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

Not Applicable

Terminated

• Conditions: Chronic Obstructive Pulmonary Disease; Cardiovascular Insufficiency
• Interventions: Diagnostic Test: 6-minute walk test; Diagnostic Test: Walk-Time Limit Tes; Diagnostic Test: Incremental shuttle walk test; Diagnostic Test: Endurance shuttle walk test; Diagnostic Test: Respiratory Functional Assessment

• Registration Number: NCT04086953
• Lead Sponsor: University Hospital, Brest

Brief Summary

Many exercise tests are commonly used to evaluate the changes of exercise tolerance following rehabilitation programs in patients with chronic respiratory diseases.

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.

Detailed Description

Each patient will perform 4 visits over a period of 4-week. Fifty subjects with COPD and fifty subjects with heart failure will be recruited for the same protocol.

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)

Study Timeline

• Study First Submitted: 2019-08-29
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-12
• Study Start: 2020-02-20
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Chronic Respiratory Disease Group:

  • 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

• Any medical contraindications to the practice of a suitable physical activity
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chronic Respiratory Disease Group	Endurance shuttle walk test	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
Cardiovascular diseases Group	Walk-Time Limit Tes	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)
Cardiovascular diseases Group	Incremental shuttle walk test	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)
Chronic Respiratory Disease Group	Incremental shuttle walk test	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
Chronic Respiratory Disease Group	6-minute walk test	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
Chronic Respiratory Disease Group	Walk-Time Limit Tes	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
Chronic Respiratory Disease Group	Respiratory Functional Assessment	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
Cardiovascular diseases Group	6-minute walk test	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)
Cardiovascular diseases Group	Endurance shuttle walk test	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)

Primary Outcome Measures

Name	Time	Method
Endurance time	4 weeks	The patient walks at the same speed during the entire test in a corridor 10 meters long around studs placed at a distance of 9m

Secondary Outcome Measures

Name	Time	Method
Score of motivation thanks to Behavourial Regulation and Exercise Questionnaire 2 (BREQ-2)	0 day	The answer to questions goes from 0 to 4 with 0 (not at all), 2 (sometimes it's true) and 4 (yes, absolutely).
Walking distance to 6-MWT	0 day	Realization of 6-MWT
Following of the quality of life	0 day	The Short Form 36 (SF36) is used to evaluate the quality of life. The SF36 scale includes 36 items divided into 8 dimensions (physical functioning, role limitations related to physical health, physical pain, general health, vitality \[energy / fatigue\].
Number of steps by day (accelerometer)	7 days	wearing an accelerometer
Forced expiratory volume per second	0 Day	FEVS (in L)
Forced Vital Capacity	0 day	FVC (in L)
Total Lung Capacity	0 day	TLC (in L)
Dyspnea and leg fatigue during tests after WTLT	7 days	Assessment thanks to a score between 0 and 10 given by the patient before and after WTLT
heart rate	1 day	BPM (in beat per minute)
Maximum speed measured at the ISWT	0 day	Realization of ISWT (Incremental shuttle walk test) : 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. At the maximum, the ISWT has 12 speed levels ranging from 1.8 km/h (start of test) to approximately 8.5 km/h
carbon dioxide production	1 day	VCO2 ( in L/min)
Maximum speed measured (4-meter walk test)	0 day	Realization of 4-meter walk test
Oxygen consumption	1 day	VO2 ( in L/min)
Quadriceps strength	0 day	Manual dynamometer
breathing frequency	1 day	RF (in breaths/min)
Diffusing capacity for carbon monoxide	0 day	DLCO (in mL/min/mmHg)

Trial Locations

Locations (1)

CHRU Brest; 🇫🇷 Brest, France