Chronic Obstructive Pulmonary DiseaseMACHNCT04986332
Multidimensional Approach for COPD and High Complexity
A study testing Physical activity program and Global therapeutic remodeling in people with Chronic Obstructive Pulmonary Disease and Heart Failure, run by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo at 1 site in Italy.
Trial 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) Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Heart Failure, Chronic Disease
- What is being tested?
- Physical activity program and Global therapeutic remodeling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2021to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide signed and dated informed consent form;
- Willing to comply with all study procedures and be available for the duration of the study;
- COPD diagnosis (according to "Global Initiative for Chronic Obstructive Lung Disease" (GOLD) 2020 Guidelines) or HF diagnosis (according to European Society of Cardiology (ESC) 2016 Guidelines for the diagnosis and treatment of acute and chronic heart failure);
- Diagnosis at least two other chronic diseases, in addition to COPD (Group A) or HF (Group B). If COPD and HF diagnoses are both present in the same subject, COPD or HF will be considered as the index pathology in view of the clinical relevance and ergo, the participant will be included in the group A or in the group B;
- Healthy subjects exclusively for Group C;
- Chronic diseases are considered the following:
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- Type 1 or Type 2 Diabetes mellitus
- Essential hypertension
- Chronic Kidney Disease Stage 3b or worst (Glomerular Filtration Rate < 44 mL/min/1.73 m^2 estimated through the Cockcroft-Gault formule)
- Chronic Anemia of moderate level of lower (Haemoglobin levels ≤10.9 g/dl) according to World Health Organization (WHO) classification
- Chronic liver disease (every etiology)
- Obesity (Body Mass Index ≥ 30)
Who cannot join
- Active cigarette smoking;
- Need for continuous supportive oxygen therapy, regardless of the flow required;
- Distance covered during the 6 minutes walking test (6MWT) < 300 meters;
- Unstable angina pectoris or angina pectoris at rest, a history of cardiac arrest, "New York Heart Association" (NYHA) Class III or IV congestive heart failure or severe left ventricular systolic dysfunction (EF <30%), acute myocarditis, pericarditis or hypertrophic myocardiopathy, clinically significant aortic stenosis, cardiac defibrillator, heart transplant, history of aortic aneurysm of at least 7 cm in diameter or aortic aneurysm repair;
- Uncontrolled or partially controlled asthma despite optimal treatment; Sleep apnea syndrome; history of pulmonary fibrosis;
- Recent acute cardiac or cerebral event in the last six months;
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- Child-Pugh B/C cirrhosis;
- Body Mass Index ≥ 35;
- Evidence of any arrhythmia (uncontrolled atrial fibrillation (heart rate of 100 beats per minute or more), left bundle branch block or cardiac pacemaker, etc.) that contraindicates or makes unsafe the fulfilment of the regular physical activity program, assessed on the basis of the clinical history, documentation presented and clinical and instrumental evaluation carried out at the time of enrollment;
- Resting heart rate less than 45 beats per minute or greater than 100 beats per minute;
- History of uncontrolled or partially controlled high blood pressure despite optimal treatment;
- Regular physical activity practice (the level of habitual physical activity practiced will be ascertained by administering specific questionnaires. Only sedentary participants will be eligible);
- Inability to perform the 24-weeks physical activity program for any cause (muscle, joint, respiratory, neurological, vascular, diabetes complications);
- Any acute or chronic disease, already known at the time of enrollment, capable of altering systemic inflammation biomarkers and cytokine profile (e.g. sepsis, infections, immune-rheumatological diseases, hematological diseases, etc.).
- Any muscle condition, inflammatory or not, capable of altering muscular myokines' release (polymyositis, rheumatic polymyalgia, fibromyalgia);
- Acute bleeding at the time of enrollment or any anemia that would have been required urgent transfusion within the past three months;
- Solid or hematological neoplasia under active (at the time of enrollment) or recent (ended less than 6 months earlier) chemo-radiotherapy treatment at the time of enrollment;
- Current diagnosis of schizophrenia, other psychotic disorders or bipolar disorder uncontrolled or partially controlled despite optimal treatment;
- Self-report of alcohol or substance abuse within the past twelve months, current consumption of more than 14 alcoholic drinks per week, and/or current acute treatment or rehabilitation program for these problems;
- Severe cognitive impairment or anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study;
- Conditions not specifically mentioned above that may serve as criteria for exclusion at the discretion of the PI and study staff;
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Domenico Di Raimondo
Palermo, 90127
Domenico Di Raimondo, +390916552180, domenico.diraimondo@unipa.it
Domenico Di Raimondo, MD PhD
About this study
Official title: Clinical and Prognostic Evaluation of COPD Patients: Managing Multimorbidity Using a Multidimensional Approach
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)
Read the 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;
- Being tested
- Physical activity program, Global therapeutic remodeling
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity programBehavioural
24-weeks moderate-intensity physical activity program
Global therapeutic remodelingOther
Re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions
| Study group | Role | What they receive |
|---|---|---|
| GROUP "COPD" | Experimental | 100 participants, 50 males and 50 females with COPD and multiple chronic conditions Receives: Behavioral: Physical activity program; Other: Global therapeutic remodeling |
| GROUP "HF" | Active comparator | 100 participants, 50 males and 50 females with HF and multiple chronic conditions Receives: Behavioral: Physical activity program; Other: Global therapeutic remodeling |
| GROUP "HEALTHY PARTICIPANTS" | Active comparator | 100 healthy participants or "control group" which will be compared to Group A and Group B by age and sex Receives: Behavioral: Physical activity program; Other: Global therapeutic remodeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of COPD exacerbation of Group "COPD"
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;
Measured: Baseline to 12 months
Cumulative incidence of COPD exacerbation of Group "COPD"
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;
Measured: Baseline to 24 months
Cumulative incidence of COPD exacerbation of Group "COPD"
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;
Measured: Baseline to 36 months
Cumulative incidence of hospitalization for pneumonia of Group "COPD"
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.
Measured: Baseline to 12 months
Cumulative incidence of hospitalization for pneumonia of Group "COPD"
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.
Measured: Baseline to 24 months
Cumulative incidence of hospitalization for pneumonia of Group "COPD"
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.
Measured: Baseline to 36 months
Cumulative incidence of hospitalizations for any cause of Group A
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.
Measured: Baseline to 12 months
Cumulative incidence of hospitalizations for any cause of Group A
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.
Measured: Baseline to 24 months
Cumulative incidence of hospitalizations for any cause of Group A
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.
Measured: Baseline to 36 months
Mortality rate of Group "COPD"
The number of total deaths in the time frame of 12 months in Group "COPD"
Measured: Baseline to 12 months
Mortality rate of Group "COPD"
The number of total deaths in the time frame of 24 months in Group "COPD"
Measured: Baseline to 24 months
Mortality rate of Group "COPD"
The number of total deaths in the time frame of 36 months in Group "COPD"
Measured: Baseline to 36 months
Change over time from baseline in Mini Nutritional Assessment-Short Form total score of Group "COPD"
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.
Measured: Baseline to post-interventions at 12 months
Change over time from baseline in Mini Nutritional Assessment-Short Form total score of Group "COPD"
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.
Measured: Baseline to 24 months
Change over time from baseline in Mini Nutritional Assessment-Short Form total score of Group "COPD"
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.
Measured: Baseline to 36 months
Change over time from baseline in EQ-5D-3L of Group "COPD"
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)
Measured: Baseline to post-interventions at 12 months
Change over time from baseline in EQ-5D-3L of Group "COPD"
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)
Measured: Baseline to 24 months
Change over time from baseline in EQ-5D-3L of Group "COPD"
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)
Measured: Baseline to 36 months
Change over time from baseline in mMRC of Group "COPD"
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"
Measured: Baseline to post-interventions at 12 months
Change over time from baseline in mMRC of Group "COPD"
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"
Measured: Baseline to 24 months
Change over time from baseline in mMRC of Group "COPD"
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"
Measured: Baseline to 36 months
Change over time from baseline in CAT of Group "COPD"
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.
Measured: Baseline to post-interventions at 12 months
Change over time from baseline in CAT of Group "COPD"
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.
Measured: Baseline to 24 months
Change over time from baseline in CAT of Group "COPD"
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.
Measured: Baseline to 36 months
Change over time from baseline in Barthel Index of Group "COPD"
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.
Measured: Baseline to post interventions at 12 months
Change over time from baseline in Barthel Index of Group "COPD"
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.
