The 400m-walk-test for Stable Coronary Patients

Not Applicable

Completed

• Conditions: Chronic Coronary
• Interventions: Other: Walk-tests

• Registration Number: NCT01904929
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2013-07-17
• Study First Posted: 2013-07-22
• Study Start: 2013-11
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reconditioning in the effort	Walk-tests	-

Primary Outcome Measures

Name	Time	Method
Measurement of intra-class correlation coefficient (ICC)	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 Outcome Measures

Name	Time	Method
Univariate analysis	3 days	To search for potential relationships between the maximum heart rate and the following variables: age, height, weight, BMI, HRrest (resting heart rate), FC6mn (heart rate at 6 minutes), T6mn (T=6 minutes), FCT200, TMR200 (Test of fast walking of 200m), and TML400. To select the variables of interest, we will use a stepwise method using algorithms available in the NCSS 2004 software (Statistical software).
A variance analysis (ANOVA)	3 days	To determine differences between the different measures performed in the VO2 tests. If a significant difference is found, a post-hoc LSD(Least Significant Difference)test types will be conducted to classify the variables.

Trial Locations

Locations (1)

CHU Dijon; 🇫🇷 Dijon, France