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临床试验/NCT01904929
NCT01904929已完成不适用

Evaluation of the Psychometric Properties of the 400m-walk-test at a Self-selected Speed (400m WT) for Stable Coronary Patients

Centre Hospitalier Universitaire Dijon2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Measurement of intra-class correlation coefficient (ICC)

研究概览

简要总结

The objective of this project is to clarify and improve the efficiency of the standardized walk-test in Cardiovascular Rehabilitation. The psycho-metric properties of the 400m walk test at a self-selected speed will be evaluated. Such tests, made at a self-selected ("comfortable", "free") speed particularly assess the endurance capacities. The results of the physiological measurements during the tests will be compared with those of TM6min of Test of Fast Walking of 200m (TMR200m) and a maximal treadmill exercise. Stable coronary patients, aged over 55 years old, will be included.

This study should permit a simplification and a better understanding of the clinical-use of walk tests. In the future, two kinds of tests might be proposed with different distances, 1- 200m-fast-walking-test aimed to evaluate the performance closed to the maximum capacity, 2- self-selected-walk-test on a doubled distance (400m) aimed to evaluate the aerobic capacities of the adaptation of the body in response to effort.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

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

入选标准

  • Patient received enlightened information on research.
  • Patient affiliated to healthcare insurance.
  • Patients who agreed to participate in the study.
  • Patient male or female aged 55 or more.
  • Chronic coronary patient who completed his rehabilitation program.
  • Patient able to understand simple orders.
  • Indication of outpatient rehabilitation in coronary angioplasty + stenting, surgical coronary revascularization (coronary artery bypass), acute coronary syndrome (STEMI or NO STEMI) or stable angina suites.

排除标准

  • Patient under guardianship or tutelage
  • Arrhythmia or pace maker (making criterion heart rate unusable).
  • Congestive heart failure with left ventricular ejection fraction <45% measured by trans-thoracic echocardiography according to Simpson's method or assay plasma N-terminal pro-brain natriuretic peptide (NT-pro-BNP-3) times the values used in healthy subjects by the analytical laboratory of the University Hospital of Dijon.
  • Severe obstructive cardiomyopathy.
  • Aortic valve.
  • Thrombus intra cavitary.
  • Severe pulmonary hypertension (> 70 mm Hg).
  • History of venous thromboembolism in the last 3 months.
  • Heart Transplantation.
  • Chronic motor impairments associated with neurological (e.g. sequelae of stroke, impaired balance and coordination) or musculoskeletal origin (e.g., osteoarthritis, osteoarthritis), because the secondary functional impairment will limit the ability to work predominantly in relation to the adaptation to stress.
  • Severe medical disorder associated to a significantly alteration of the functional capacity (respiratory failure, metabolic disorders such as non-stabilized progressive renal failure) and involving the vital prognosis in the short or medium term (neoplasIC pathology progressive, systemic disease, non-stabilized).

结局指标

主要结局

Measurement of intra-class correlation coefficient (ICC)

时间窗: 3 days

Measurement between: * 1\) The Maximal consumption of oxygen (VO2) uptake during the 400m-walk-test (TML400m) and the VO2 value at the first aerobic threshold measured during graded maximal exercise on treadmill. * 2\) the heart rate during TML400 and the heart rate value at the first aerobic threshold measured during graded maximal exercise on treadmill. These ICC will be also assessed, during a 6-minute-walk-test and a 200m-fast walk test compared to the maximal graded test.

次要结局

  • Univariate analysis(3 days)
  • A variance analysis (ANOVA)(3 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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