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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— VTEP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06124859
• Other study ID #: RC-P00120
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Lille Catholic University
• Contact: Marie Paule LEBITASY, MD
• Phone: +33320225269
• Email: Lebitasy.Marie-Paule[@]ghicl.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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)

Locations

Country	Name	City	State
Canada	Centre de Pneumologie Institut universitaire de cardiologie et de pneumologie de Québec	Québec
France	Hôpital Saint-Philibert (GHICL)	Lomme

Sponsors (2)

Lead Sponsor	Collaborator
Lille Catholic University	University of Lille Nord de France

Countries where clinical trial is conducted

Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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