Effects of an Aerobic Exercise Program on Cardiovascular Risk in Patients With Chronic Kidney Disease or Rheumatoid Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aerobic exercise program, Therapeutic education.
- Who it may be relevant to
- Registry conditions: Aerobic Exercise, Rhumatoid Arthisis, Chronic Kidney Disease, Cardiovascular (CV) Risk. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this clinical trial is to determine whether an aerobic exercise program can reduce cardiovascular risk in patients with systemic inflammation, such as those with rheumatoid arthritis and chronic kidney disease. The main questions this study aims to address are: * Does an individualized aerobic exercise program reduce cardiovascular risk, as assessed arterial stiffness and endothelial function ? * What are the effects of this exercise program on inflammation and immunosenescence? Researchers will compare an individualized aerobic exercise program with a therapeutic education program (consisting of educational phone calls only) and a control group with no intervention. Participants will: * Perform three physical activity sessions per week for six weeks (45-minute sessions at 60-80% of heart rate reserve); * Attend clinic visits at baseline, after the 6-week intervention, and at a 6-week follow-up after the intervention; * Undergo assessments including pulse wave velocity, hyperemic reactivity, and blood analyses.
Interventions
- Behavioral Aerobic exercise program
Aerobic exercise program during 6 weeks, with 3 sessions / week. Each session includes 45 minutes of ergocycle, with 9 cycles of 4 minutes at 60% of heart rate and 1 minute at 80%. - Behavioral Therapeutic education
Therapeutic education for 6 weeks, with one telephone call per week. Each call includes advices and exchanges to improve physical activity level.
Primary outcome measures
- Arterial stiffness [Time frame: From baseline to 12-weeks follow-up (three time points).]
Secondary outcome measures (9)
- Endothelial Dysfunction [Time frame: From baseline to 12-weeks follow-up (three time points).]
- Cardiovascular risk blood biomarkers [Time frame: From baseline to 6-weeks (two time points), before and after the intervention.]
- Inflammatory Blood biomarkers [Time frame: From baseline to 6-weeks (two time points), before and after the intervention.]
- Senescence Blood biomarkers [Time frame: From baseline to 6-weeks (two time points), before and after the intervention.]
- Heart rate [Time frame: From baseline to 12-weeks follow-up (three time points).]
- Heart rate variability [Time frame: From baseline to 12-weeks follow-up (three time points).]
- Blood pressure [Time frame: From baseline to 12-weeks follow-up (three time points).]
- Quality of life level [Time frame: From baseline to 6-weeks (two time points), before and after the intervention.]
- Physical activity level [Time frame: From baseline to 6-weeks (two time points), before and after the intervention.]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- EPHI Platform — Besançon
Identifiers
NCT: NCT07469540 · 2024-A02525-42