- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06001970
Activity Pacing for Fatigue Management
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
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:
- 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.
- 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.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ioulia Barakou, MSc
- Phone Number: 07752464152
- Email: ioulia.barakou@northumbria.ac.uk
Study Contact Backup
- Name: Florentina Hettinga, PhD
- Phone Number: 0191 227 3989
- Email: florentina.hettinga@northumbria.ac.uk
Study Locations
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Newcastle, United Kingdom
- Recruiting
- Northumbria University
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Contact:
- Ioulia Barakou
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosed with a chronic condition
- Experience fatigue
- Ambulatory
Exclusion Criteria:
- Children
- Wheelchair users
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
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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
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Health professionals working on activity pacing
Health professionals who are working on Cresta Fatigue Clinic, Newcastle, UK
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived fatigue
Time Frame: 1 point in time measuring for the past 7 days
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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.
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1 point in time measuring for the past 7 days
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Physical activity
Time Frame: 1 point in time measuring for the past 7 days
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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 .
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1 point in time measuring for the past 7 days
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Engagement in Pacing and Perceived Risk of Overactivity
Time Frame: 1 point in time measuring for the past 7 days
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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.
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1 point in time measuring for the past 7 days
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Perceived Fatigue
Time Frame: 1 point in time measuring for the past 7 days
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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.
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1 point in time measuring for the past 7 days
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Objective Physical Activity
Time Frame: 7 days
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Participants will be invited to wear an Actigraph for 7 full days.
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7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-regulation
Time Frame: 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.
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1 point in time measuring for the past 7 days
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Health-related Quality of Life
Time Frame: 1 point in time measuring for the past 7 days
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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.
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1 point in time measuring for the past 7 days
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 313465
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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