FatigueNCT06001970
Activity Pacing for Fatigue Management
An observational study of Fatigue and Chronic Condition, run by Northumbria University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue, Chronic Condition, Self-regulation
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 May 2023to Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with chronic conditions who experience fatigue
Who may be able to join
- Diagnosed with a chronic condition
- Experience fatigue
- Ambulatory
Who cannot join
- Children
- Wheelchair users
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Northumbria University
Newcastle
Ioulia Barakou
About this study
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
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.
Read the 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.
- Conditions
- Fatigue, Chronic Condition, Self-regulation, Physical Activity, Activity Pacing
- Keywords
- physical activity behavior, self-regulation, fatigue, chronic condition
- Medical subject headings
- Fatigue, Chronic Disease, Self-Control, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived fatigue
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.
Measured: 1 point in time measuring for the past 7 days
Physical activity
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 .
Measured: 1 point in time measuring for the past 7 days
Engagement in Pacing and Perceived Risk of Overactivity
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.
Measured: 1 point in time measuring for the past 7 days
Perceived Fatigue
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.
Measured: 1 point in time measuring for the past 7 days
Objective Physical Activity
Participants will be invited to wear an Actigraph for 7 full days.
Measured: 7 days
Secondary outcomes (2)
Self-regulation
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.
Measured: 1 point in time measuring for the past 7 days
Health-related Quality of Life
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.
Measured: 1 point in time measuring for the past 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start10 May 2023
- Primary completion30 Oct 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001970
- Sponsor's protocol ID
- 313465
- Status last verified
- Aug 2023
- First submitted
- 5 May 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barakou I, Seves BL, Abonie U, Finch T, Hackett K, Hettinga F. Unravelling the diversity of pacing behaviours in adults with chronic conditions: a cross-sectional study. BMJ Open. 2026 May 27;16(5):e104566. doi: 10.1136/bmjopen-2025-104566.
PubMed 42203292
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06001970
- Acronym / sponsor ID
- 313465
- Conditions
- Fatigue, Chronic Condition, Self-regulation, Physical Activity, Activity Pacing
- Keywords
- physical activity behavior, self-regulation, fatigue, chronic condition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust
- Study start
- 10 May 2023 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with chronic conditions who experience fatigue
Key inclusion criteria (3 listed)
- Diagnosed with a chronic condition
- Experience fatigue
- Ambulatory
Key exclusion criteria (2 listed)
- Children
- Wheelchair users
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perceived fatigue
Time frame: 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.
Physical activity
Time frame: 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 .
Engagement in Pacing and Perceived Risk of Overactivity
Time frame: 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.
Perceived Fatigue
Time frame: 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.
Objective Physical Activity
Time frame: 7 days
Participants will be invited to wear an Actigraph for 7 full days.
2 secondary outcomes
Self-regulation
Time frame: 1 point in time measuring for the past 7 days
Health-related Quality of Life
Time frame: 1 point in time measuring for the past 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Derived from this study: PubMed 42203292Barakou I, Seves BL, Abonie U, Finch T, Hackett K, Hettinga F. Unravelling the diversity of pacing behaviours in adults with chronic conditions: a cross-sectional study. BMJ Open. 2026 May 27;16(5):e104566. doi: 10.1136/bmjopen-2025-104566.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue and Chronic Condition, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ioulia Barakou, MSc (07752464152, ioulia.barakou@northumbria.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived fatigue (time frame: 1 point in time measuring for the past 7 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06001970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.