Back to resultsValidation 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)
Primary Purpose
Chronic Obstructive Pulmonary Disease, Cardiovascular Insufficiency
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
6-minute walk test
Walk-Time Limit Tes
Incremental shuttle walk test
Endurance shuttle walk test
Respiratory Functional Assessment
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease focused on measuring Exercise Test, Walking Test, Chronic Disease, Endurance Time, Rehabilitation
Eligibility Criteria
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.
Sites / Locations
- CHRU BrestRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Chronic Respiratory Disease Group
Cardiovascular diseases Group
Arm 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
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)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Walking distance to 6-MWT
Realization of 6-MWT
Number of steps by day (accelerometer)
wearing an accelerometer
Maximum speed measured (4-meter walk test)
Realization of 4-meter walk test
Oxygen consumption
VO2 ( in L/min)
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
Forced expiratory volume per second
FEVS (in L)
Quadriceps strength
Manual dynamometer
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).
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].
carbon dioxide production
VCO2 ( in L/min)
breathing frequency
RF (in breaths/min)
heart rate
BPM (in beat per minute)
Forced Vital Capacity
FVC (in L)
Diffusing capacity for carbon monoxide
DLCO (in mL/min/mmHg)
Total Lung Capacity
TLC (in L)
Full Information
NCT ID
NCT04086953
First Posted
August 29, 2019
Last Updated
February 8, 2023
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT04086953
Brief 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
Acronym
TTLM
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
February 20, 2024 (Anticipated)
Study Completion Date
March 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Cardiovascular Insufficiency
Keywords
Exercise Test, Walking Test, Chronic Disease, Endurance Time, Rehabilitation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chronic Respiratory Disease Group
Arm Type
Experimental
Arm 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
Arm Title
Cardiovascular diseases Group
Arm Type
Experimental
Arm 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)
Intervention Type
Diagnostic Test
Intervention Name(s)
6-minute walk test
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Walk-Time Limit Tes
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Incremental shuttle walk test
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Endurance shuttle walk test
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Respiratory Functional Assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Endurance time
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Maximum speed measured at the ISWT
Description
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
Time Frame
0 day
Title
Walking distance to 6-MWT
Description
Realization of 6-MWT
Time Frame
0 day
Title
Number of steps by day (accelerometer)
Description
wearing an accelerometer
Time Frame
7 days
Title
Maximum speed measured (4-meter walk test)
Description
Realization of 4-meter walk test
Time Frame
0 day
Title
Oxygen consumption
Description
VO2 ( in L/min)
Time Frame
1 day
Title
Dyspnea and leg fatigue during tests after WTLT
Description
Assessment thanks to a score between 0 and 10 given by the patient before and after WTLT
Time Frame
7 days
Title
Forced expiratory volume per second
Description
FEVS (in L)
Time Frame
0 Day
Title
Quadriceps strength
Description
Manual dynamometer
Time Frame
0 day
Title
Score of motivation thanks to Behavourial Regulation and Exercise Questionnaire 2 (BREQ-2)
Description
The answer to questions goes from 0 to 4 with 0 (not at all), 2 (sometimes it's true) and 4 (yes, absolutely).
Time Frame
0 day
Title
Following of the quality of life
Description
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].
Time Frame
0 day
Title
carbon dioxide production
Description
VCO2 ( in L/min)
Time Frame
1 day
Title
breathing frequency
Description
RF (in breaths/min)
Time Frame
1 day
Title
heart rate
Description
BPM (in beat per minute)
Time Frame
1 day
Title
Forced Vital Capacity
Description
FVC (in L)
Time Frame
0 day
Title
Diffusing capacity for carbon monoxide
Description
DLCO (in mL/min/mmHg)
Time Frame
0 day
Title
Total Lung Capacity
Description
TLC (in L)
Time Frame
0 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Agnès GIROUX-METGES
Phone
2 98 34 73 66
Ext
+33
Email
marie-agnes.metges@chu-brest.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Baptiste CHEHERE
Phone
6 08 32 07 62
Ext
+33
Email
baptiste.chehere@univ-brest.fr
Facility Information:
Facility Name
CHRU Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Agnès GIROUX-METGES, PU-PH
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available beginning three years and ending fifteen years following the final study report completion
IPD Sharing 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.
Learn more about this trial
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
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