Rheumatoid ArthritisNCT01596348
Exercise Perceptions and Preferences Among Rheumatoid Arthritis Patients
An observational study of Rheumatoid Arthritis, run by University of Lausanne at 1 site in Switzerland.
Trial summary
The purpose of the study is to analyse exercise behaviour of rheumatoid arthritis patients. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2011to Nov 2011
- Phase
- Observational
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be selected in the Rheumatology Department of the Centre Hospitalier universitaire Vaudois in Lausanne.
Who may be able to join
- Rheumatoid arthritis
- Age 30 to 80 years
Who cannot join
- Language difficulties and no help from family members or friends
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois, Département de l'Appareil Locomoteur
Lausanne
About this study
Official title: Perceived Exercise Benefits, Barriers and Preferences Among Swiss Rheumatoid Arthritis Patients
The purpose of the study is to analyse exercise behaviour of rheumatoid arthritis patients.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Exercise, Barriers, Benefits, Preferences, Stages of change
- Medical subject headings
- Arthritis, Rheumatoid, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RA patients | Patients with Rheumatoid Arthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise status
- Trained
- Active
- Irregularly active
- Partially active
- Inactive
Exercise stages of change
Prochaska 1992:
- Precontemplation
- Contemplation
- Preparation
- Action
- Maintenance
Perceived exercise benefits
Questionnaire developped by YH based on existing qualitive studies
Perceived exercise barriers
Questionnaire developped by Brittain et al. 2011
Exercise preferences
Developped by YH based on previous studies
Secondary outcomes (5)
Functional status
Health Assessment Questionanire (Guillemin et al. 1991)
Pain
Visual analogue scale (VAS)
Fatigue
VAS
Disease activity
Disease activity score 28 (DAS 28), based on the number of tender and swollen joints and the erythrocite sedimentation rate (ESR)
Quality of life
Arthritis Impact Measurement Scales 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startJun 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Investigators
- Alexander KL So, PhD, FRCP, Study director, Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, Suisse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596348
- Sponsor's protocol ID
- PR_Ex
- Status last verified
- May 2012
- First submitted
- 21 Jun 2011
- Last updated
- 11 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceived Exercise Benefits, Barriers and Preferences Among Swiss Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT01596348
- Acronym / sponsor ID
- PR_Ex
- Conditions
- Rheumatoid Arthritis
- Keywords
- Exercise, Barriers, Benefits, Preferences, Stages of change
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Study start
- Jun 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 11 May 2012 (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.
The purpose of the study is to analyse exercise behaviour of rheumatoid arthritis patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RA patients | – | –Patients with Rheumatoid Arthritis |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected in the Rheumatology Department of the Centre Hospitalier universitaire Vaudois in Lausanne.
Key inclusion criteria (2 listed)
- Rheumatoid arthritis
- Age 30 to 80 years
Key exclusion criteria (1 listed)
- Language difficulties and no help from family members or friends
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exercise status
* Trained * Active * Irregularly active * Partially active * Inactive
Exercise stages of change
Prochaska 1992: * Precontemplation * Contemplation * Preparation * Action * Maintenance
Perceived exercise benefits
Questionnaire developped by YH based on existing qualitive studies
Perceived exercise barriers
Questionnaire developped by Brittain et al. 2011
Exercise preferences
Developped by YH based on previous studies
5 secondary outcomes
Functional status
Pain
Fatigue
Disease activity
Quality of life
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 11 May 2012.
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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.
Alexander KL So, PhD, FRCP study director
Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, Suisse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by University of Lausanne at 1 site in Switzerland.
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 2 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 11 May 2012. 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 Switzerland. 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?
Exercise status. The study lists 5 primary outcomes in all. 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 11 May 2012.