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

NCT04004689 | Unknown

• 1 other identifier: 6STaR-2
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 4

Brief Summary

Chronicle obstructive pulmonary disease is a worldwide cause of mortality and morbidity. This systemic disease progressively leads to dyspnea, muscle wasting and exercise capacity impairment. Pulmonary rehabilitation is a cornerstone in the management of these systemic effects. Unfortunately, access to pulmonary rehabilitation is limited for many people who would benefit from it, primarily because of a lack of pulmonary rehabilitation and assessment centers. Optimal assessment should include cardiopulmonary exercise testing to determine both the optimal training settings as well as any cardiopulmonary contraindications to pulmonary rehabilitation. However, this is not available in most centers and when it is, consultations are limited. Therefore, pulmonary rehabilitation is often delayed for several weeks and patients can lose motivation. In order to promote pulmonary rehabilitation, the incremental cardiopulmonary exercise testing could be replaced by field tests to individualize pulmonary rehabilitation prescription. The 6-minute stepper test is a new field tool. Its sensitivity and reproducibility have previously been reported in patients with chronicle obstructive pulmonary disease. It is easy to set up in the clinical setting and could be used to individualize pulmonary rehabilitation. The aim of this study was to develop and validate a prediction equation to set rehabilitation intensity for patients with severe to very severe chronicle obstructive pulmonary disease attending pulmonary rehabilitation, with the use of a simple, readily available field test. Therefore the investigators sought to determine, if it exists, a relationship between the plateau heart rate from the first and last 3 minutes of the 6-minute stepper test and the heart rate from the first ventilatory threshold from the cardiopulmonary exercise testing in order to individualize pulmonary rehabilitation in patients with severe to very severe 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 (6)

• 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.

• Diastolic 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.

• Systolic 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.

• Dyspnea using the Borg scale.

  Dyspnea will be assessed at the end of every tests for a total time frame of 2 hours.

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 the 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

Patients will perform two 6-minute stepper tests separated by a rest period of at least 20 minutes. The second test will begin when the heart rate and the transcutaneous oxygen saturation values will be returned to baseline values. Standardization of the instructions for the test will be based on the actual guidelines for the 6-minute walk test. The test will be performed in an isolated room in order to avoid noise or external stimuli which can affect performance. The stepper will be placed near a door and the patient was allowed to put a hand on it if out of balance or exhausted. The height of the step will be fixed to 20 cm. A step was defined as the rise and lowering of one foot. The patient was informed of the time each minute. No other encouragement was given. Heart rate and transcutaneous oxygen saturation will be continuously recorded by a pulse oximetry.

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 severe to very severe chronicle obstructive pulmonary disease reffered for pulmonary rehabilitation.

You may qualify if:

• Age \> 18 ans ;
• Chronicle obstructive pulmonary disease stage III/IV (FEV1 \< 50%) ;
• Weight ≤ 90kg ;
• Eligible for pulmonary rehabilitation ;
• A first ventilatory threshold has been identified during a previously performed incremental cardiopulmonary exercise testing.

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

RECRUITING

Centre Hostalier Intercommunal Elbeuf-Louviers-Val de Reuil

Elbeuf, France

RECRUITING

Groupe Hospitalier du Havre

Le Havre, France

RECRUITING

Centre Hospitalier de Morlaix

Morlaix, France

RECRUITING

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

Central Study Contacts

Tristan Bonnevie, MsC

CONTACT

02 65 59 29 70; rehabilitation@adir-hautenormandie.com

Study Design

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

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 2, 2019
• Study Start: August 1, 2019
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)