Measured: Baseline to 24 months
Change over time from baseline in Barthel Index of Group "COPD"
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.
Measured: Baseline to 36 months
Change over time from baseline in 6-minutes Walking Test (6-mWT) of Group "COPD"
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
Measured: Baseline to post interventions at 12 months
Change over time from baseline in 6-minutes Walking Test (6-mWT) of Group "COPD"
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
Measured: Baseline to 24 months
Change over time from baseline in 6-minutes Walking Test (6-mWT) of Group "COPD"
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
Measured: Baseline to 36 months
Change over time from baseline in BODE Index of Group "COPD"
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.
Measured: Baseline to post-interventions at 12 months
Change over time from baseline in BODE Index of Group "COPD"
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.
Measured: Baseline to 24 months
Change over time from baseline in BODE Index of Group "COPD"
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.
Measured: Baseline to 36 months
Change over time from baseline in 24-hour average systolic and diastolic pressures of Group "COPD"
24-hour average systolic and diastolic pressures will be assessed performing a 24-hour Ambulatory Blood Pressure Monitoring.
Measured: Baseline to post-interventions at 12 months
Change over time from baseline in 24-hour average systolic and diastolic pressures of Group "COPD"
24-hour average systolic and diastolic pressures will be assessed performing a 24-hour Ambulatory Blood Pressure Monitoring.
Measured: Baseline to 24 months
Change over time from baseline in 24-hour average systolic and diastolic pressures of Group "COPD"
24-hour average systolic and diastolic pressures will be assessed performing a 24-hour Ambulatory Blood Pressure Monitoring.
Measured: Baseline to 36 months
Change over time from baseline in heart rate variability of Group "COPD"
Heart rate variability will be assessed performing a 24-ECG Holter
Measured: Baseline to post-interventions at 12 months
Change over time from baseline in heart rate variability of Group "COPD"
Heart rate variability will be assessed performing a 24-ECG Holter
Measured: Baseline to 24 months
Change over time from baseline in heart rate variability of Group "COPD"
Heart rate variability will be assessed performing a 24-ECG Holter
Measured: Baseline to 36 months
Change over time from baseline in fasting blood sugar of Group "COPD"
Fasting blood sugar will be performed using the the dextrostix
Measured: Baseline to post-interventions at 12 months
Change over time from baseline in fasting blood sugar of Group "COPD"
Fasting blood sugar will be performed using the the dextrostix
Measured: Baseline to 24 months
Change over time from baseline in fasting blood sugar of Group "COPD"
Fasting blood sugar will be performed using the the dextrostix
Measured: Baseline to 36 months
Variation over time (percentage/year) of Forced Expiratory Volume in the 1st second (FEV1) of Group "COPD"
Forced Expiratory Volume in the 1st second (FEV1) will be assessed performing the spirometric test
Measured: Baseline to post-interventions at 12 months
Variation over time (percentage/year) of Forced Expiratory Volume in the 1st second (FEV1) of Group "COPD"
Forced Expiratory Volume in the 1st second (FEV1) will be assessed performing the spirometric test
Measured: Baseline to 24 months
Variation over time (percentage/year) of Forced Expiratory Volume in the 1st second (FEV1) of Group "COPD"
Forced Expiratory Volume in the 1st second (FEV1) will be assessed performing the spirometric test
Measured: Baseline to 36 months
Secondary outcomes (51)
Change over time from baseline on the circulating levels of Interleukin-6 (IL-6) (pg/mL) of Group "COPD"
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 circulating levels of IL-6 (pg/mL) of Group "COPD"
Measured: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of Interleukin-6 (IL-6) (pg/mL) of Group "COPD"
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 circulating levels of IL-6 (pg/mL) of Group "COPD"
Measured: Baseline to 24 months
Change over time from baseline on the circulating levels of Interleukin-6 (IL-6) (pg/mL) of Group "COPD"
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 circulating levels of IL-6 (pg/mL) of Group "COPD"
Measured: Baseline to 36 months
Change over time from baseline on the circulating levels of IL-8 (pg/mL) of Group "COPD"
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 circulating levels of IL-8 (pg/mL) of Group "COPD"
Measured: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of IL-8 (pg/mL) of Group "COPD"
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 circulating levels of IL-8 (pg/mL) of Group "COPD"
Measured: Baseline to 24 months
