Fatigue in People With Rheumatoid Arthritis- Randomized Controlled Trial
NCT ID: NCT02120963
Last Updated: 2018-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2013-11-30
2014-10-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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intervention program
Person-centered physical therapy intervention program
Person-centered physical therapy intervention program
Comparison of person-centered physical therapy and control group
Control group
Health care as usual
No interventions assigned to this group
Interventions
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Person-centered physical therapy intervention program
Comparison of person-centered physical therapy and control group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
65 Years
ALL
No
Sponsors
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Sahlgrenska University Hospital
OTHER
Göteborg University
OTHER
Responsible Party
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Principal Investigators
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Kaisa Mannerkorpi, Ass prof
Role: PRINCIPAL_INVESTIGATOR
Göteborg University, Dept of Rheumatology
Locations
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rheumatology clinic at Sahlgrenska University Hospital
Gothenburg, , Sweden
Countries
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Other Identifiers
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FatigueRA-RCT
Identifier Type: -
Identifier Source: org_study_id
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