Aerobic exercise to reduce heart risk in people with rheumatoid arthritis or chronic kidney disease
Effects of an Aerobic Exercise Program on Cardiovascular Risk in Patients With Chronic Kidney Disease or Rheumatoid Arthritis
This program will test whether a six-week individualized aerobic exercise plan can lower heart-related risk in people with rheumatoid arthritis or stage III–IV chronic kidney disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Franche-Comté Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Besançon) |
| Trial ID | NCT07469540 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with rheumatoid arthritis (DAS28 ≥ 2.6) or chronic kidney disease stage III–IV (eGFR 20–45 ml/min/1.73 m²) who are medically cleared to exercise and covered by the French social security system.
Not a fit: Patients who cannot safely perform exercise (due to uncontrolled blood pressure, active high-dose corticosteroid use, pregnancy, major cognitive impairment, severe comorbidities preventing exercise, or legal incapacity) are unlikely to benefit from the program.
Why it matters
Potential benefit: If successful, the program could improve arterial stiffness and reduce systemic inflammation, lowering cardiovascular risk and potentially improving long-term outcomes for these patients.
How similar studies have performed: Prior studies show aerobic exercise can improve vascular function and reduce inflammation in people with chronic inflammatory conditions, but applying a short individualized 6-week program specifically to CKD or RA patients with evaluation of immunosenescence is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Besançon
- EPHI Platform — Besançon, France (Recruiting)
Study contacts
- Study coordinator: Jérôme Bouchan, PhD
- Email: jerome.bouchan@umlp.fr
- Phone: +33363082323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.