Fatigue in People With Rheumatoid Arthritis- Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis; Fatigue
• Interventions: Behavioral: Person-centered physical therapy intervention program

• Registration Number: NCT02120963
• Lead Sponsor: Göteborg University

Brief Summary

Aim: To study if a person-centered physical therapy intervention program contributes to diminished fatigue in people with Rheumatoid Arthritis (RA).

Detailed Description

The effect of person-centered physical therapy on fatigue related variables in peoples with Rheumatoid Arthritis- Randomized controlled trial Aim: To study if a person-centered physical therapy intervention program contributes to diminished fatigue in people with RA.

Hypothesis: That the person-centered treatment program diminishes fatigue and its consequences on daily life.

Design: A controlled randomized interventional trial, assessing effectiveness of intervention.

Methods:

Selection: Seventy persons with diagnosis of RA and fatigue over 50 (0-100) will be recruited from the rheumatology clinic at Sahlgrenska University Hospital. Participants are randomized to an intervention group or a waiting list control group.

Intervention: The 12-week intervention period begins with an individual person-centered meeting to develop an individualized feasible self-care plan for the participant with extra focus on health-enhancing physical activity, stress management (relaxation exercise training and modified mindfulness techniques) and balance in daily life. A written consent, aiming to increase coherence, is signed. The participants will be asked to keep a journal about their strategies and reflections. Follow up meetings and contacts will be planned according to personal preferences.

Procedure: The participants are invited to a clinical examination before and after the 12-week intervention and at 6-month follow-up, assessing demographic data, disease activity, inflammation parameters, physical capacity and questionnaires of health status in RA. Primary outcome are questionnaires of single item- and multidimensional fatigue.

Analysis: Effects of the interventions will be analyzed using non-parametric statistics for between-group changes over time. Within-group changes over time will be analyzed for each group.

Expected results. New knowledge of fatigue is of importance for improvement of overall health of people with RA, as fatigue influences all aspects of their life, both private life and employment, thus decreasing the quality of life.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-23
• Primary Completion: 2014-10-10
• Study Completion: 2014-10-10
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• aging 20-65 years, disease duration >3 year, stable pharmacological treatment

Exclusion Criteria

• Other serious physical or mental illness, lack of knowledge in Swedish language making answering the questionnaires impossible.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention program	Person-centered physical therapy intervention program	Person-centered physical therapy intervention program

Primary Outcome Measures

Name	Time	Method
fatigue	6months	questionnaire

Secondary Outcome Measures

Name	Time	Method
Physical function	6months	Performance based test
Health-related quality of life	6 months	Questionnaire
Pain during previous week	6months	VAS
Disease activity	6 months	DAS-28

Trial Locations

Locations (1)

rheumatology clinic at Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden