Recruiting
NA
INTERVENTIONAL
NCT04986332
Multidimensional Approach for COPD and High Complexity
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
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)
Detailed Description
MACH Study investigators designed a trial to evaluate in high complexity subjects (at least 2 chronic diseases): * in the COPD cohort, the impact of a multidimensional approach involving global therapeutic remodeling (re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions) plus a 24-weeks moderate intensity physical activity program on: number of total and severe exacerbations; number of total and COPD/related hospitalizations; quality of life; survival over a 36 months follow-up period; * to establish whether a higher index of comorbidity and polypharmacy is independently associated with a worst clinical severity of COPD, an increased risk of exacerbations and a reduced survival; * the role played by specific clinical-laboratory markers of comorbidity (blood iron profile, hemochromocytometric parameters, renal function, blood pressure profile, glycemic compensation, Body Mass Index, lipid profile) and specific multidimensional tests in identifying COPD patients with higher clinical risk of rapid disease decline and/or higher risk of exacerbations and COPD-related hospitalizations; * to establish the role of Heart Failure as the most impactful comorbidity of COPD: assess the incidence rate and the relative risk of total/severe exacerbation and the incidence rate and the relative risk of total/COPD-related hospitalizations in Heart Failure/COPD patients over a 36-months follow-up period; * at the enrollment time (zero time) and after 12, 24 and 36 months, circulating levels of several systemic inflammation biomarkers. Correlate their variation over time with the comorbidity indexes, global pharmacological therapeutic redefinition and lifestyle intervention centered on 24-weeks physical activity program; * at the enrollment time (zero time) and after 12, 24 and 36 months, plasma levels of the main miRNAs involved in the COPD pathogenesis. Correlate their variation over time with the comorbidity indexes, global pharmacological therapeutic redefinition and lifestyle intervention centered on 24-weeks physical activity program; * at the enrollment time (zero time) and after 12, 24 and 36 months, plasma levels of the main myokines currently associated with the systemic effects of physical activity, correlating their baseline concentration to clinical-anthropometric parameters and type and number of chronic diseases and their variation over time in relation to the global pharmacological therapeutic redefinition and the 24-weeks physical activity program;
Interventions
Name:
Physical activity program
Type:
BEHAVIORAL
Description:
24-weeks moderate-intensity physical activity program
Name:
Global therapeutic remodeling
Type:
OTHER
Description:
Re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions
Primary Outcomes
Measure:
Cumulative incidence of COPD exacerbation of Group "COPD"
TimeFrame:
Baseline to 12 months
Description:
The effect of a 24-weeks moderate-intensity physical activity program and re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions on the number of COPD exacerbation per year.
The severity of COPD exacerbation will be assessed as follow:
Mild: treated with short acting bronchodilators only; Moderate: treated with bronchodilators and/or oral corticosteroids; Severe: patient requires hospitalization or visits the emergency room;
Measure:
Cumulative incidence of COPD exacerbation of Group "COPD"
TimeFrame:
Baseline to 24 months
Description:
The effect of a 24-weeks moderate-intensity physical activity program and re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions on the number of COPD exacerbation per year.
The severity of COPD exacerbation will be assessed as follow:
Mild: treated with short acting bronchodilators only; Moderate: treated with bronchodilators and/or oral corticosteroids; Severe: patient requires hospitalization or visits the emergency room;
Measure:
Cumulative incidence of COPD exacerbation of Group "COPD"
TimeFrame:
Baseline to 36 months
Description:
The effect of a 24-weeks moderate-intensity physical activity program and re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions on the number of COPD exacerbation per year.
The severity of COPD exacerbation will be assessed as follow:
Mild: treated with short acting bronchodilators only; Moderate: treated with bronchodilators and/or oral corticosteroids; Severe: patient requires hospitalization or visits the emergency room;
Measure:
Cumulative incidence of hospitalization for pneumonia of Group "COPD"
TimeFrame:
Baseline to 12 months
Description:
The effect of a 24-weeks moderate-intensity physical activity program and re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions on the number of hospitalization per year for pneumonia.
Pneumonia will be ascertain clinically and/or radiologically.
Measure:
Cumulative incidence of hospitalization for pneumonia of Group "COPD"
TimeFrame:
Baseline to 24 months
Description:
The effect of a 24-weeks moderate-intensity physical activity program and re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions on the number of hospitalization per year for pneumonia.
Pneumonia will be ascertain clinically and/or radiologically.
Measure:
Cumulative incidence of hospitalization for pneumonia of Group "COPD"
TimeFrame:
Baseline to 36 months
Description:
The effect of a 24-weeks moderate-intensity physical activity program and re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions on the number of hospitalization per year for severe COPD exacerbation and pneumonia.
Pneumonia will be ascertain clinically and/or radiologically.
Measure:
Cumulative incidence of hospitalizations for any cause of Group A
TimeFrame:
Baseline to 12 months
Description:
The effect of a 24-weeks moderate-intensity physical activity program and re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions on the number of hospitalization for any cause per year.
Measure:
Cumulative incidence of hospitalizations for any cause of Group A
TimeFrame:
Baseline to 24 months
Description:
The effect of a 24-weeks moderate-intensity physical activity program and re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions on the number of hospitalization for any cause per year.
Measure:
Cumulative incidence of hospitalizations for any cause of Group A
TimeFrame:
Baseline to 36 months
Description:
The effect of a 24-weeks moderate-intensity physical activity program and re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions on the number of hospitalization for any cause per year.
Measure:
Mortality rate of Group "COPD"
TimeFrame:
Baseline to 12 months
Description:
The number of total deaths in the time frame of 12 months in Group "COPD"
Measure:
Mortality rate of Group "COPD"
TimeFrame:
Baseline to 24 months
Description:
The number of total deaths in the time frame of 24 months in Group "COPD"
Measure:
Mortality rate of Group "COPD"
TimeFrame:
Baseline to 36 months
Description:
The number of total deaths in the time frame of 36 months in Group "COPD"
Measure:
Change over time from baseline in Mini Nutritional Assessment-Short Form total score of Group "COPD"
TimeFrame:
Baseline to post-interventions at 12 months
Description:
Mini Nutritional Assessment is a simple tool that helps physicians to have knowledge of nutritional status in elderly persons. It was well validated in the hospital, community and long-term care settings.
Measure:
Change over time from baseline in Mini Nutritional Assessment-Short Form total score of Group "COPD"
TimeFrame:
Baseline to 24 months
Description:
Mini Nutritional Assessment is a simple tool that helps physicians to have knowledge of nutritional status in elderly persons. It was well validated in the hospital, community and long-term care settings.
Measure:
Change over time from baseline in Mini Nutritional Assessment-Short Form total score of Group "COPD"
TimeFrame:
Baseline to 36 months
Description:
Mini Nutritional Assessment is a simple tool that helps physicians to have knowledge of nutritional status in elderly persons. It was well validated in the hospital, community and long-term care settings.
Measure:
Change over time from baseline in EQ-5D-3L of Group "COPD"
TimeFrame:
Baseline to post-interventions at 12 months
Description:
The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life instrument using a three-level scale 1-3 (no problem, some problems and extreme problems)
Measure:
Change over time from baseline in EQ-5D-3L of Group "COPD"
TimeFrame:
Baseline to 24 months
Description:
The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life instrument using a three-level scale 1-3 (no problem, some problems and extreme problems)
Measure:
Change over time from baseline in EQ-5D-3L of Group "COPD"
TimeFrame:
Baseline to 36 months
Description:
The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life instrument using a three-level scale 1-3 (no problem, some problems and extreme problems)
Measure:
Change over time from baseline in mMRC of Group "COPD"
TimeFrame:
Baseline to post-interventions at 12 months
Description:
mMRC is a simple tool that investigates the measure of breathlessness of COPD subjects.
Grade 0: "I only get breathless with strenuous exercise " Grade 1: I get short of breath when hurrying on the level or walking up a slight hill" Grade 2: "I walk slower than people of same age on the level because of breathlessness or I have to stop to catch breath when walking at their own pace on the level" Grade 3: "I stop for breath after walking ∼100 m or after few minutes on the level" Grade 4: "I am too breathless to leave the house, or breathless when dressing or undressing"
Measure:
Change over time from baseline in mMRC of Group "COPD"
TimeFrame:
Baseline to 24 months
Description:
mMRC is a simple tool that investigates the measure of breathlessness of COPD subjects.
