Exercise Tolerance and Lower-limb Muscle Power in Patients With Chronic Respiratory Disease (VTEP)

Assessment of Exercise Tolerance and Lower-limb Muscle Power in Patients With Chronic Respiratory Disease: a Multicenter Validity Study

The aim of this study is to validate the six minute Stepper Test (6MST) and the 5-repetition chair lift test (5STS) as measures of exercise tolerance and muscle power, respectively, in patients with chronic respiratory disease.

As the reproducibility of the tests has been studied and validated in previous studies, the objective is to investigate the validity of the 6MST and 5STS in comparison with their respective gold standards.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Disease, Chronic Obstructive; Pulmonary Fibrosis
• Intervention / Treatment: Other: Functional capacity tests

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie Paule LEBITASY, MD; Phone Number: +33320225269; Email: Lebitasy.Marie-Paule@ghicl.net
• Study Contact Backup: Name: William's VAN DEN BERGHE; Phone Number: +33320225731; Email: VanDenBerghe.Williams@ghicl.net

Study Locations

• Canada
  • Québec, Canada, G1V 4G5
    • Centre de Pneumologie Institut universitaire de cardiologie et de pneumologie de Québec
    • Contact: François MALTAIS; Email: Francois.Maltais@fmed.ulaval.ca
• France
  • Lomme, France, 59160
    • Hôpital Saint-Philibert (GHICL)
    • Contact: Arnaud CHAMBELLAN; Email: Chambellan.Arnaud@ghicl.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 40 and over
• With a diagnosis of chronic obstructive pulmonary disease (GOLD II - IV) or pulmonary fibrosis (>6 months).
• Able to understand and follow verbal instructions during tests
• Affiliated with a social security scheme
• Willing to participate in the study

Exclusion Criteria:

