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 (TTLM)

Regional University Hospital Center (CHRU)

Status: Terminated

Conditions: Cardiovascular Insufficiency; Chronic Obstructive Pulmonary Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04086953

29BRC19.0134 TTLM

Details and patient eligibility

About

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.

Full 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)

Enrollment: 44 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Chronic Respiratory Disease Group

Experimental group

Description:

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

Treatment:

Diagnostic Test: Incremental shuttle walk test

Diagnostic Test: Respiratory Functional Assessment

Diagnostic Test: Walk-Time Limit Tes

Diagnostic Test: 6-minute walk test

Diagnostic Test: Endurance shuttle walk test

Cardiovascular diseases Group

Experimental group

Description:

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)

Treatment:

Diagnostic Test: Incremental shuttle walk test

Diagnostic Test: Walk-Time Limit Tes

Diagnostic Test: 6-minute walk test

Diagnostic Test: Endurance shuttle walk test