Grade 0: "I only get breathless with strenuous exercise " Grade 1: I get short of breath when hurrying on the level or walking up a slight hill" Grade 2: "I walk slower than people of same age on the level because of breathlessness or I have to stop to catch breath when walking at their own pace on the level" Grade 3: "I stop for breath after walking ∼100 m or after few minutes on the level" Grade 4: "I am too breathless to leave the house, or breathless when dressing or undressing"
Measure:
Change over time from baseline in mMRC of Group "COPD"
TimeFrame:
Baseline to 36 months
Description:
mMRC is a simple tool that investigates the measure of breathlessness of COPD subjects.
Grade 0: "I only get breathless with strenuous exercise " Grade 1: I get short of breath when hurrying on the level or walking up a slight hill" Grade 2: "I walk slower than people of same age on the level because of breathlessness or I have to stop to catch breath when walking at their own pace on the level" Grade 3: "I stop for breath after walking ∼100 m or after few minutes on the level" Grade 4: "I am too breathless to leave the house, or breathless when dressing or undressing"
Measure:
Change over time from baseline in CAT of Group "COPD"
TimeFrame:
Baseline to post-interventions at 12 months
Description:
The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. The CAT is simple to administer, and aims to help clinicians, with their patients, better manage COPD.
Measure:
Change over time from baseline in CAT of Group "COPD"
TimeFrame:
Baseline to 24 months
Description:
The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. The CAT is simple to administer, and aims to help clinicians, with their patients, better manage COPD.
Measure:
Change over time from baseline in CAT of Group "COPD"
TimeFrame:
Baseline to 36 months
Description:
The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. The CAT is simple to administer, and aims to help clinicians, with their patients, better manage COPD.
Measure:
Change over time from baseline in Barthel Index of Group "COPD"
TimeFrame:
Baseline to post interventions at 12 months
Description:
The Maryland Disability Index (formally Barthel Index) was codified in the late 1950s by the english nurse Barthel. It allows to have knowledge of the degree of subject's independence. It consists of 10 items that explore common "Activities of Daily Living (ADL)", from nutrition to the ability to climb or descend stairs. Each item is assigned an arbitrary score of 5, 10 or 15 points (maximum 100). The sum indicates the degree of autonomy of the patient in carrying out daily activities.
Measure:
Change over time from baseline in Barthel Index of Group "COPD"
TimeFrame:
Baseline to 24 months
Description:
The Maryland Disability Index (formally Barthel Index) was codified in the late 1950s by the english nurse Barthel. It allows to have knowledge of the degree of subject's independence. It consists of 10 items that explore common "Activities of Daily Living (ADL)", from nutrition to the ability to climb or descend stairs. Each item is assigned an arbitrary score of 5, 10 or 15 points (maximum 100). The sum indicates the degree of autonomy of the patient in carrying out daily activities.
Measure:
Change over time from baseline in Barthel Index of Group "COPD"
TimeFrame:
Baseline to 36 months
Description:
The Maryland Disability Index (formally Barthel Index) was codified in the late 1950s by the english nurse Barthel. It allows to have knowledge of the degree of subject's independence. It consists of 10 items that explore common "Activities of Daily Living (ADL)", from nutrition to the ability to climb or descend stairs. Each item is assigned an arbitrary score of 5, 10 or 15 points (maximum 100). The sum indicates the degree of autonomy of the patient in carrying out daily activities.
Measure:
Change over time from baseline in 6-minutes Walking Test (6-mWT) of Group "COPD"
TimeFrame:
Baseline to post interventions at 12 months
Description:
The 6-mWT measures the distance a subject walks while walking fast. The protocol used is standardized (a protocol with written instructions identical for all is used) and performed by specially trained personnel
Measure:
Change over time from baseline in 6-minutes Walking Test (6-mWT) of Group "COPD"
TimeFrame:
Baseline to 24 months
Description:
The 6-mWT measures the distance a subject walks while walking fast. The protocol used is standardized (a protocol with written instructions identical for all is used) and performed by specially trained personnel
Measure:
Change over time from baseline in 6-minutes Walking Test (6-mWT) of Group "COPD"
TimeFrame:
Baseline to 36 months
Description:
The 6-mWT measures the distance a subject walks while walking fast. The protocol used is standardized (a protocol with written instructions identical for all is used) and performed by specially trained personnel
Measure:
Change over time from baseline in BODE Index of Group "COPD"
TimeFrame:
Baseline to post-interventions at 12 months
Description:
The BODE index, for Body-mass index, airflow Obstruction, Dyspnea, and Exercise, is a multidimensional scoring system and capacity index originally designed to predict mortality in patients with COPD.
