Chronic Obstructive Pulmonary DiseaseTTLMNCT04086953
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
A study testing 6-minute walk test, Walk-Time Limit Tes and Incremental shuttle walk test in people with Chronic Obstructive Pulmonary Disease and Cardiovascular Insufficiency, run by University Hospital, Brest at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Cardiovascular Insufficiency
- What is being tested?
- 6-minute walk test, Walk-Time Limit Tes and Incremental shuttle walk test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2020to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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)
- Being tested
- 6-minute walk test, Walk-Time Limit Tes, Incremental shuttle walk test, Endurance shuttle walk test, Respiratory Functional Assessment
- Keywords
- Exercise Test, Walking Test, Chronic Disease, Endurance Time, Rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-minute walk testDiagnostic 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
Walk-Time Limit TesDiagnostic 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.
Incremental shuttle walk testDiagnostic 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.
Endurance shuttle walk testDiagnostic 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.
Respiratory Functional AssessmentDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Diagnostic Test: 6-minute walk test; Diagnostic Test: Walk-Time Limit Tes; Diagnostic Test: Incremental shuttle walk test; Diagnostic Test: Endurance shuttle walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (16)
Maximum speed measured at the ISWT
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
Measured: 0 day
Walking distance to 6-MWT
Realization of 6-MWT
Measured: 0 day
Number of steps by day (accelerometer)
wearing an accelerometer
Measured: 7 days
Maximum speed measured (4-meter walk test)
Realization of 4-meter walk test
Measured: 0 day
Oxygen consumption
VO2 ( in L/min)
Measured: 1 day
Dyspnea and leg fatigue during tests after WTLT
Assessment thanks to a score between 0 and 10 given by the patient before and after WTLT
Measured: 7 days
Forced expiratory volume per second
FEVS (in L)
Measured: 0 Day
Quadriceps strength
Manual dynamometer
Measured: 0 day
Score of motivation thanks to Behavourial Regulation and Exercise Questionnaire 2 (BREQ-2)
The answer to questions goes from 0 to 4 with 0 (not at all), 2 (sometimes it's true) and 4 (yes, absolutely).
Measured: 0 day
Following of the quality of life
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].
Measured: 0 day
carbon dioxide production
VCO2 ( in L/min)
Measured: 1 day
breathing frequency
RF (in breaths/min)
Measured: 1 day
heart rate
BPM (in beat per minute)
Measured: 1 day
Forced Vital Capacity
FVC (in L)
Measured: 0 day
Diffusing capacity for carbon monoxide
DLCO (in mL/min/mmHg)
Measured: 0 day
Total Lung Capacity
TLC (in L)
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start20 Feb 2020
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Why it stopped: Inclusion difficulties (44/100 patients) despite a 24-month extension. The population often presents with 2 concomitant diseases.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086953
- Sponsor's protocol ID
- 29BRC19.0134 TTLM
- Acronym
- TTLM
- Status last verified
- Mar 2025
- First submitted
- 29 Aug 2019
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04086953
- Acronym / sponsor ID
- TTLM / 29BRC19.0134 TTLM
- Keywords
- Exercise Test, Walking Test, Chronic Disease, Endurance Time, Rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion difficulties (44/100 patients) despite a 24-month extension. The population often presents with 2 concomitant diseases.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Respiratory Disease Group | Experimental | 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 AssessmentEach 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 | Experimental | Diagnostic Test: 6-minute walk test, Diagnostic Test: Walk-Time Limit Tes, Diagnostic Test: Incremental shuttle walk test, Diagnostic Test: Endurance shuttle walk testEach 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Chronic Respiratory Disease Group:
- Group cardiovascular diseases:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6-minute walk testThis 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 test | Cardiovascular diseases Group, Chronic Respiratory Disease Group |
| Walk-Time Limit TesEndurance 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. | Diagnostic test | Cardiovascular diseases Group, Chronic Respiratory Disease Group |
| Incremental shuttle walk testIncremental 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 test | Cardiovascular diseases Group, Chronic Respiratory Disease Group |
| Endurance shuttle walk testConstant 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 test | Cardiovascular diseases Group, Chronic Respiratory Disease Group |
| Respiratory Functional AssessmentForced 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. | Diagnostic test | Chronic Respiratory Disease Group |
Primary outcome
Endurance time
Time frame: 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
16 secondary outcomes
Maximum speed measured at the ISWT
Time frame: 0 day
Walking distance to 6-MWT
Time frame: 0 day
Number of steps by day (accelerometer)
Time frame: 7 days
Maximum speed measured (4-meter walk test)
Time frame: 0 day
Oxygen consumption
Time frame: 1 day
Dyspnea and leg fatigue during tests after WTLT
Time frame: 7 days
Forced expiratory volume per second
Time frame: 0 Day
Quadriceps strength
Time frame: 0 day
Score of motivation thanks to Behavourial Regulation and Exercise Questionnaire 2 (BREQ-2)
Time frame: 0 day
Following of the quality of life
Time frame: 0 day
carbon dioxide production
Time frame: 1 day
breathing frequency
Time frame: 1 day
heart rate
Time frame: 1 day
Forced Vital Capacity
Time frame: 0 day
Diffusing capacity for carbon monoxide
Time frame: 0 day
Total Lung Capacity
Time frame: 0 day
Results and safety
The study was stopped early (reason given: Inclusion difficulties (44/100 patients) despite a 24-month extension. The population often presents with 2 concomitant diseases.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6-minute walk test, Walk-Time Limit Tes and Incremental shuttle walk test in people with Chronic Obstructive Pulmonary Disease and Cardiovascular Insufficiency, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inclusion difficulties (44/100 patients) despite a 24-month extension. The population often presents with 2 concomitant diseases.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endurance time (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.