Arthritis, RheumatoidRhumatExNCT02855801
Exercise Training in Patients With Rheumatoid Arthritis and Cryotherapy
A study testing constant exercise, cryotherapy and intermittent exercise in people with Arthritis, Rheumatoid, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The main objective of this project is to study, in patients with rheumatoid arthritis, the effects of an intermittent type exercise associated with cryotherapy on the level of inflammation during its recovery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- constant exercise, cryotherapy and intermittent exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Dec 2016
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women >18 years old, < 80 years old
- Signature of informed consent for participation
- Affiliation to a social security scheme or French beneficiary of such a regime.
- confirmed rheumatoid arthritis and monitoring by the rheumatology department of the University Hospital of Besancon.
- If there is a corticosteroid therapy, it must be stable for at least 1 month and less than or equal to 10 mg of prednisone equivalent per day
- Clinical and biological activity will be moderate (ie not in remission and not severe based on Disease Activity Score 28 joints - DAS 28 - to be between 2 and 6
- Patients could be treated with DMARDs (Disease-Modifying Drugs).
Who cannot join
- Patient under guardianship, curatorship, under judicial protection, major incapable
- Patients whose body mass index (BMI) greater than 30,
- Pathology incompatible with the completion of a cycle ergometer exercise (heart, vascular, respiratory, orthopedic ...)
- Change in DAS28 greater than 1.2 in the previous 3 months Inclusion
- A patient with a DAS28 > 6
- about the cold: Raynaud's syndrome, cold known allergy, sickle cell anemia, cryoglobulinemia, uncontrolled hypertension
- Patient unable to follow protocol because of cognitive, psychiatric or language difficulties.
- Inability to follow protocol for causes related to health problems (unrelated Rheumatoid Arthritis) or socio-professional.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Régional Universitaire
Besançon, Franche-Comté, 25030
About this study
Official title: Exercise Training in Patients With Rheumatoid Arthritis and Cryotherapy: Feasibility Study
The main objective of this project is to study, in patients with rheumatoid arthritis, the effects of an intermittent type exercise associated with cryotherapy on the level of inflammation during its recovery.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- constant exercise, cryotherapy, intermittent exercise
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
constant exerciseOther
cryotherapyOther
intermittent exerciseOther
| Study group | Role | What they receive |
|---|---|---|
| constant exercise without cryotherapy | Experimental | constant exercise without cryotherapy Receives: Other: constant exercise |
| constant exercise with cryotherapy | Experimental | constant exercise with cryotherapy Receives: Other: constant exercise; Other: cryotherapy |
| intermittent exercise, no cryotherapy | Experimental | intermittent exercise without cryotherapy Receives: Other: intermittent exercise |
| intermittent exercise and cryotherapy | Experimental | intermittent exercise with cryotherapy Receives: Other: cryotherapy; Other: intermittent exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma concentration of C-reactive protein
Measured: 48 hours after the end of the exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startJun 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clement Pati, MD, Principal investigator, CHRU Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855801
- Sponsor's protocol ID
- P/2012/139
- Acronym
- RhumatEx
- Status last verified
- Aug 2016
- First submitted
- 2 Aug 2016
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training in Patients With Rheumatoid Arthritis and Cryotherapy: Feasibility Study
- ClinicalTrials.gov ID
- NCT02855801
- Acronym / sponsor ID
- RhumatEx / P/2012/139
- Conditions
- Arthritis, Rheumatoid
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Aug 2016 (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 main objective of this project is to study, in patients with rheumatoid arthritis, the effects of an intermittent type exercise associated with cryotherapy on the level of inflammation during its recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| constant exercise without cryotherapy | Experimental | Other: constant exerciseconstant exercise without cryotherapy |
| constant exercise with cryotherapy | Experimental | Other: constant exercise, Other: cryotherapyconstant exercise with cryotherapy |
| intermittent exercise, no cryotherapy | Experimental | Other: intermittent exerciseintermittent exercise without cryotherapy |
| intermittent exercise and cryotherapy | Experimental | Other: cryotherapy, Other: intermittent exerciseintermittent exercise with cryotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women >18 years old, < 80 years old
- Signature of informed consent for participation
- Affiliation to a social security scheme or French beneficiary of such a regime.
- confirmed rheumatoid arthritis and monitoring by the rheumatology department of the University Hospital of Besancon.
- If there is a corticosteroid therapy, it must be stable for at least 1 month and less than or equal to 10 mg of prednisone equivalent per day
Key exclusion criteria (8 listed)
- Patient under guardianship, curatorship, under judicial protection, major incapable
- Patients whose body mass index (BMI) greater than 30,
- Pathology incompatible with the completion of a cycle ergometer exercise (heart, vascular, respiratory, orthopedic ...)
- Change in DAS28 greater than 1.2 in the previous 3 months Inclusion
- A patient with a DAS28 > 6
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 |
|---|---|---|
| constant exercise | Other | constant exercise with cryotherapy, constant exercise without cryotherapy |
| cryotherapy | Other | constant exercise with cryotherapy, intermittent exercise and cryotherapy |
| intermittent exercise | Other | intermittent exercise and cryotherapy, intermittent exercise, no cryotherapy |
Primary outcome
plasma concentration of C-reactive protein
Time frame: 48 hours after the end of the exercise
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- 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.
Clement Pati, MD principal investigator
CHRU Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing constant exercise, cryotherapy and intermittent exercise in people with Arthritis, Rheumatoid, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 15 Feb 2017. 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 France. 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 was stopped early. Results are not available in the source record.
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?
plasma concentration of C-reactive protein (time frame: 48 hours after the end of the exercise). 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 Feb 2017.