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

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ClinicalTrials.gov Identifier: NCT02842463
Recruitment Status : Recruiting
First Posted : July 25, 2016
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
ADIR Association

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.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Pulmonary Rehabilitation 6-minute Stepper Test Other: 2 times : 6-minute stepper test with a rest of 20min between each test.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of the 6-minute Stepper Test to Individualise Pulmonary Rehabilitation in Patients With Mild to Moderate Chronicle Obstructive Pulmonary Disease
Study Start Date : July 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronicle obstructive pulmonary disease reffered for pulmonary rehabilitation.
Criteria

Inclusion Criteria:

  • Age > 18 ans ;
  • Chronicle obstructive pulmonary disease stage I/II (FEV1 ≥ 50%) ;
  • 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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842463


Contacts
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Contact: Tristan Bonnevie, MsC 02 65 59 29 70 ext +33 rehabilitation@adir-hautenormandie.com

Locations
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France
ADIR Association Recruiting
Bois-Guillaume, France
Contact: Tristan Bonnevie    02 35 59 27 70    rehabilitation@adir-hautenormandie.com   
Centre Hostalier Intercommunal Elbeuf-Louviers-Val de Reuil Recruiting
Elbeuf, France
Contact: Pierre-Alexandre Hauss, MD         
Groupe Hospitalier du Havre Recruiting
Le Havre, France
Contact: Clément Médrinal, MD         
Sponsors and Collaborators
ADIR Association
Investigators
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Principal Investigator: David Debeaumont, MD CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Study Chair: 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
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Responsible Party: ADIR Association
ClinicalTrials.gov Identifier: NCT02842463    
Other Study ID Numbers: 6STaR
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases