Effects of an Aerobic Exercise Program on Cardiovascular Risk in Patients With Chronic Kidney Disease or Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Arterial stiffness
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental group
Aerobic exercise program during 6 weeks (3 session / week), with 45 minutes ergocycle exercise
干预措施: Aerobic exercise program (Behavioral)
Physical activity oriented group
Therapeutic education during 6 weeks (1 phone call / week), with advice and exchanges to improve physical activity
干预措施: Therapeutic education (Behavioral)
Control group
No intervention group during 6 weeks, participants have to maintain their lifestyle
结局指标
主要结局
Arterial stiffness
时间窗: From baseline to 12-weeks follow-up (three time points).
Arterial stiffness is measured with pulse wave velocity (PWV). The unit is metres per second.
次要结局
- Endothelial Dysfunction(From baseline to 12-weeks follow-up (three time points).)
- Cardiovascular risk blood biomarkers(From baseline to 6-weeks (two time points), before and after the intervention.)
- Inflammatory Blood biomarkers(From baseline to 6-weeks (two time points), before and after the intervention.)
- Senescence Blood biomarkers(From baseline to 6-weeks (two time points), before and after the intervention.)
- Heart rate(From baseline to 12-weeks follow-up (three time points).)
- Heart rate variability(From baseline to 12-weeks follow-up (three time points).)
- Blood pressure(From baseline to 12-weeks follow-up (three time points).)
- Quality of life level(From baseline to 6-weeks (two time points), before and after the intervention.)
- Physical activity level(From baseline to 6-weeks (two time points), before and after the intervention.)
研究者
Jérôme Bouchan
Researcher PhD
University of Franche-Comté