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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02842463
Acronym
6STaR
Enrollment
105
Registered
2016-07-25
Start date
2016-07-31
Completion date
2023-12-31
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

6-minute Stepper Test, Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation

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.

Interventions

Sponsors

ADIR Association
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.).

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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.
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.
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026