Fatigue in People With Rheumatoid Arthritis- Randomized Controlled Trial

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

Detailed Description
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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.

Official Title
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The Effect of Person-centered Physical Therapy on Fatigue Related Variables in Persons With Rheumatoid Arthritis- Randomized Controlled Trial

Conditions
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Rheumatoid Arthritis, Fatigue

Intervention / Treatment
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* Behavioral: Person-centered physical therapy intervention program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention program<br>Person-centered physical therapy intervention program | Behavioral: Person-centered physical therapy intervention program<br>* Comparison of person-centered physical therapy and control group<br>|
| No Intervention: Control group<br>Health care as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fatigue | questionnaire | 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during previous week | VAS | 6months | 
| Physical function | Performance based test | 6months | 
| Disease activity | DAS-28 | 6 months | 
| Health-related quality of life | Questionnaire | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, Rheumatoid Arthritis, Physical Therapy, Person-Centred Care