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

NCT04086953 | Terminated

• 1 other identifier: 29BRC19.0134 TTLM
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Cardiovascular Insufficiency

Keywords

Exercise Test; Walking Test; Chronic Disease; Endurance Time; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Endurance time

  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

  4 weeks

Secondary Outcomes (16)

• Maximum speed measured at the ISWT

  0 day

• Walking distance to 6-MWT

  0 day

• Number of steps by day (accelerometer)

  7 days

• Maximum speed measured (4-meter walk test)

  0 day

• Oxygen consumption

  1 day

Study Arms (2)

Chronic Respiratory Disease Group

EXPERIMENTAL

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

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

Cardiovascular diseases Group

EXPERIMENTAL

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)

Diagnostic Test: 6-minute walk test; Diagnostic Test: Walk-Time Limit Tes; Diagnostic Test: Incremental shuttle walk test; Diagnostic Test: Endurance shuttle walk test

Interventions

6-minute walk test DIAGNOSTIC_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

Cardiovascular diseases Group; Chronic Respiratory Disease Group

Walk-Time Limit Tes DIAGNOSTIC_TEST

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.

Cardiovascular diseases Group; Chronic Respiratory Disease Group

Incremental shuttle walk test DIAGNOSTIC_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.

Cardiovascular diseases Group; Chronic Respiratory Disease Group

Endurance shuttle walk test DIAGNOSTIC_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.

Cardiovascular diseases Group; Chronic Respiratory Disease Group

Respiratory Functional Assessment DIAGNOSTIC_TEST

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.

Chronic Respiratory Disease Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU Brest

Brest, France, 29200, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Chronic Disease

Interventions

Walk Test

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Test; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 12, 2019
• Study Start: February 20, 2020
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)