CClinicalTrials.gg
CompletedNCT01904929TML 400 mUpdated Feb 28, 2024

The 400m-walk-test for Stable Coronary Patients

An interventional study of Walk-tests in Chronic Coronary, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Centre Hospitalier Universitaire Dijon · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
55 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Coronary
03

In context

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Reconditioning in the effort

    Other: Walk-tests

Interventions

  • OtherWalk-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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 days

Secondary outcomes

  1. 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.

    Time frame: 3 days

  2. 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).

    Time frame: 3 days

07

Study locations

1 site
  • CHU Dijon
    Dijon, 21079, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01904929
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Jul 22, 2013
Start date
Nov 2013
Primary completion
Apr 2016
Completion
Apr 2016
Last update
Feb 28, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion