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ClinicalTrials.gov ID

NCT06124859

Lead Sponsor

Lille Catholic UniversityOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

30Estimated

Last Update Posted

Nov 9, 2023Actual

Start Date

Nov 2023Estimated

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2024Estimated

Official Title

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

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.

• Pulmonary Fibrosis
• Pulmonary Disease, Chronic Obstructive

• Functional capacity tests

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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

Primary Purpose

Diagnostic

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Lille Catholic UniversityOTHER

Collaborators

University of Lille Nord de FranceOTHER

Chambellan.Arnaud@ghicl.net