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

NCT06124859 | Unknown

• 1 other identifier: RC-P00120
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

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.

Conditions

Pulmonary Fibrosis; Pulmonary Disease, Chronic Obstructive

Keywords

Six minutes stepper test (6MST); 5-times sit to stand test (5STS); Chronic obstructive pulmonary disease (COPD); Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Heart rate after 6MST

  19 days

• Oxygen saturation after 6MST

  19 days

• Minute ventilation after 6MST

  19 days

• Respiratory rate after 6MST

  19 days

• Leg fatigue after 6MST measured by the modified Borg scale

  19 days

Study Arms (1)

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

EXPERIMENTAL

Other: Functional capacity tests

Interventions

Functional capacity tests OTHER

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)

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lille Catholic University: lead
• University of Lille Nord de France: collaborator

Study Sites (2)

Centre de Pneumologie Institut universitaire de cardiologie et de pneumologie de Québec

Québec, G1V 4G5, Canada

Location

Hôpital Saint-Philibert (GHICL)

Lomme, 59160, France

Location

MeSH Terms

Conditions

Pulmonary Fibrosis; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes

Study Officials

• Arnaud CHAMBELLAN, MD

  Hôpital Saint Philibert, GHICL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Paule LEBITASY, MD

CONTACT

+33320225269; Lebitasy.Marie-Paule@ghicl.net

William's VAN DEN BERGHE

CONTACT

+33320225731; VanDenBerghe.Williams@ghicl.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 9, 2023
• Study Start: November 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); CA (1)