Rheumatoid ArthritisNCT01228812
Physical Activity Behavior of Rheumatoid Arthritis Patients and Healthy Controls
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 compare physical activity behaviour of rheumatoid arthritis patients with healthy matched controls. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 505 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2010to Sep 2010
- 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 40 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients from the RA patients group will be selected in the Rheumatology Department of the Centre Hospitalier universitaire Vaudois in Lausanne. Healthy matched controls will be randomly selected from a cohort study conducted in Lausanne.
Who may be able to join
- Rheumatoid arthritis
- Functional classes I, II and III
- Age 40 to 80 years
- Stable disease activity
- Stable DMARDS last 3 months
Who cannot join
- Functional classes IV
- Inflammatory flare
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: An Observational Study of Physical Activity Behavior of Swiss Rheumatoid Arthritis Patients and Healthy Matched Controls
The purpose of the study is to compare physical activity behaviour of rheumatoid arthritis patients with healthy matched controls.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, physical activity
- 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 | |
| Healthy subjects | Healthy subjects matched for age and sex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
PAFQ
Measured: Up to 4 weeks
Secondary outcomes (4)
Functional status
HAQ
Measured: Up to 4 weeks
Pain
VAS
Measured: Up to 4 weeks
Fatigue
VAS
Measured: Up to 4 weeks
Disease activity
DAS 28
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yves Henchoz, University of Lausanne
- Investigators
- Alexander KL So, PhD, FRCP, Study director, Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, SuisseYves Henchoz, PhD, Principal investigator, Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, SuisseJean Dudler, PD, MER, Study chair, Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, SuisseFrançois Bastardot, MD, Study chair, Etude CoLaus, Centre Hospitalier Universitaire Vaudois, LausannePeter Vollenweider, MD, Study chair, Etude CoLaus, Centre Hospitalier Universitaire Vaudois, LausanneIdris Guessous, MD, Study chair, Unité d'Epidémiologie Populationnelle, Département de médecine communautaire et de premier recours, Hôpitaux Universitaires de Genève
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228812
- Sponsor's protocol ID
- PR_AP
- Status last verified
- May 2018
- First submitted
- 26 Oct 2010
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Henchoz Y, Bastardot F, Guessous I, Theler JM, Dudler J, Vollenweider P, So A. Physical activity and energy expenditure in rheumatoid arthritis patients and matched controls. Rheumatology (Oxford). 2012 Aug;51(8):1500-7. doi: 10.1093/rheumatology/kes067. Epub 2012 Apr 25.
PubMed 22539478
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Physical Activity Behavior of Swiss Rheumatoid Arthritis Patients and Healthy Matched Controls
- ClinicalTrials.gov ID
- NCT01228812
- Acronym / sponsor ID
- PR_AP
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 27 Oct 2010 (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 compare physical activity behaviour of rheumatoid arthritis patients with healthy matched controls.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RA patients | – | –Patients with Rheumatoid Arthritis |
| Healthy subjects | – | –Healthy subjects matched for age and sex |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients from the RA patients group will be selected in the Rheumatology Department of the Centre Hospitalier universitaire Vaudois in Lausanne. Healthy matched controls will be randomly selected from a cohort study conducted in Lausanne.
Key inclusion criteria (5 listed)
- Rheumatoid arthritis
- Functional classes I, II and III
- Age 40 to 80 years
- Stable disease activity
- Stable DMARDS last 3 months
Key exclusion criteria (2 listed)
- Functional classes IV
- Inflammatory flare
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
Physical activity
Time frame: Up to 4 weeks
PAFQ
4 secondary outcomes
Functional status
Time frame: Up to 4 weeks
Pain
Time frame: Up to 4 weeks
Fatigue
Time frame: Up to 4 weeks
Disease activity
Time frame: Up to 4 weeks
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 17 May 2018.
- Derived from this study: PubMed 22539478Henchoz Y, Bastardot F, Guessous I, Theler JM, Dudler J, Vollenweider P, So A. Physical activity and energy expenditure in rheumatoid arthritis patients and matched controls. Rheumatology (Oxford). 2012 Aug;51(8):1500-7. doi: 10.1093/rheumatology/kes067. Epub 2012 Apr 25.
- Individual participant dataSharing planned: No
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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
Yves Henchoz, PhD principal investigator
Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, Suisse
Jean Dudler, PD, MER study chair
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 5 inclusion and 2 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 17 May 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 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?
Physical activity (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01228812, which also lists 1 linked publication.
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 17 May 2018.