Status:
UNKNOWN
A Six Minute Walking Test Based Index as an Outcome Predictor in COPD Subjects. (Chronic Obstructive Pulmonary Disease)
Lead Sponsor:
Maugeri Foundation
Collaborating Sponsors:
Università degli Studi di Sassari
Conditions:
COPD
Mortality
Eligibility:
All Genders
45-85 years
Brief 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 Internatio...
Detailed 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 sever...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03799263
Start Date
February 1 2019
End Date
December 1 2023
Last Update
March 3 2023
Active Locations (1)
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1
Maugeri Foundation
Tradate, VA, Italy, 21049