Change over time from baseline on the circulating levels of IL-8 (pg/mL) of Group "COPD"
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 circulating levels of IL-8 (pg/mL) of Group "COPD"
Measured: Baseline to 36 months
Change over time from baseline on the circulating levels of IL-10 (pg/mL) of Group "COPD"
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 circulating levels of IL-10 (pg/mL) of Group "COPD"
Measured: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of IL-10 (pg/mL) of Group "COPD"
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 circulating levels of IL-10 (pg/mL) of Group "COPD"
Measured: Baseline to 24 months
Change over time from baseline on the circulating levels of IL-10 (pg/mL) of Group "COPD"
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 circulating levels of IL-10 (pg/mL) of Group "COPD"
Measured: Baseline to 36 months
Change over time from baseline on the circulating levels of IL-15 (pg/mL) of Group "COPD"
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 circulating levels of IL-15 (pg/mL) of Group "COPD"
Measured: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of IL-15 (pg/mL) of Group "COPD"
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 circulating levels of IL-15 (pg/mL) of Group "COPD"
Measured: Baseline to 24 months
Change over time from baseline on the circulating levels of IL-15 (pg/mL) of Group "COPD"
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 circulating levels of IL-15 (pg/mL) of Group "COPD"
Measured: Baseline to 36 months
Change over time from baseline on the circulating levels of Tumor Necrosis Factor- α (TNF-α) (pg/mL) of Group "COPD"
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 circulating levels of Tumor Necrosis Factor- α (TNF-α) (pg/mL) of Group "COPD"
Measured: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of Tumor Necrosis Factor- α (TNF-α) (pg/mL) of Group "COPD"
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 circulating levels of Tumor Necrosis Factor- α (TNF-α) (pg/mL) of Group "COPD"
Measured: Baseline to 24 months
Change over time from baseline on the circulating levels of Tumor Necrosis Factor- α (TNF-α) (pg/mL) of Group "COPD"
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 circulating levels of Tumor Necrosis Factor- α (TNF-α) (pg/mL) of Group "COPD"
Measured: Baseline to 36 months
Change over time from baseline on the circulating levels of IL-1β (pg/mL) of Group "COPD"
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 circulating levels of IL-1β (pg/mL) of Group "COPD"
Measured: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of IL-1β (pg/mL) of Group "COPD"
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 circulating levels of IL-1β (pg/mL) of Group "COPD"
Measured: Baseline to 24 months
Change over time from baseline on the circulating levels of IL-1β (pg/mL) of Group "COPD"
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 circulating levels of IL-1β (pg/mL) of Group "COPD"
Measured: Baseline to 36 months
Change over time from baseline on the circulating levels of IL-1ra (pg/mL) of Group "COPD"
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 circulating levels of IL-1ra (pg/mL) of Group "COPD"
Measured: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of IL-1ra (pg/mL) of Group "COPD"
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 circulating levels of IL-1ra (pg/mL) of Group "COPD"
Measured: Baseline to 24 months
Change over time from baseline on the circulating levels of IL-1ra (pg/mL) of Group "COPD"
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 circulating levels of IL-1ra (pg/mL) of Group "COPD"
Measured: Baseline to 36 months
Change over time from baseline on the circulating levels of soluble Tumor Necrosis Factor receptors (sTNFr) (ng/mL) of Group "COPD"
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 circulating levels of soluble Tumor Necrosis Factor receptors (sTNFr) (ng/mL) of Group "COPD"
Measured: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of soluble Tumor Necrosis Factor receptors (sTNFr) (ng/mL) of Group "COPD"
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 circulating levels of soluble Tumor Necrosis Factor receptors (sTNFr) (ng/mL) of Group "COPD"
Measured: Baseline to 24 months
Change over time from baseline on the circulating levels of soluble Tumor Necrosis Factor receptors (sTNFr) (ng/mL) of Group "COPD"
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 circulating levels of soluble Tumor Necrosis Factor receptors (sTNFr) (ng/mL) of Group "COPD"
Measured: Baseline to 36 months
Change over time from baseline on the circulating levels of Vascular Endothelial Growth Factor (VEGF) (pg/mL) of Group "COPD"
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 circulating levels of Vascular Endothelial Growth Factor (VEGF) (pg/mL) of Group "COPD"
