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Completed

NCT Number: NCT02120963

Fatigue in People With Rheumatoid Arthritis- Randomized Controlled Trial

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

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

rheumatology clinic at Sahlgrenska University Hospital

Gothenburg, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Person-centered physical therapy intervention program

Behavioral

Comparison of person-centered physical therapy and control group

Primary outcomes

  1. fatigue

    Time frame: 6months

    questionnaire

Secondary outcomes

  1. Pain during previous week

    Time frame: 6months

    VAS

  2. Physical function

    Time frame: 6months

    Performance based test

  3. Disease activity

    Time frame: 6 months

    DAS-28

  4. Health-related quality of life

    Time frame: 6 months

    Questionnaire

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Sahlgrenska University Hospital

Registry information

Official study title

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

Acronym: RAFatigueRCT

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 23, 2014
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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