跳至主要内容
临床试验/NCT04102410
NCT04102410已完成不适用

Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
volume of oxygen consumed (VO2) (in ml/min/kg) at the first ventilatory threshold (SV1)

研究概览

简要总结

Cardiac rehabilitation includes aerobic and anaerobic training adapted to cardiovascular pathology for which cardiac rehabilitation is prescribed. It is essential to adapt the content of these cardiac rehabilitation sessions to optimize aerobic and anaerobic performance and quality of life. Improvement of the first ventilatory threshold is one of the main objectives since it illustrates the adaptation of the patient to submaximal exercise, typical of everyday life.

The research laboratory "Autonomous Nervous System - Epidemiology, Physiology, Engineering, Health" (SPA-EPIS) has an international expertise in training optimization in top-athletes. He have shown the importance of the relationship between the power-force-velocity profile and athletes performances.

详细描述

In this sudy, each patient has a force and a velocity that can be optimized with training to achieve maximum power. This optimization can be evaluated through a force-velocity profile, measured from an only sprint on a cycloergometer.

The hypothesis that force-velocity profile could be used in cardiac rehabilitation in coronary patients to induce a force-velocity balance adapted through personalized sessions and regular medical follow-up.

This prospective, controlled, randomized and open label study will attempt to evaluate further the relevance of force or velocity training based on the initial force-velocity profile of coronary patients included in the cardiac rehabilitation program in the University Hospital of Saint-Etienne.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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 within the last 6 months
  • Medical revascularization (angioplasty ± stenting) or surgical (coronary artery bypass)
  • During initial effort test: Maximum aerobic power≥ 60 watts for women and ≥ 80 watts for men
  • Patient affiliated or beneficiary to social security
  • Signed informed consent

排除标准

  • Significant co-morbidities limited practice of physical activity
  • Inability to submit to medical monitoring of the program
  • Patient deprived of liberty or patient under guardianship
  • Pregnant woman

结局指标

主要结局

volume of oxygen consumed (VO2) (in ml/min/kg) at the first ventilatory threshold (SV1)

时间窗: Months: 0 and 2

Change in VO2 (volume of oxygen in ml/min/kg) at the first ventilatory threshold (SV1) during a Cardio-Pulmonary Exercise Test (CPET).

次要结局

  • Voluntary muscle power (in kg) during a dynamic muscle testing on quadriceps(Months: 0 and 2)
  • Sedentary life (in hour/day)(Month: 0)
  • Maximum aerobic power (in watt)(Months: 0 and 2)
  • Physical activity (in Metabolic Equivalent of Task (MET)-min/week)(Month: 0)
  • SF-12 questionnaire score(Months: 0 and 2)
  • VO2 max (volume of oxygen maximum in ml/min/kg)(Months: 0 and 2)
  • Value of muscular endurance (in min) during a dynamic muscle testing on quadriceps(Months: 0 and 2)
  • Standard Deviation of the Normal R-R interval (SDNN) index(Months: 0 and 2)
  • Power at first ventilatory threshold (SV1)(Months: 0 and 2)
  • Voluntary muscle power (in kg) during a static muscle testing on quadriceps(Months: 0 and 2)
  • Value of muscular endurance (in min) during a static muscle testing on quadriceps(Months: 0 and 2)
  • BaroReflex Sensitivity (BRS) (in ms/mmHg)(Months: 0 and 2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验