6-minute Stepper Test and Pulmonary Rehabilitation in Patients With Chronicle Obstructive Pulmonary Disease

Completed

• Conditions: 6-minute Stepper Test; Chronic Obstructive Pulmonary Disease; Pulmonary Rehabilitation

• Registration Number: NCT02842463
• Lead Sponsor: ADIR Association

Brief Summary

The purpose of this study is to determine, if it exists, a relation between plateau heart rate from the last 3 minutes of the 6-minute stepper test and heart rate from first ventilatory threshold from cardiopulmonary exercise testing in order to individualise pulmonary rehabilitation in patients with mild to moderate chronicle obstructive pulmonary disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-25
• Primary Completion: 2023-12
• Study Completion: 2023-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Age > 18 ans ;
• Chronicle obstructive pulmonary disease stage I/II (FEV1 ≥ 50%) ;
• Chronicle obstructive pulmonary disease stage III/IV (FEV1 < 50%) from may 2019 (ethical approvement granted)
• Weight ≤ 90kg ;
• Eligible for pulmonary rehabilitation.

Exclusion Criteria

• Pregnant woman or likely to be ;
• Patient under guardianship ;
• Contraindication to cardiopulmonary exercise testing ;
• Patient medically treated with heart rate modulator (excluding oral B2-agonist) ;
• Patient treated with pacemaker or defibrillator ;
• History of lower limb impairment (i.e. peripheral artery disease, orthopedic disorder etc.).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relation between plateau heart rate (bpm) from the first and last 3 minutes of the 6-minute stepper test and heart rate (bpm) from first ventilatory threshold from cardiopulmonary exercise testing.	Heart rate (bpm) will be assessed during cardiopulmonary exercise testing with electrocardiogram. During the 2 6-minute stepper test, heart will be assessed with oximeter. All theses tests wil be carried out in a total time frame of 3 month maximum.	Outcome (heart rate) during different tests will be continuously recorded. Relation will be adjusted for age and step count.

Secondary Outcome Measures

Name	Time	Method
Relation between minimal SpO2 (%)from the 6-minute stepper test and SpO2 (%) from first ventilatory threshold from cardiopulmonary exercise testing.	SpO2 will be assessed with oximeter. All theses tests wil be carried out in a total time frame of 3 month maximum.	Outcome (SpO2 (%)) during different tests will be continuously recorded. Relation will be adjusted for age en step count.
Steps during 6-minute stepper test using stepper device.	The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day.
Blood pressure (mmHg) before and after every 6-minute stepper test using electrical blood pressure device.	The outcome will be assessed before and after every 6-minute stepper test. The 2 6-minute stepper test will be carried out the same day (minimum 20 minute of rest between each test) for a total time frame of 1 day.

Trial Locations

Locations (4)

ADIR Association; 🇫🇷 Bois-Guillaume, France

Centre Hostalier Intercommunal Elbeuf-Louviers-Val de Reuil; 🇫🇷 Elbeuf, France

Groupe Hospitalier du Havre; 🇫🇷 Le Havre, France

Centre Hospitalier de Morlaix; 🇫🇷 Morlaix, France