Validation of a Walk-Time Limit Test (WTLT) Derived from the 6-Minute Walk Test (6-MWT) in Patients with Chronic Cardiovascular or Respiratory Diseases
NCT ID: NCT04086953
Last Updated: 2025-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
44 participants
INTERVENTIONAL
2020-02-20
2024-01-31
Brief Summary
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Among the tests (6-MWT, incremental test, ...), the literature seems to indicate that endurance time is the most responsive parameter for detecting and quantifying changes in exercise capacity following a rehabilitation program. Although its clinical interest is undeniable, the endurance shuttle walking test is rarely used because it requires the prior performance of two incremental shuttle walking tests to determine the walking speed imposed on the patient.
In this protocol, we propose to test a Walk-Time Limit Test (WTLT) derived from the 6-minute walk test (6-MWT) and based on the average walking speed achieved in this test commonly used in the follow-up of patients with chronic diseases.
TTLM validation would improve the functional assessment of patients with chronic diseases while limiting the number of exercise tests.
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Detailed Description
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During the first visit, the subject will realize two 6-MWT and a cardiopulmonary exercise test on ergocycle with the measure of cardiorespiratory parameters. We will evaluate the physical activity during daily life using an accelerometer and we will use several questionnaires to measure the quality of life, the motivation to physical activities and symptoms.
During the second visit, the subject will realize a 4-meter walk test, two incremental shuttle walk tests (ISWT), an endurance shuttle walk test (ESWT) and a test with dynamometer to measure the quadriceps strength.
During the third and fourth visits, the subject realize two or three endurance walking tests (Walk-Time Limit Test - WTLT) at a walking speed equivalent to the mean speed realize during the better 6MWT (visit 1)
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Chronic Respiratory Disease Group
Each patient receive the same intervention : 4 visits with different exercise tests.
Visit 1: Inclusion Visit, Functional Assessment and TTLM Speed Determination (6-minute walk test x2, cardiopulmonary exercise testing on ergocycle, questionnaires and accelerometer)
Visit 2 : Functional Evaluation and Shuttle Tests (ISWT, ESWT, Speed tests on 4m, Quadriceps muscle strength)
Visit 3 : Feasibility of the WTLT (WTLT x2 or 3)
Visit 4 : Reproducibility of the WTLT (WTLT x2) Specific measures for COPD subjects : Respiratory Functional Assessment and Dyspnea questionnaire
6-minute walk test
This test is carried out in a 30-meter long walking corridor with two cones placed at the ends of the course and representing the turning zones
Walk-Time Limit Tes
Endurance test where the patient must walk at the same speed during the whole test (time limit). The test is carried out in a corridor 10 meter long.
Incremental shuttle walk test
Incremental walking test suitable for patients with chronic respiratory diseases. To perform this test, it is necessary to have a 10-meter walking corridor. The walking speed is dictated by a sound signal previously recorded. Every minute, the time between each beep is decreased and therefore the walking speed increased. The increment is 0.17m / sec every minute. Shifting to a higher speed is indicated by a triple beep. At most, the ISWT includes 12 speed levels.
Endurance shuttle walk test
Constant load endurance running test performed on the same 10 meter run as the ISWT.
The patient is walking at a constant speed imposed by the audio beeps as for the ISWT. The objective of this test is to maintain the imposed walking speed as long as possible. The speed is calculated from the ISWT.
Respiratory Functional Assessment
Forced vital capacity, total lung capacity, forced expiratory volume measured during the first second of forced expiration, and carbon monoxide diffusion capacity will be measured by plethysmographic examination and spirometry.
Cardiovascular diseases Group
Each patient receive the same intervention : 4 visits with different tests.
Visit 1: Inclusion Visit, Functional Assessment and TTLM Speed Determination (6-minute walk test x2, cardiopulmonary exercise testing on ergocycle,, questionnaires and accelerometer)
Visit 2 : Functional Evaluation and Shuttle Tests (ISWT, ESWT, Speed tests on 4m, Quadriceps muscle strength)
Visit 3 : Feasibility of the WTLT (WTLT x2 or 3)
Visit 4 : Reproducibility of the WTLT (WTLT x2)
6-minute walk test
This test is carried out in a 30-meter long walking corridor with two cones placed at the ends of the course and representing the turning zones
Walk-Time Limit Tes
Endurance test where the patient must walk at the same speed during the whole test (time limit). The test is carried out in a corridor 10 meter long.
Incremental shuttle walk test
Incremental walking test suitable for patients with chronic respiratory diseases. To perform this test, it is necessary to have a 10-meter walking corridor. The walking speed is dictated by a sound signal previously recorded. Every minute, the time between each beep is decreased and therefore the walking speed increased. The increment is 0.17m / sec every minute. Shifting to a higher speed is indicated by a triple beep. At most, the ISWT includes 12 speed levels.
Endurance shuttle walk test
Constant load endurance running test performed on the same 10 meter run as the ISWT.
The patient is walking at a constant speed imposed by the audio beeps as for the ISWT. The objective of this test is to maintain the imposed walking speed as long as possible. The speed is calculated from the ISWT.
Interventions
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6-minute walk test
This test is carried out in a 30-meter long walking corridor with two cones placed at the ends of the course and representing the turning zones
Walk-Time Limit Tes
Endurance test where the patient must walk at the same speed during the whole test (time limit). The test is carried out in a corridor 10 meter long.
Incremental shuttle walk test
Incremental walking test suitable for patients with chronic respiratory diseases. To perform this test, it is necessary to have a 10-meter walking corridor. The walking speed is dictated by a sound signal previously recorded. Every minute, the time between each beep is decreased and therefore the walking speed increased. The increment is 0.17m / sec every minute. Shifting to a higher speed is indicated by a triple beep. At most, the ISWT includes 12 speed levels.
Endurance shuttle walk test
Constant load endurance running test performed on the same 10 meter run as the ISWT.
The patient is walking at a constant speed imposed by the audio beeps as for the ISWT. The objective of this test is to maintain the imposed walking speed as long as possible. The speed is calculated from the ISWT.
Respiratory Functional Assessment
Forced vital capacity, total lung capacity, forced expiratory volume measured during the first second of forced expiration, and carbon monoxide diffusion capacity will be measured by plethysmographic examination and spirometry.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of COPD with FEV1 corresponding to stages GOLD II or III (50-80% predicted or 30-50% predicted, respectively).
* Patient's agreement
* Being older than 18
* Stable treatment for 3 months
* Subjects affiliated with social security
* Group cardiovascular diseases:
* Diagnosis of heart failure or stable coronary artery disease with NYHA Class II stage.
* Patient's agreement
* Being older than 18
* Stable treatment for 3 months
* Subjects affiliated with social security
Exclusion Criteria
* Presence of muscle, joint and / or neurological comorbidities affecting motor skills and test performance.
* Refusal of the patient
* Subject under guardianship or curatorship
* Subject aged over 80 at the time of inclusion
* Realization of a rehabilitation program during the study period
* Subject under resting oxygen therapy
* Diagnosis of heart failure, coronary artery disease or any cardiovascular pathology that required surgery.
* Diagnosis of an associated chronic respiratory disease, such as asthma, pulmonary arterial hypertension or interstitial lung disease.
18 Years
80 Years
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Locations
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CHRU Brest
Brest, France, France
Countries
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Other Identifiers
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29BRC19.0134 TTLM
Identifier Type: -
Identifier Source: org_study_id
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