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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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04086953
Acronym
TTLM
Enrollment
44
Registered
2019-09-12
Start date
2020-02-20
Completion date
2024-01-31
Last updated
2025-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Insufficiency, Chronic Obstructive Pulmonary Disease

Keywords

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

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)

Interventions

DIAGNOSTIC_TEST6-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

DIAGNOSTIC_TESTWalk-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 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.

DIAGNOSTIC_TESTEndurance 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.

DIAGNOSTIC_TESTRespiratory 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.

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Endurance time4 weeksThe 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

MeasureTime frameDescription
Maximum speed measured (4-meter walk test)0 dayRealization of 4-meter walk test
Maximum speed measured at the ISWT0 dayRealization 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
Walking distance to 6-MWT0 dayRealization of 6-MWT
Oxygen consumption1 dayVO2 ( in L/min)
Dyspnea and leg fatigue during tests after WTLT7 daysAssessment thanks to a score between 0 and 10 given by the patient before and after WTLT
Forced expiratory volume per second0 DayFEVS (in L)
Quadriceps strength0 dayManual dynamometer
Number of steps by day (accelerometer)7 dayswearing an accelerometer
Following of the quality of life0 dayThe 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 \[energy / fatigue\].
carbon dioxide production1 dayVCO2 ( in L/min)
breathing frequency1 dayRF (in breaths/min)
heart rate1 dayBPM (in beat per minute)
Forced Vital Capacity0 dayFVC (in L)
Diffusing capacity for carbon monoxide0 dayDLCO (in mL/min/mmHg)
Total Lung Capacity0 dayTLC (in L)
Score of motivation thanks to Behavourial Regulation and Exercise Questionnaire 2 (BREQ-2)0 dayThe answer to questions goes from 0 to 4 with 0 (not at all), 2 (sometimes it's true) and 4 (yes, absolutely).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026