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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06124859
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Lille Catholic University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Arnaud CHAMBELLAN, MD
Principal Investigator Affiliation	Hôpital Saint Philibert, GHICL
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Canada, France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Fibrosis, Pulmonary Disease, Chronic Obstructive

Arms & Interventions

Arms

Experimental: Patients with a diagnosis of COPD (GOLD II- V) or pulmonary fibrosis (>6 months).

Interventions

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)

Contact a Trial Team

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