Aerobic Exercise Program Followed by Cold Water Immersion: Effects on Arthritis Patients Arterial… (NCT03911830) | Clinical Trial Compass
CompletedNot Applicable
Aerobic Exercise Program Followed by Cold Water Immersion: Effects on Arthritis Patients Arterial Stiffness
France18 participantsStarted 2017-11-11
Plain-language summary
The purpose of this study is to analyze the long-term effects of a physical exercise program on the cardiovascular system of people with Rheumatoid Arthritis (RA).
Indeed, it is recognized that RA patients have cardiovascular problems and that regular physical exercise (exercise training) may be beneficial for the disease complications, incluse the cardiovascular risk. Unfortunately, these patients do not exercise enough for fear of joint pain or for fear of deteriorating their general physical condition.
It is known that intermittent exercises, ie combining low and high intensity work phases, are particularly effective in the cardiovascular field. As it is possible that the high intensity phases be more difficult to sustain than the low intensity phases (joint pain and degradation of the inflammatory status), the investigators propose to study the effects of cold water immersion in the legs after performing this exercise, because the cold being recognized as limiting the pain and improving the inflammatory status.
Who can participate
Age range
20 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient (male or female) between the ages of 20 and 80, diagnosed with rheumatoid arthritis without any other risk factor in relation to RA, and having a DAS-28 score between 2.6 and 6.
* Signature of informed consent
* Affiliation to a French social security scheme or beneficiary of such a scheme.
Exclusion Criteria:
* Unstabilized corticosteroids and / or\> 10 mg prednisone / day;
* Unstabilized hypertension;
* Pregnant women;
* Alteration of higher functions making comprehension and adherence to a conditioning program impossible (mini mental test \<24); Patient who has performed intense physical exercise / physiotherapy within the previous 24 hours the interventions planned in this project;
* Contraindication to immersion in cold water (a dermatological factor and / or vascular or respiratory cardiac dysfunction and / or cold intolerance syndrome and / or syndrome such as Raynaud's Syndrome);
* Inability to perform physical exercise, regardless of its origin (neurological, central or peripheral, cardiovascular or respiratory or musculoskeletal);
* Legal incapacity or limited legal capacity;
* Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator;
* Subject without health insurance;
* Subject being in the exclusion period of another study or provided for by the "National Volunteer File".
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pressure wave analysis
Timeframe: Week 6
2
Assessment of central arterial compliance
Timeframe: Week 6
Trial details
NCT IDNCT03911830
SponsorCentre Hospitalier Universitaire de Besancon