The 400m-walk-test for Stable Coronary Patients (TML 400 m)
|ClinicalTrials.gov Identifier: NCT01904929|
Recruitment Status : Unknown
Verified July 2013 by Centre Hospitalier Universitaire Dijon.
Recruitment status was: Recruiting
First Posted : July 22, 2013
Last Update Posted : July 22, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Coronary||Other: Walk-tests||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Psychometric Properties of the 400m-walk-test at a Self-selected Speed (400m WT) for Stable Coronary Patients|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||June 2015|
|Experimental: Reconditioning in the effort||
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.
- Measurement of intra-class correlation coefficient (ICC) [ Time Frame: 3 days ]
- 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.
- A variance analysis (ANOVA) [ Time Frame: 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.
- Univariate analysis [ Time Frame: 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904929
|Dijon, France, 21079|
|Contact: Jean-Marie CASILLAS 0380293815 email@example.com|