The 400m-walk-test for Stable Coronary Patients (TML 400 m)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Coronary
• Intervention / Treatment: Other: Walk-tests

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • CHU Dijon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Reconditioning in the effort

Other: Walk-tests; Patients will make a 6-minute-walk-test, the 400m-walk-test and a 200m-fast walk test. These first 2 tests (TM6min and TML400m) will be made in an order determined by randomization. This series of test will be repeated 72 hours later for the study reproducibility. It will be followed by a phase of rest of 15 min and a test of effort on travelator, according to the protocol of " modified Bruce " in moderation of portable VO2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of intra-class correlation coefficient (ICC)	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.	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A variance analysis (ANOVA)	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.	3 days
Univariate analysis	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).	3 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2013
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: July 8, 2013
• First Submitted That Met QC Criteria: July 17, 2013
• First Posted (Estimated): July 22, 2013

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CASILLAS TML 400m 2013