Aerobic exercise to reduce heart risk in people with rheumatoid arthritis or chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will randomize participants with rheumatoid arthritis or stage III–IV chronic kidney disease to an individualized aerobic exercise program, a therapeutic education program delivered by phone, or no intervention. The exercise group will perform three 45-minute sessions per week for six weeks at 60–80% of heart rate reserve, with clinic visits at baseline, after the 6-week intervention, and at a 6-week follow-up. Outcomes include measures of arterial stiffness and endothelial function (for example pulse wave velocity), plus blood analyses of inflammation and markers of immunosenescence. The trial compares physiological and blood-biomarker changes between groups to see if the exercise program produces clinically meaningful cardiovascular benefits.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of Chronic Kidney Disease (CKD) or Rheumatoid Arthritis (RA), with no other risk factors related to the disease.
* Having a glomerular filtration rate between 45 and 20 ml/min/1.73 m², corresponding to stages III and IV not on dialysis for patients with CKD ; or have a DAS 28 score ≥ 2.6 points for patients with RA.
* Have a medical certificate stating that there are no adverse reactions to physical activity.
* Affiliation with a French social security scheme or beneficiary of such a scheme.

Exclusion Criteria:

* Unstabilised corticosteroid therapy and/or \>10mg prednisone/day
* Uncontrolled high blood pressure
* Pregnant women
* Impaired higher functions making it impossible to understand and adhere to an aerobic exercise program
* Inability to perform physical exercise, regardless of the cause (neurological, central or peripheral, cardiovascular or respiratory, or musculoskeletal)
* Legal incapacity or limited legal capacity
* Subject unlikely to cooperate with the study and/or low cooperation anticipated by the investigator
* Subject without health insurance
* Subject is in the exclusion period of another study involving human subjects that may interfere with the results of this study, particularly by affecting inflammatory status and the cardiovascular system.

Where it's running

• EPHI Platform
  Besançon, France Recruiting

Study contacts

• Study coordinator: Jérôme Bouchan, PhD
• Email: jerome.bouchan@umlp.fr
• Phone: +33363082323

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.