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Clinical Trials/NCT01904929
NCT01904929
Completed
Not Applicable

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

Centre Hospitalier Universitaire Dijon1 site in 1 country80 target enrollmentNovember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Coronary
Sponsor
Centre Hospitalier Universitaire Dijon
Enrollment
80
Locations
1
Primary Endpoint
Measurement of intra-class correlation coefficient (ICC)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
April 2016
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Measurement of intra-class correlation coefficient (ICC)

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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