Chronic CoronaryTML 400 mNCT01904929
The 400m-walk-test for Stable Coronary Patients
A study testing Walk-tests in people with Chronic Coronary, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Chronic Coronary
- What is being tested?
- Walk-tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Coronary
- Being tested
- Walk-tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk-testsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Reconditioning in the effort | Experimental | Not described Receives: Other: Walk-tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Secondary outcomes (2)
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.
Measured: 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).
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic CoronaryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904929
- Sponsor's protocol ID
- CASILLAS TML 400m 2013
- Acronym
- TML 400 m
- Status last verified
- Feb 2024
- First submitted
- 8 Jul 2013
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Psychometric Properties of the 400m-walk-test at a Self-selected Speed (400m WT) for Stable Coronary Patients
- ClinicalTrials.gov ID
- NCT01904929
- Acronym / sponsor ID
- TML 400 m / CASILLAS TML 400m 2013
- Conditions
- Chronic Coronary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reconditioning in the effort | Experimental | Other: Walk-tests |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walk-testsPatients 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. | Other | Reconditioning in the effort |
Primary outcome
Measurement of intra-class correlation coefficient (ICC)
Time frame: 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.
2 secondary outcomes
A variance analysis (ANOVA)
Time frame: 3 days
Univariate analysis
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walk-tests in people with Chronic Coronary, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of intra-class correlation coefficient (ICC) (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.