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CompletedNCT02120963RAFatigueRCTUpdated Aug 15, 2018

Fatigue in People With Rheumatoid Arthritis- Randomized Controlled Trial

An interventional study of Person-centered physical therapy intervention program in Fatigue and Rheumatoid Arthritis, sponsored by Göteborg University. Completed at 1 site in Sweden. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-08-15.

Sponsored by Göteborg University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Fatigue
  • Rheumatoid Arthritis

Keywords

  • Fatigue
  • Rheumatoid Arthritis
  • Physical Therapy
  • Person-Centred Care
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 70 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Göteborg University is the lead sponsor of 265 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • aging 20-65 years, disease duration >3 year, stable pharmacological treatment

Exclusion criteria

Exclusion Criteria:

  • Other serious physical or mental illness, lack of knowledge in Swedish language making answering the questionnaires impossible.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    intervention program

    Person-centered physical therapy intervention program

    Behavioral: Person-centered physical therapy intervention program

  • No intervention
    Control group

    Health care as usual

Interventions

  • BehavioralPerson-centered physical therapy intervention program

    Comparison of person-centered physical therapy and control group

06

What researchers measure

Primary outcomes

  1. fatigue

    questionnaire

    Time frame: 6months

Secondary outcomes

  1. Pain during previous week

    VAS

    Time frame: 6months

  2. Physical function

    Performance based test

    Time frame: 6months

  3. Disease activity

    DAS-28

    Time frame: 6 months

  4. Health-related quality of life

    Questionnaire

    Time frame: 6 months

07

Study locations

1 site
  • rheumatology clinic at Sahlgrenska University Hospital
    Gothenburg, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02120963
Lead sponsor
Göteborg University
Collaborators
Sahlgrenska University Hospital
Responsible party
Sponsor
First posted
Apr 23, 2014
Start date
Nov 2013
Primary completion
Oct 10, 2014
Completion
Oct 10, 2014
Last update
Aug 15, 2018

Study contacts

Kaisa Mannerkorpi, Ass prof
principal investigator · Göteborg University, Dept of Rheumatology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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