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

NCT ID: NCT02842463

Last Updated: 2024-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Chronic Obstructive Pulmonary Disease Pulmonary Rehabilitation 6-minute Stepper Test

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

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

Intervention Type OTHER

Interventions

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

Intervention Type OTHER

Eligibility Criteria

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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.).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ADIR Association

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Debeaumont, MD

Role: PRINCIPAL_INVESTIGATOR

CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France

Catherine Tardif, MD

Role: 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

Role: 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

Role: 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

Role: STUDY_CHAIR

ADIR Association, Bois-Guillaume, France

Catherine Viacroze, MD

Role: STUDY_CHAIR

CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France

Jean-François Muir, Prof, PhD

Role: 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

Role: 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

Role: STUDY_CHAIR

Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers

Guillaume Prieur, PT, MsC

Role: STUDY_CHAIR

Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers

Clément Médrinal, PT, MsC

Role: 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

Role: STUDY_CHAIR

Service de pneumologie, Centre Hosptalier Intercommunal Elbeuf-Louviers-Val de Reuil

Locations

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ADIR Association

Bois-Guillaume, , France

Site Status

Centre Hostalier Intercommunal Elbeuf-Louviers-Val de Reuil

Elbeuf, , France

Site Status

Groupe Hospitalier du Havre

Le Havre, , France

Site Status

Centre Hospitalier de Morlaix

Morlaix, , France

Site Status

Countries

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France

References

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Bonnevie T, Clet A, Beaumont M, Smondack P, Combret Y, Medrinal C, Prieur G, Boujibar F, Muir JF, Cuvelier A, Grosbois JM, Debeaumont D, Artaud-Macari E, Gravier FE. Estimating endurance training intensity prescription from the 6-minute stepper test in people with chronic obstructive pulmonary disease - a multicenter cross-sectional study with external validation. Pulmonology. 2025 Dec 31;31(1):2486875. doi: 10.1080/25310429.2025.2486875. Epub 2025 Apr 11.

Reference Type DERIVED
PMID: 40211884 (View on PubMed)

Other Identifiers

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6STaR

Identifier Type: -

Identifier Source: org_study_id

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