Measure:
Change over time from baseline in BODE Index of Group "COPD"
TimeFrame:
Baseline to 24 months
Description:
The BODE index, for Body-mass index, airflow Obstruction, Dyspnea, and Exercise, is a multidimensional scoring system and capacity index originally designed to predict mortality in patients with COPD.
Measure:
Change over time from baseline in BODE Index of Group "COPD"
TimeFrame:
Baseline to 36 months
Description:
The BODE index, for Body-mass index, airflow Obstruction, Dyspnea, and Exercise, is a multidimensional scoring system and capacity index originally designed to predict mortality in patients with COPD.
Measure:
Change over time from baseline in 24-hour average systolic and diastolic pressures of Group "COPD"
TimeFrame:
Baseline to post-interventions at 12 months
Description:
24-hour average systolic and diastolic pressures will be assessed performing a 24-hour Ambulatory Blood Pressure Monitoring.
Measure:
Change over time from baseline in 24-hour average systolic and diastolic pressures of Group "COPD"
TimeFrame:
Baseline to 24 months
Description:
24-hour average systolic and diastolic pressures will be assessed performing a 24-hour Ambulatory Blood Pressure Monitoring.
Measure:
Change over time from baseline in 24-hour average systolic and diastolic pressures of Group "COPD"
TimeFrame:
Baseline to 36 months
Description:
24-hour average systolic and diastolic pressures will be assessed performing a 24-hour Ambulatory Blood Pressure Monitoring.
Measure:
Change over time from baseline in heart rate variability of Group "COPD"
TimeFrame:
Baseline to post-interventions at 12 months
Description:
Heart rate variability will be assessed performing a 24-ECG Holter
Measure:
Change over time from baseline in heart rate variability of Group "COPD"
TimeFrame:
Baseline to 24 months
Description:
Heart rate variability will be assessed performing a 24-ECG Holter
Measure:
Change over time from baseline in heart rate variability of Group "COPD"
TimeFrame:
Baseline to 36 months
Description:
Heart rate variability will be assessed performing a 24-ECG Holter
Measure:
Change over time from baseline in fasting blood sugar of Group "COPD"
TimeFrame:
Baseline to post-interventions at 12 months
Description:
Fasting blood sugar will be performed using the the dextrostix
Measure:
Change over time from baseline in fasting blood sugar of Group "COPD"
TimeFrame:
Baseline to 24 months
Description:
Fasting blood sugar will be performed using the the dextrostix
Measure:
Change over time from baseline in fasting blood sugar of Group "COPD"
TimeFrame:
Baseline to 36 months
Description:
Fasting blood sugar will be performed using the the dextrostix
Measure:
Variation over time (percentage/year) of Forced Expiratory Volume in the 1st second (FEV1) of Group "COPD"
TimeFrame:
Baseline to post-interventions at 12 months
Description:
Forced Expiratory Volume in the 1st second (FEV1) will be assessed performing the spirometric test
Measure:
Variation over time (percentage/year) of Forced Expiratory Volume in the 1st second (FEV1) of Group "COPD"
TimeFrame:
Baseline to 24 months
Description:
Forced Expiratory Volume in the 1st second (FEV1) will be assessed performing the spirometric test
Measure:
Variation over time (percentage/year) of Forced Expiratory Volume in the 1st second (FEV1) of Group "COPD"
TimeFrame:
Baseline to 36 months
Description:
Forced Expiratory Volume in the 1st second (FEV1) will be assessed performing the spirometric test
Trial Information
NCT ID
NCT04986332
Status
Recruiting
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Last Updated
December 15, 2025