Actively Recruiting
Multidimensional Approach for COPD and High Complexity
Led by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo · Updated on 2023-02-22
300
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The MACH Study trial will examine the impact on high complexity COPD patients of a multidimensional approach (moderate-intensity physical activity program and clinic-therapeutic re-evaluation of the participants)
CONDITIONS
Official Title
Multidimensional Approach for COPD and High Complexity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
- Diagnosed with COPD according to GOLD 2020 Guidelines or Heart Failure according to ESC 2016 Guidelines
- Diagnosed with at least two other chronic diseases in addition to COPD or Heart Failure
- Healthy subjects eligible only for the control group
- Chronic diseases considered include Type 1 or Type 2 Diabetes mellitus, Essential hypertension, Chronic Kidney Disease Stage 3b or worse, Chronic Anemia of moderate level or lower, Chronic liver disease of any cause, and Obesity (BMI ≥ 30)
You will not qualify if you...
- Active cigarette smoking
- Need for continuous supportive oxygen therapy
- Walking less than 300 meters in 6-minute walking test
- Unstable angina, history of cardiac arrest, severe heart failure (NYHA Class III or IV), severe left ventricular dysfunction (EF <30%), acute myocarditis, pericarditis, hypertrophic myocardiopathy, significant aortic stenosis, presence of cardiac defibrillator or heart transplant, history of large aortic aneurysm or repair
- Uncontrolled or partially controlled asthma, sleep apnea syndrome, history of pulmonary fibrosis
- Recent acute cardiac or cerebral event within last six months
- Child-Pugh B/C cirrhosis
- Body Mass Index ≥ 35
- Evidence of arrhythmias contraindicating physical activity
- Resting heart rate below 45 or above 100 beats per minute
- History of uncontrolled or partially controlled high blood pressure despite treatment
- Regular physical activity practice (only sedentary participants eligible)
- Inability to perform 24-week physical activity program due to medical reasons
- Acute or chronic diseases affecting systemic inflammation markers
- Muscle conditions affecting myokine release
- Acute bleeding or recent urgent anemia transfusion
- Active or recent cancer treatment
- Uncontrolled psychiatric disorders
- Recent alcohol or substance abuse
- Severe cognitive impairment or inability to comply
- Other conditions deemed exclusionary by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Domenico Di Raimondo
Palermo, Italy, 90127
Actively Recruiting
Research Team
D
Domenico Di Raimondo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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