Fatigue in People With Rheumatoid Arthritis- Randomized Controlled Trial (RAFatigueRCT)
Primary Purpose
Fatigue, Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Person-centered physical therapy intervention program
Sponsored by
About this trial
This is an interventional treatment trial for Fatigue focused on measuring Fatigue, Rheumatoid Arthritis, Physical Therapy, Person-Centred Care
Eligibility Criteria
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.
Sites / Locations
- rheumatology clinic at Sahlgrenska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention program
Control group
Arm Description
Person-centered physical therapy intervention program
Health care as usual
Outcomes
Primary Outcome Measures
fatigue
questionnaire
Secondary Outcome Measures
Pain during previous week
VAS
Physical function
Performance based test
Disease activity
DAS-28
Health-related quality of life
Questionnaire
Full Information
NCT ID
NCT02120963
First Posted
January 15, 2014
Last Updated
August 14, 2018
Sponsor
Göteborg University
Collaborators
Sahlgren´s University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02120963
Brief Title
Fatigue in People With Rheumatoid Arthritis- Randomized Controlled Trial
Acronym
RAFatigueRCT
Official Title
The Effect of Person-centered Physical Therapy on Fatigue Related Variables in Persons With Rheumatoid Arthritis- Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
October 10, 2014 (Actual)
Study Completion Date
October 10, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Sahlgren´s University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Rheumatoid Arthritis
Keywords
Fatigue, Rheumatoid Arthritis, Physical Therapy, Person-Centred Care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention program
Arm Type
Experimental
Arm Description
Person-centered physical therapy intervention program
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Health care as usual
Intervention Type
Behavioral
Intervention Name(s)
Person-centered physical therapy intervention program
Intervention Description
Comparison of person-centered physical therapy and control group
Primary Outcome Measure Information:
Title
fatigue
Description
questionnaire
Time Frame
6months
Secondary Outcome Measure Information:
Title
Pain during previous week
Description
VAS
Time Frame
6months
Title
Physical function
Description
Performance based test
Time Frame
6months
Title
Disease activity
Description
DAS-28
Time Frame
6 months
Title
Health-related quality of life
Description
Questionnaire
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaisa Mannerkorpi, Ass prof
Organizational Affiliation
Göteborg University, Dept of Rheumatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
rheumatology clinic at Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Fatigue in People With Rheumatoid Arthritis- Randomized Controlled Trial
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