NCT04086953Terminated
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
Source: ClinicalTrials.gov · Last updated 28 Mar 2025
Reason given: Inclusion difficulties (44/100 patients) despite a 24-month extension. The population often presents with 2 concomitant diseases.
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 29 Aug 2019
- Start date
- 20 Feb 2020
- Primary completion date
- 31 Jan 2024
- Lead sponsor
- University Hospital, Brest
- Diseases
- COPD
- NCT number
- NCT04086953
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject under resting oxygen therapy
Other illness
- 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.
Age
- Subject aged over 80 at the time of inclusion
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHRU Brest | Brest | France | Unknown status |
The registry text, word for word
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