A Six Minute Walking Test Based Index as an Outcome Predictor in COPD Subjects. (Chronic Obstructive Pulmonary Disease)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    100
  • sponsor
    Maugeri Foundation
Updated on 10 February 2021

Summary

The six minute walking test (6MWT) is a recognized clinical test to evaluate exercise capacity in different diseases and different conditions. The modalities of performance are described in International Guidelines. The usually reported measure is the distance in meters walked in 6 minutes. Despite the report of a single variable during the test is considered as a limit, changes in monitored variables are seldom analyzed together with the distance walked. In the past there have been some attempts of multifactorial evaluation of 6MWT, however up to date, there is no system considering together the changes of different variables. The investigators wonder whether a multidimensional index based on variables monitored during the 6MWT would better predict 24 month exacerbations and mortality in COPD patients.

Description

Rationale: the six minute walking test (6MWT) is a recognized clinical test to evaluate exercise capacity in different diseases and different conditions. In COPD patients the 6MWT is a marker of severity, influenced by the severity of airway obstruction as well as of comorbidities. This test has been shown as a predictor of survival and need of hospitalization. The modalities of performance are described in International Guidelines. The usually reported measure is the distance in meters walked in 6 minutes. However, besides the pathological conditions, this result is influenced by the individual demographic and anthropometrics characteristics. The Minimal Clinically Important Difference in COPD subjects is reported to be 30 meters (m.). A decrease greater than 30 m., as compared to the previous year, is a predictor of death risk. During the test some physiological variables should be monitored such as heart rate (HR), and pulse oxymetry (SpO2). An oxyhemoglobin desaturation >4% or a SpO2 <90% during the test, are also predictors of increased risk of death or hospitalization. In addition, also the difference between the HR at baseline and that after one minute after the end of the test (recovery heart rate: HRR) seems to be a predictor of survival and COPD exacerbation rates. Despite the report of a single variable during the test is considered as a limit, changes in monitored variables are seldom analyzed together with the distance walked. In the past there have been some attempts of multifactorial evaluation of 6MWT, however up to date, there is no system considering together the changes of different variables. We wonder whether a multidimensional index based on variables monitored during the 6MWT would better predict 24 month exacerbations and mortality in COPD patients.

Objectives

Primary Objective: To develop and validate a multidimensional index in COPD subjects with different grades of severity as assessed by the Global Initiative for Chronic Obstructive Lung disease as a predictor of 24 month exacerbation rate.

Secondary Objectives: To evaluate the predictive value of 24 month mortality. To evaluate the relationship of this index and other accepted clinical predictors.

Details
Condition Aspects of mortality statistics, Chronic Obstructive Lung Disease, COPD (Chronic Obstructive Pulmonary Disease), Chronic Obstructive Lung Disease, Disease Progression, Mortality, COPD (Chronic Obstructive Pulmonary Disease), Exercise Capacity, Reactive Airway Disease, chronic obstructive pulmonary disease, COPD, chronic obstructive pulmonary disease (copd)
Treatment Evaluation Group
Clinical Study IdentifierNCT03799263
SponsorMaugeri Foundation
Last Modified on10 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

COPD diagnosis and grades of severity as assessed by the "old" (I to IV) and "new" (A to D) GOLD guidelines (23)
Under inhaler therapy for 30 days according to guidelines (23)
Smokers or o ex-smokers, smoke history 10 pack/years (p/y)
Informed Consent Signature

Exclusion Criteria

Associated Comorbidities with short term severe prognosis
Actual Cardiac Arrythmias
Pace-maker
Other associated respiratory diseases
Chronic Heart Failure New York Heart Association classes III, IV
Use of drugs influencing the heart rate
Changes in drug therapy in the previous 30 days
Use of systemic steroids or antibiotics in the previous 30 days
Unscheduled visits or admission to the Emergency Room for symptoms worsening in the previous 30 days
Pneumonia during the previous 60 days
Myocardial Infarction in the previous 4 months
Subjective and objective inability to perform the 6MWT
Inability to carry the oxygen cylinder
Clear my responses

How to participate?

Step 1 Connect with a study center
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

Primary Contact

site

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...

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