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

Chronic Obstructive Pulmonary Disease Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04086953
• Other study ID #: 29BRC19.0134 TTLM
• Status: Terminated
• Phase: N/A
• Start date: February 20, 2020
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Insufficiency
• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Diagnostic Test:
• 6-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
• Walk-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 shuttle walk 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 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 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.

Locations

Country	Name	City	State
France	CHRU Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 weeks
Secondary	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	0 day
Secondary	Walking distance to 6-MWT	Realization of 6-MWT	0 day
Secondary	Number of steps by day (accelerometer)	wearing an accelerometer	7 days
Secondary	Maximum speed measured (4-meter walk test)	Realization of 4-meter walk test	0 day
Secondary	Oxygen consumption	VO2 ( in L/min)	1 day
Secondary	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	7 days
Secondary	Forced expiratory volume per second	FEVS (in L)	0 Day
Secondary	Quadriceps strength	Manual dynamometer	0 day
Secondary	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).	0 day
Secondary	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].	0 day
Secondary	carbon dioxide production	VCO2 ( in L/min)	1 day
Secondary	breathing frequency	RF (in breaths/min)	1 day
Secondary	heart rate	BPM (in beat per minute)	1 day
Secondary	Forced Vital Capacity	FVC (in L)	0 day
Secondary	Diffusing capacity for carbon monoxide	DLCO (in mL/min/mmHg)	0 day
Secondary	Total Lung Capacity	TLC (in L)	0 day