NCT06001970

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. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

May 10, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

May 5, 2023

Last Update Submit

August 14, 2023

Conditions

FatigueChronic ConditionSelf-regulationPhysical ActivityActivity Pacing

Keywords

physical activity behaviorself-regulationfatiguechronic condition

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • Objective Physical Activity

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

    7 days

Secondary Outcomes (2)

  • Self-regulation

    1 point in time measuring for the past 7 days

  • Health-related Quality of Life

    1 point in time measuring for the past 7 days

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults with chronic conditions who experience fatigue

You may qualify if:

  • Diagnosed with a chronic condition
  • Experience fatigue
  • Ambulatory

You may not qualify if:

  • Children
  • Wheelchair users

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle, United Kingdom

RECRUITING

MeSH Terms

Conditions

FatigueChronic DiseaseSelf-ControlMotor Activity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic ProcessesSocial BehaviorBehavior

Central Study Contacts

Ioulia Barakou, MSc

CONTACT

07752464152ioulia.barakou@northumbria.ac.uk

Florentina Hettinga, PhD

CONTACT

0191 227 3989florentina.hettinga@northumbria.ac.uk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2023

First Posted

August 21, 2023

Study Start

May 10, 2023

Primary Completion

October 30, 2023

Study Completion

March 1, 2024

Last Updated

August 21, 2023

Record last verified: 2023-08

Locations

GB(1)