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

NCT02842463 | Completed

• 1 other identifier: 6STaR
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

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.

  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 (3)

• 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.

• 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.

Study Arms (1)

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

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

Prospective observational cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with chronicle obstructive pulmonary disease reffered for pulmonary rehabilitation.

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• ADIR Association: lead

Study Sites (4)

ADIR Association

Bois-Guillaume, France

Location

Centre Hostalier Intercommunal Elbeuf-Louviers-Val de Reuil

Elbeuf, France

Location

Groupe Hospitalier du Havre

Le Havre, France

Location

Centre Hospitalier de Morlaix

Morlaix, France

Location

Related Publications (1)

• 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.

  PMID: 40211884 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Debeaumont, MD

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

  PRINCIPAL INVESTIGATOR

• Catherine Tardif, MD

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

  STUDY CHAIR

• Antoine Cuvelier, Prof, PhD

  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.

  STUDY CHAIR

• Tristan Bonnevie, MsC

  ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France

  STUDY CHAIR

• Francis-Edouard Gravier, PT

  ADIR Association, Bois-Guillaume, France

  STUDY CHAIR

• Catherine Viacroze, MD

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

  STUDY CHAIR

• Jean-François Muir, Prof, PhD

  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

  STUDY CHAIR

• Bouchra Lamia, Prof, PhD

  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

  STUDY CHAIR

• Jean Quieffin, MD

  Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers

  STUDY CHAIR

• Guillaume Prieur, PT, MsC

  Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers

  STUDY CHAIR

• Clément Médrinal, PT, MsC

  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

  STUDY CHAIR

• Pierre-Alexandre Hauss, MD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 25, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

FR (4)