Clinical trial NCT01904929: The 400m-walk-test for Stable Coronary Patients
Official title: Evaluation of the Psychometric Properties of the 400m-walk-test at a Self-selected Speed (400m WT) for Stable Coronary Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Coronary
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-07-22
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


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.
* 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).

Primary outcomes:
measure: Measurement of intra-class correlation coefficient (ICC)
timeFrame: 3 days
Secondary outcomes:
measure: A variance analysis (ANOVA)
timeFrame: 3 days
measure: Univariate analysis
timeFrame: 3 days
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon
Study officials:
References: