumbria University
    • Newcastle-upon-Tyne Hospitals NHS Trust

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Northumbria University
    ClinicalTrials.gov Identifier:
    NCT06001970
    Other Study ID Numbers:
    • 313465
    First Posted:
    Aug 21, 2023
    Last Update Posted:
    Aug 21, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Northumbria University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 21, 2023