• Have a neurological, cardiovascular or balance disorder that could impair test performance.
• Having undergone respiratory rehabilitation within the last year.
• With unstable disease (recent exacerbation < 4 weeks).
• Pregnant and/or breast-feeding women
• Patients under guardianship or curatorship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with a diagnosis of COPD (GOLD II- V) or pulmonary fibrosis (>6 months).	Other: Functional capacity tests; Maximal effort test on cycloergometer (1st visit) Maximal effort test, 6-minute stepper test, 6-minute walk test, 5-times sit to stand test. A minimum rest period of 15 minutes must be observed between these tests (2nd Visit)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen consumption	Oxygen consumption will be measured using the Cortex Metamax 3B (MM3B) automated gas analysis system. Maximum oxygen consumption obtained at the end of six minutes step test (6MST) and compared with the maximum oxygen consumption obtained in the maximum cardiorespiratory exercise test performed on a cycloergometer (gold standard for measuring exercise tolerance). The 6MST aims at measuring the number of steps performed on a stepper in 6 minutes. A step is defined as a single complete movement of raising one foot and putting it down. The stepper is placed on the ground facing a wall to allow patients to maintain their balance by placing their fingers on the wall. The step height is set at 20 cm. Before starting the test, patients get accustomed to the stepper for 2 minutes. The protocol include a 3-minute rest period and a 6-minute stepping period.	19 days
Lower limb muscle power after Five Times Sit to Stand Test (5STS,) calculated by the ratio between STS mean velocity and STS mean force	The 5XSTS scoring is based on the amount of time (to the nearest decimal in seconds) a patient is able to transfer from a seated to a standing position and back to sitting five times. The lower the time to complete the test the better the outcome of the test.The Lower limb muscle power will be calculated by the ratio between STS mean velocity and STS mean force according to the following equation : Power 5STS = body mass x 0,9 x g x (Height x 0,5 - chair height)/(time 5STS x 0,1) *g = 9,81 m/s, body mass in kg et Height in meters.	19 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate after 6MST	The 6MST aims at measuring the number of steps performed on a stepper in 6 minutes. A step is defined as a single complete movement of raising one foot and putting it down. The stepper is placed on the ground facing a wall to allow patients to maintain their balance by placing their fingers on the wall. The step height is set at 20 cm. Before starting the test, patients get accustomed to the stepper for 2 minutes. The protocol include a 3-minute rest period and a 6-minute stepping period.This measurement will be compared with those measured during a 6-minute walk test (gold standard for field tests) and a maximal cardiorespiratory exercise test on a cycloergometer (gold standard for laboratory tests)	19 days
Oxygen saturation after 6MST	Oxygen saturation will be measured using the Cortex Metamax 3B (MM3B) automated gas analysis system. The 6MST aims at measuring the number of steps performed on a stepper in 6 minutes. A step is defined as a single complete movement of raising one foot and putting it down. The stepper is placed on the ground facing a wall to allow patients to maintain their balance by placing their fingers on the wall. The step height is set at 20 cm. Before starting the test, patients get accustomed to the stepper for 2 minutes. The protocol include a 3-minute rest period and a 6-minute stepping period.This measurement will be compared with those measured during a 6-minute walk test (gold standard for field tests) and a maximal cardiorespiratory exercise test on a cycloergometer (gold standard for laboratory tests)	19 days
Minute ventilation after 6MST	Minute ventilation will be measured using the Cortex Metamax 3B (MM3B) automated gas analysis system. The 6MST aims at measuring the number of steps performed on a stepper in 6 minutes. A step is defined as a single complete movement of raising one foot and putting it down. The stepper is placed on the ground facing a wall to allow patients to maintain their balance by placing their fingers on the wall. The step height is set at 20 cm. Before starting the test, patients get accustomed to the stepper for 2 minutes. The protocol include a 3-minute rest period and a 6-minute stepping period.This measurement will be compared with those measured during a 6-minute walk test (gold standard for field tests) and a maximal cardiorespiratory exercise test on a cycloergometer (gold standard for laboratory tests)	19 days
Respiratory rate after 6MST	Respiratory rate will be measured using the Cortex Metamax 3B (MM3B) automated gas analysis system. The 6MST aims at measuring the number of steps performed on a stepper in 6 minutes. A step is defined as a single complete movement of raising one foot and putting it down. The stepper is placed on the ground facing a wall to allow patients to maintain their balance by placing their fingers on the wall. The step height is set at 20 cm. Before starting the test, patients get accustomed to the stepper for 2 minutes. The protocol include a 3-minute rest period and a 6-minute stepping period.This measurement will be compared with those measured during a 6-minute walk test (gold standard for field tests) and a maximal cardiorespiratory exercise test on a cycloergometer (gold standard for laboratory tests)	19 days
Leg fatigue after 6MST measured by the modified Borg scale	The modified Borg scale is a numerical scale that allows individuals to subjectively rate their level of exertion during exercise. The scale ranges from 0 to 10, where 0 means "no exertion at all" and 10 means maximal exertion.	19 days
Maximum effort test after 6MST	The patient will perform the test on a cycloergometer and will be connected to a portable gas exchange analyzer via a face mask (Metamax 3B Cortex). After warming up, intensity will be increased by 10-15 W.min-1 until maximal effort is achieved, in line with recommendations. Participants will be asked to maintain a pedaling frequency of 60 ± 5 rpm. Blood pressure will be measured at rest, every 2 min during exercise and during 5 min of recovery.	19 days
Lower limb muscle power after 5STS test	A force platform (Multicomponent force plate, Kistler) will be positioned under the participant's feet. The muscular power developed by the lower limbs during the 5STS will be measured using this platform and the value will be compared with that calculated by the reference equation available in the literature.	19 days

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Collaborators: University of Lille Nord de France
• Investigators: Principal Investigator: Arnaud CHAMBELLAN, MD, Hôpital Saint Philibert, GHICL

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Estimated): November 9, 2023

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Chronic obstructive pulmonary disease (COPD); Pulmonary Fibrosis; Six minutes stepper test (6MST); 5-times sit to stand test (5STS)
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Lung Diseases, Obstructive; Lung Diseases, Interstitial; Chronic Disease; Fibrosis; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Pulmonary Fibrosis; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: RC-P00120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No