Fatigue in People With Rheumatoid Arthritis- Randomized Controlled Trial (RAFatigueRCT)

August 14, 2018 updated by: Göteborg University

The Effect of Person-centered Physical Therapy on Fatigue Related Variables in Persons 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • rheumatology clinic at Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fatigue
Time Frame: 6months
questionnaire
6months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Collaborators

Sahlgren´s University Hospital

Investigators

  • Principal Investigator: Kaisa Mannerkorpi, Ass prof, Göteborg University, Dept of Rheumatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

October 10, 2014

Study Completion (Actual)

October 10, 2014

Study Registration Dates

First Submitted

January 15, 2014

First Submitted That Met QC Criteria

April 22, 2014

First Posted (Estimate)

April 23, 2014

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FatigueRA-RCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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