Activity Pacing for Fatigue Management

Physical Activity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06001970
• Other study ID #: 313465
• Status: Recruiting
• Start date: May 10, 2023
• Est. completion date: March 2024

Study information

• Verified date: August 2023
• Source: Northumbria University
• Contact: Ioulia Barakou, MSc
• Phone: 07752464152
• Email: ioulia.barakou[@]northumbria.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: March 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with a chronic condition

• Experience fatigue

• Ambulatory

Exclusion Criteria:

• Children

• Wheelchair users

Related Conditions & MeSH terms

• Chronic Disease
• Fatigue
• Physical Activity
• Self-regulation

Locations

Country	Name	City	State
United Kingdom	Northumbria University	Newcastle

Sponsors (2)

Lead Sponsor	Collaborator
Northumbria University	Newcastle-upon-Tyne Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 point in time measuring for the past 7 days
Primary	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 .	1 point in time measuring for the past 7 days
Primary	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.	1 point in time measuring for the past 7 days
Primary	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.	1 point in time measuring for the past 7 days
Primary	Objective Physical Activity	Participants will be invited to wear an Actigraph for 7 full days.	7 days
Secondary	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.	1 point in time measuring for the past 7 days
Secondary	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.	1 point in time measuring for the past 7 days