Use and Validation of the 6-minute Stepper Test in in Patients With Cardiac Pathologies Needing Rehabilitation and Reeducation (CVRR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Internal validity of the 6 minutes step test (ST6)
研究概览
简要总结
The objective is to study the validity of the 6-minute stepper test (ST6) in order to determine tolerance to effort in cardiovascular patients
详细描述
The 6-minute stepper test (ST6) is an test used and validated in patients with respiratory disorders (chronic obstructive pulmonary disease) in order to evaluate their tolerance to exercise. It is well tolerated and reproducible in these patients, with the advantage that it can be performed without spatial constraints.
However, this test is not yet used in cardiology. This study proposes to validate the ST6, to evaluate the exercise tolerance of patients suffering from cardiovascular pathologies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Age ≥ 18 years old,
- •Patient with a cardiac pathology (coronary bypass, valve replacement, heart transplant, coronary angioplasty),
- •Registered in Cardiovascular Rehabilitation at the Mitterie Clinic,
- •Number of rehabilitation sessions at least equal to 30,
- •Ejection fraction ≥ 45%,
- •Signed written consent of the patient,
- •Affiliation to a social security scheme.
排除标准
- •Cardiac decompensation,
- •Severe functional limitation,
- •Unstable acute coronary syndrome,
- •Decompensated heart failure,
- •Severe ventricular rhythm disorders,
- •Presence of an intracardiac thrombus with high embolic risk,
- •Presence of a medium to large pericardial effusion (effusion of more than 10mm circumferential or 14mm localized on ultrasound),
- •Recent history (months prior to inclusion) of thrombophlebitis with or without pulmonary embolism,
- •Severe and/or symptomatic left ventricular ejection obstruction,
- •Any progressive inflammatory and/or infectious disease,
- •Severe pulmonary arterial hypertension,
- •Oxygen therapy,
- •Musculoskeletal or balance problems that would limit the ability to do any of the following the fiscal year.
- •Pregnant or breastfeeding women,
- •Incapacity to consent (including persons under guardianship or curatorship)
结局指标
主要结局
Internal validity of the 6 minutes step test (ST6)
时间窗: Day 0
The number of steps taken in 6 minutes with the ST6 will be measured twice on the first day of the cardiovascular rehabilitation and education. The second ST6 will be performed 30 minutes after the first. Internal validity will be studied by calculating the intra-class correlation coefficient (ICC) of the number of steps from the two ST6 carried out and its 95% confidence interval.
External validity of the ST6 with respect to the 6 minutes walk test (WT6)
时间窗: Day 0
The external validity with respect to the (6 minutes walk test) WT6 will be studied by calculating the Pearson correlation coefficient and its 95% confidence interval between the number of steps from the ST6 and the distance travelled in meters from the WT6.
次要结局
- External validity of the ST6 with respect to the cardiac stress test(Day 0)
- External validity of the ST6 with respect to the Oxygen saturation at rest.(Day 0)
- External validity of the ST6 with respect to the heart rate at maximum effort(Day 0)