Effects of an Aerobic Exercise Program on Cardiovascular Risk in Patients With Chronic Kidney Disease or Rheumatoid Arthritis

Обзор

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.

Вмешательства

• Поведенческое 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%.
• Поведенческое Therapeutic education
  Therapeutic education for 6 weeks, with one telephone call per week. Each call includes advices and exchanges to improve physical activity level.

Первичные конечные точки

• Arterial stiffness [Срок оценки: From baseline to 12-weeks follow-up (three time points).]

Вторичные конечные точки (9)

• Endothelial Dysfunction [Срок оценки: From baseline to 12-weeks follow-up (three time points).]
• Cardiovascular risk blood biomarkers [Срок оценки: From baseline to 6-weeks (two time points), before and after the intervention.]
• Inflammatory Blood biomarkers [Срок оценки: From baseline to 6-weeks (two time points), before and after the intervention.]
• Senescence Blood biomarkers [Срок оценки: From baseline to 6-weeks (two time points), before and after the intervention.]
• Heart rate [Срок оценки: From baseline to 12-weeks follow-up (three time points).]
• Heart rate variability [Срок оценки: From baseline to 12-weeks follow-up (three time points).]
• Blood pressure [Срок оценки: From baseline to 12-weeks follow-up (three time points).]
• Quality of life level [Срок оценки: From baseline to 6-weeks (two time points), before and after the intervention.]
• Physical activity level [Срок оценки: From baseline to 6-weeks (two time points), before and after the intervention.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• EPHI Platform — Besançon

Идентификаторы

NCT: NCT07469540 · 2024-A02525-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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