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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2022
  • participants needed
    80
  • sponsor
    ADIR Association
Updated on 1 February 2021
dyspnea
pulmonary rehabilitation

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.

Description

Experimental design:

The validation of the six-minute stepper test to prescribe endurance training in severe to very severe chronicle obstructive pulmonary disease involves two steps :

  1. Patients with severe to very severe chronicle obstructive pulmonary disease who performed an incremental cardiopulmonary exercise testing and are referred to pulmonary rehabilitation will be approached to participate in the study.

Eligible patients who agree to participate in the study and sign informed consent will perform two six-minute stepper test. Their performance and heart rate (first and last 3minutes) will be compared with those obtained at the first ventilatory threshold from the previously performed incremental cardiopulmonary exercise testing (usually used for the prescription of endurance training in pulmonary rehabilitation) using multiple regression in order to derive a predictive equation.

2. The validity of this predictive equation will be assessed in an independent cross-validation group issued from a completed multicenter observational study (NCT03244137). This cross-validation group will be formed with those patients of this cohort who performed both the incremental cardiopulmonary exercise testing (and had a determined first ventilatory threshold) and the six-minute stepper test. The heart rate prescription for endurance training from the direct measurement of the the first ventilatory threshold will be compared to the heart rate derived from the 6minute-stepper test using the predictive equation determined in step 1. Data will be compared using the mean absolute difference between both prescriptions and a Bland-Altman analysis.

Details
Condition Chronic Obstructive Lung Disease, COPD (Chronic Obstructive Pulmonary Disease), Pulmonary Rehabilitation, 6-minute Stepper Test, chronic obstructive pulmonary disease, rehabilitation pulmonary, COPD, chronic obstructive pulmonary disease (copd), 6-minute Stepper Test, 6-minute Stepper Test
Treatment 2 times : 6-minute stepper test with a rest of 20min between each test.
Clinical Study IdentifierNCT04004689
SponsorADIR Association
Last Modified on1 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: 6-minute Stepper Test or Chronic Obstructive Lung Disease or Pulmonary Rehabilitation?
Do you have any of these conditions: Pulmonary Rehabilitation or chronic obstructive pulmonary disease (copd) or rehabilitation pulmonary or chronic obstructive pulmonary disease or COPD ...?
Do you have any of these conditions: chronic obstructive pulmonary disease (copd) or chronic obstructive pulmonary disease or rehabilitation pulmonary or 6-minute Stepper Test or Chronic ...?
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

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.)
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note