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

Chronic Obstructive Pulmonary Disease Clinical Trial

— 6STaR  

Official title:

Use of the 6-minute Stepper Test to Individualise Pulmonary Rehabilitation in Patients With Mild to Moderate Chronicle Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02842463
• Other study ID #: 6STaR
• Status: Completed
• Start date: July 2016
• Est. completion date: December 2023

Study information

• Verified date: March 2024
• Source: ADIR Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• 6-minute Stepper Test
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Rehabilitation

Intervention

Other:
• 2 times : 6-minute stepper test with a rest of 20min between each test.

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
ADIR Association

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Outcome (heart rate) during different tests will be continuously recorded. Relation will be adjusted for age and step count.	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.
Secondary	Relation between minimal SpO2 (%)from the 6-minute stepper test and SpO2 (%) from first ventilatory threshold from cardiopulmonary exercise testing.	Outcome (SpO2 (%)) during different tests will be continuously recorded. Relation will be adjusted for age en step count.	SpO2 will be assessed with oximeter. All theses tests wil be carried out in a total time frame of 3 month maximum.
Secondary	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.
Secondary	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.