Pulmonary FibrosisVTEPNCT06124859
Exercise Tolerance and Lower-limb Muscle Power in Patients With Chronic Respiratory Disease
A study testing Functional capacity tests in people with Pulmonary Fibrosis and Pulmonary Disease, Chronic Obstructive, run by Lille Catholic University at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Fibrosis, Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Functional capacity tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Canada1 site
Centre de Pneumologie Institut universitaire de cardiologie et de pneumologie de Québec
Québec, G1V 4G5
François MALTAIS, Francois.Maltais@fmed.ulaval.ca
France1 site
Hôpital Saint-Philibert (GHICL)
Lomme, 59160
Arnaud CHAMBELLAN, Chambellan.Arnaud@ghicl.net
About this study
Official title: 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.
- Being tested
- Functional capacity tests
- Keywords
- Six minutes stepper test (6MST), 5-times sit to stand test (5STS), Chronic obstructive pulmonary disease (COPD), Pulmonary Fibrosis
- Medical subject headings
- Pulmonary Fibrosis, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional capacity testsOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Patients with a diagnosis of COPD (GOLD II- V) or pulmonary fibrosis (>6 months). | Experimental | Not described Receives: Other: Functional capacity tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 19 days
Secondary outcomes (7)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study startNov 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lille Nord de France
- Responsible party
- Sponsor
- Investigators
- Arnaud CHAMBELLAN, MD, Principal investigator, Hôpital Saint Philibert, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124859
- Sponsor's protocol ID
- RC-P00120
- Acronym
- VTEP
- Status last verified
- Nov 2023
- First submitted
- 30 Oct 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Exercise Tolerance and Lower-limb Muscle Power in Patients With Chronic Respiratory Disease: a Multicenter Validity Study
- ClinicalTrials.gov ID
- NCT06124859
- Acronym / sponsor ID
- VTEP / RC-P00120
- Keywords
- Six minutes stepper test (6MST), 5-times sit to stand test (5STS), Chronic obstructive pulmonary disease (COPD), Pulmonary Fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- University of Lille Nord de France
- Study start
- Nov 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a diagnosis of COPD (GOLD II- V) or pulmonary fibrosis (>6 months). | Experimental | Other: Functional capacity tests |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional capacity testsMaximal 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) | Other | Patients with a diagnosis of COPD (GOLD II- V) or pulmonary fibrosis (>6 months). |
Primary outcome
Oxygen consumption
Time frame: 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
Time frame: 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.
7 secondary outcomes
Heart rate after 6MST
Time frame: 19 days
Oxygen saturation after 6MST
Time frame: 19 days
Minute ventilation after 6MST
Time frame: 19 days
Respiratory rate after 6MST
Time frame: 19 days
Leg fatigue after 6MST measured by the modified Borg scale
Time frame: 19 days
Maximum effort test after 6MST
Time frame: 19 days
Lower limb muscle power after 5STS test
Time frame: 19 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud CHAMBELLAN, MD principal investigator
Hôpital Saint Philibert, GHICL
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional capacity tests in people with Pulmonary Fibrosis and Pulmonary Disease, Chronic Obstructive, run by Lille Catholic University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Paule LEBITASY, MD (+33320225269, Lebitasy.Marie-Paule@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen consumption (time frame: 19 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.