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CompletedNCT028424636STaRUpdated Mar 21, 2024

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

An observational study in Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation and 6-minute Stepper Test, sponsored by ADIR Association. Completed at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-21.

Sponsored by ADIR Association · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
105
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease
  • Pulmonary Rehabilitation
  • 6-minute Stepper Test
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 105 is below the median of 157 across 929 observational studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

ADIR Association is the lead sponsor of 26 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with chronicle obstructive pulmonary disease reffered for pulmonary rehabilitation.

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

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.).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
105 participants (actual)
Patient registry
No

Groups and cohorts

  • Prospective observational cohort

    Every patient referred to pulmonary rehabilitation program will be eligible. They will perform cardiopulmonary exercise testing prior to join rehabilitation program. During the first session of pulmonary rehabilitation, they will perform 2 6-minute stepper test with a rest of 20 minutes minimum between each test.

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

Interventions

  • Other2 times : 6-minute stepper test with a rest of 20min between each test.
06

What researchers measure

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.

    Outcome (heart rate) during different tests will be continuously recorded. Relation will be adjusted for age and step count.

    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.

Secondary outcomes

  1. 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.

    Time frame: SpO2 will be assessed with oximeter. All theses tests wil be carried out in a total time frame of 3 month maximum.

  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.

07

Study locations

4 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02842463
Lead sponsor
ADIR Association
Responsible party
Sponsor
First posted
Jul 25, 2016
Start date
Jul 2016
Primary completion
Dec 2023
Completion
Dec 2023
Last update
Mar 21, 2024

Study contacts

David Debeaumont, MD
principal investigator · CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Catherine Tardif, MD
study chair · CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Antoine Cuvelier, Prof, PhD
study chair · CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France.
Tristan Bonnevie, MsC
study chair · ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
Francis-Edouard Gravier, PT
study chair · ADIR Association, Bois-Guillaume, France
Catherine Viacroze, MD
study chair · CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
Jean-François Muir, Prof, PhD
study chair · CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; ADIR Association, Bois-Guillaume, France
Bouchra Lamia, Prof, PhD
study chair · UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
Jean Quieffin, MD
study chair · Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
Guillaume Prieur, PT, MsC
study chair · Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
Clément Médrinal, PT, MsC
study chair · UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France. Service de réanimation, Groupe Hospitalier du Havre, France
Pierre-Alexandre Hauss, MD
study chair · Service de pneumologie, Centre Hosptalier Intercommunal Elbeuf-Louviers-Val de Reuil
View the source record on ClinicalTrials.gov ↗

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