Multidimensional Approach for COPD and High Complexity

Sponsor
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Study ID
NCT04986332
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Physical activity program — BEHAVIORAL
    24-weeks moderate-intensity physical activity program
  • Global therapeutic remodeling — OTHER
    Re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions

Study Details

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)

Key Dates

First listed
Aug 2, 2021
Start date
Sep 1, 2021
Status verified
Feb 2023
Primary completion
Sep 1, 2023
Completion
Sep 1, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GROUP "COPD"
    100 participants, 50 males and 50 females with COPD and multiple chronic conditions
  • Active Comparator: GROUP "HF"
    100 participants, 50 males and 50 females with HF and multiple chronic conditions
  • Active Comparator: GROUP "HEALTHY PARTICIPANTS"
    100 healthy participants or "control group" which will be compared to Group A and Group B by age and sex

Primary Outcome Measure

Cumulative incidence of COPD exacerbation of Group "COPD" [ Time Frame: Baseline to 12 months ]

Central Contacts

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