FatigueRAFatigueRCTNCT02120963
Fatigue in People With Rheumatoid Arthritis- Randomized Controlled Trial
A study testing Person-centered physical therapy intervention program in people with Fatigue and Rheumatoid Arthritis, run by Göteborg University at 1 site in Sweden.
Trial summary
Aim: To study if a person-centered physical therapy intervention program contributes to diminished fatigue in people with Rheumatoid Arthritis (RA). Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Fatigue, Rheumatoid Arthritis
- What is being tested?
- Person-centered physical therapy intervention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2013to 10 Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aging 20-65 years, disease duration >3 year, stable pharmacological treatment
Who cannot join
- Other serious physical or mental illness, lack of knowledge in Swedish language making answering the questionnaires impossible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
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.
- Conditions
- Fatigue, Rheumatoid Arthritis
- Being tested
- Person-centered physical therapy intervention program
- Keywords
- Fatigue, Rheumatoid Arthritis, Physical Therapy, Person-Centred Care
- Medical subject headings
- Fatigue, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Person-centered physical therapy intervention programBehavioural
Comparison of person-centered physical therapy and control group
| Study group | Role | What they receive |
|---|---|---|
| intervention program | Experimental | Person-centered physical therapy intervention program Receives: Behavioral: Person-centered physical therapy intervention program |
| Control group | No intervention | Health care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
fatigue
questionnaire
Measured: 6months
Secondary outcomes (4)
Pain during previous week
VAS
Measured: 6months
Physical function
Performance based test
Measured: 6months
Disease activity
DAS-28
Measured: 6 months
Health-related quality of life
Questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startNov 2013
- Primary completion10 Oct 2014
- Study completion10 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Sponsor
- Investigators
- Kaisa Mannerkorpi, Ass prof, Principal investigator, Göteborg University, Dept of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120963
- Sponsor's protocol ID
- FatigueRA-RCT
- Acronym
- RAFatigueRCT
- Status last verified
- Aug 2018
- First submitted
- 15 Jan 2014
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Person-centered Physical Therapy on Fatigue Related Variables in Persons With Rheumatoid Arthritis- Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02120963
- Acronym / sponsor ID
- RAFatigueRCT / FatigueRA-RCT
- Conditions
- Fatigue, Rheumatoid Arthritis
- Keywords
- Fatigue, Rheumatoid Arthritis, Physical Therapy, Person-Centred Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Study start
- Nov 2013 (actual)
- Primary completion
- 10 Oct 2014 (actual)
- Study completion
- 10 Oct 2014 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention program | Experimental | Behavioral: Person-centered physical therapy intervention programPerson-centered physical therapy intervention program |
| Control group | No intervention | –Health care as usual |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aging 20-65 years, disease duration >3 year, stable pharmacological treatment
Key exclusion criteria (1 listed)
- Other serious physical or mental illness, lack of knowledge in Swedish language making answering the questionnaires impossible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Person-centered physical therapy intervention programComparison of person-centered physical therapy and control group | Behavioural | intervention program |
Primary outcome
fatigue
Time frame: 6months
questionnaire
4 secondary outcomes
Pain during previous week
Time frame: 6months
Physical function
Time frame: 6months
Disease activity
Time frame: 6 months
Health-related quality of life
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaisa Mannerkorpi, Ass prof principal investigator
Göteborg University, Dept of Rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Person-centered physical therapy intervention program in people with Fatigue and Rheumatoid Arthritis, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fatigue (time frame: 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.