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Fatigue in People With Rheumatoid Arthritis- Randomized Controlled Trial

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02120963
Acronym
RAFatigueRCT
Enrollment
70
Registered
2014-04-23
Start date
2013-11-30
Completion date
2014-10-10
Last updated
2018-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue, Rheumatoid Arthritis

Keywords

Fatigue, Rheumatoid Arthritis, Physical Therapy, Person-Centred Care

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.

Interventions

BEHAVIORALPerson-centered physical therapy intervention program

Comparison of person-centered physical therapy and control group

Sponsors

Sahlgrenska University Hospital
CollaboratorOTHER
Göteborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
fatigue6monthsquestionnaire

Secondary

MeasureTime frameDescription
Pain during previous week6monthsVAS
Physical function6monthsPerformance based test
Disease activity6 monthsDAS-28
Health-related quality of life6 monthsQuestionnaire

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026