Exercise Tolerance and Lower-limb Muscle Power in Patients With Chronic Respiratory Disease
- Conditions
- Pulmonary FibrosisPulmonary Disease, Chronic Obstructive
- Interventions
- Other: Functional capacity tests
- Registration Number
- NCT06124859
- Lead Sponsor
- Lille Catholic University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with a diagnosis of COPD (GOLD II- V) or pulmonary fibrosis (>6 months). Functional capacity tests -
- Primary Outcome Measures
Name Time Method Oxygen consumption 19 days 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.
Lower limb muscle power after Five Times Sit to Stand Test (5STS,) calculated by the ratio between STS mean velocity and STS mean force 19 days 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.
- Secondary Outcome Measures
Name Time Method Respiratory rate after 6MST 19 days 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)
Maximum effort test after 6MST 19 days 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.
Oxygen saturation after 6MST 19 days 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)
Lower limb muscle power after 5STS test 19 days 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.
Heart rate after 6MST 19 days 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)
Minute ventilation after 6MST 19 days 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)
Leg fatigue after 6MST measured by the modified Borg scale 19 days 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.
Trial Locations
- Locations (2)
Centre de Pneumologie Institut universitaire de cardiologie et de pneumologie de Québec
🇨🇦Québec, Canada
Hôpital Saint-Philibert (GHICL)
🇫🇷Lomme, France