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Completed

NCT Number: NCT02842463

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease 6-minute Stepper Test Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Pulmonary Rehabilitation Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ADIR Association, Bois-Guillaume, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

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

Other

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. Relation between minimal SpO2 (%)from the 6-minute stepper test and SpO2 (%) from first ventilatory threshold from cardiopulmonary exercise testing.

    Time frame: 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.

  2. Blood pressure (mmHg) before and after every 6-minute stepper test using electrical blood pressure device.

    Time frame: 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.

  3. Steps during 6-minute stepper test using stepper device.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

ADIR Association

Other

Registry information

Official study title

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

Acronym: 6STaR

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Jul 25, 2016
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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