跳至主要内容
临床试验/NCT06107452
NCT06107452招募中不适用

Customization of Cardiac Readaptation Based on Force-velocity Profile and Heart Rate Variability: A Controlled and Randomized Study

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
110
试验地点
1
主要终点
The root mean square of successive differences in heart rate or RMSSD

研究概览

简要总结

Cardiac readaptation aims to mitigate cardiovascular risks and enhance the quality of life among coronary patients. Our research laboratory has an international expertise in training optimization in top-athletes and a previous study has demonstrated the efficacy of optimizing cardiac rehabilitation through the power-force-velocity profile (PFVP). The findings exhibited significant improvements in aerobic capacity, muscular strength, and cardiovascular parameters among patients who were trained based on their PFVP. Guided training utilizing heart rate variability (HRV) is also garnering increasing interest as a means to optimize training load and promote recovery

详细描述

Our study aims to evaluate the application of HRV in regulating training load based on fatigue levels in cardiac rehabilitation patients utilizing the PFVP framework.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute Coronary Syndrome treated in the last 6 months
  • Medical revascularization (angioplasty ± stenting) or surgical (coronary artery bypass)
  • Initial CPETt: MPA ≥ 60w in women and ≥80w in men
  • Informed consent

排除标准

  • Significant co-morbidities limited practice of physical activity

结局指标

主要结局

The root mean square of successive differences in heart rate or RMSSD

时间窗: Baseline to 2 months

The root mean square of successive differences in heart rate or RMSSD will be measured from a nocturnal Holter ECG recording at the end of 8 weeks of exercise retraining and compared with the initial pre-training value. weeks of exercise re-training and compared with the initial pre-training value.

次要结局

  • Value of maximum oxygen consumption(Baseline to 2 months)
  • Assessment of the ANS sympathetic branch(Baseline to 2 months)
  • Assessment of the ANS parasympathetic branch(Baseline to 2 months)
  • non-invasive measurement of arterial stiffness(Baseline to 2 months)
  • assessment of PFVP evolution(Baseline to 2 months)
  • assessment of physical a activity and sedentary behavior(Baseline to 2 months)
  • quality of life assessment(Baseline to 2 months)
  • measurement of upper and lower limb muscle strength(Baseline to 2 months)
  • assessment of subjective fatigue(Baseline to 2 months)
  • biological data(Baseline to 2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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