Measured: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of Vascular Endothelial Growth Factor (VEGF) (pg/mL) of Group "COPD"
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 circulating levels of Vascular Endothelial Growth Factor (VEGF) (pg/mL) of Group "COPD"
Measured: Baseline to 24 months
Change over time from baseline on the circulating levels of Vascular Endothelial Growth Factor (VEGF) (pg/mL) of Group "COPD"
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 circulating levels of Vascular Endothelial Growth Factor (VEGF) (pg/mL) of Group "COPD"
Measured: Baseline to 36 months
Change over time from baseline on the circulating levels of Brain Derived Neurotrophic Factor (BDNF) (ng/mL) of Group "COPD"
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 circulating levels of Brain Derived Neurotrophic Factor (BDNF) (ng/mL) of Group "COPD"
Measured: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of Brain Derived Neurotrophic Factor (BDNF) (ng/mL) of Group "COPD"
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 circulating levels of Brain Derived Neurotrophic Factor (BDNF) (ng/mL) of Group "COPD"
Measured: Baseline to 24 months
Change over time from baseline on the circulating levels of Brain Derived Neurotrophic Factor (BDNF) (ng/mL) of Group "COPD"
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 circulating levels of Brain Derived Neurotrophic Factor (BDNF) (ng/mL) of Group "COPD"
Measured: Baseline to 36 months
Change over time from baseline on the circulating levels of Insulin-like growth factor 1 (IGF-1) (ng/mL) of Group "COPD"
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 circulating levels of Insulin-like growth factor 1 (IGF-1) (ng/mL) of Group "COPD"
Measured: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of Insulin-like growth factor 1 (IGF-1) (ng/mL) of Group "COPD"
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 circulating levels of Insulin-like growth factor 1 (IGF-1) (ng/mL) of Group "COPD"
Measured: Baseline to 24 months
Change over time from baseline on the circulating levels of Insulin-like growth factor 1 (IGF-1) (ng/mL) of Group "COPD"
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 circulating levels of Insulin-like growth factor 1 (IGF-1) (ng/mL) of Group "COPD"
Measured: Baseline to 36 months
Change over time from baseline on the circulating levels of Transforming Growth Factor-β (TGF-β) (ng/mL) of Group "COPD"
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 circulating levels of Transforming Growth Factor-β (TGF-β) (ng/mL) of Group "COPD"
Measured: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of Transforming Growth Factor-β (TGF-β) (ng/mL) of Group "COPD"
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 circulating levels of Transforming Growth Factor-β (TGF-β) (ng/mL) of Group "COPD"
Measured: Baseline to 24 months
Change over time from baseline on the circulating levels of Transforming Growth Factor-β (TGF-β) (ng/mL) of Group "COPD"
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 circulating levels of Transforming Growth Factor-β (TGF-β) (ng/mL) of Group "COPD"
Measured: Baseline to 36 months
Change over time from baseline on the circulating levels of Irisin (ng/mL) of Group "COPD"
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 circulating levels of Irisin (ng/mL) of Group "COPD"
Measured: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of Irisin (ng/mL) of Group "COPD"
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 circulating levels of Irisin (ng/mL) of Group "COPD"
Measured: Baseline to 24 months
Change over time from baseline on the circulating levels of Irisin (ng/mL) of Group "COPD"
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 circulating levels of Irisin (ng/mL) of Group "COPD"
Measured: Baseline to 36 months
Change over time from baseline on the circulating levels of Myostatin (pg/mL) of Group "COPD"
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 circulating levels of Myostatin (pg/mL) of Group "COPD"
Measured: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of Myostatin (pg/mL) of Group "COPD"
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 circulating levels of Myostatin (pg/mL) of Group "COPD"
Measured: Baseline to 24 months
Change over time from baseline on the circulating levels of Myostatin (pg/mL) of Group "COPD"
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 circulating levels of Myostatin (pg/mL) of Group "COPD"
Measured: Baseline to 36 months
Change over time from baseline on the circulating levels of Follistatin (pg/mL) of Group "COPD"
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 circulating levels of Follistatin (pg/mL) of Group "COPD"
Measured: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of Follistatin (pg/mL) of Group "COPD"
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 circulating levels of Follistatin (pg/mL) of Group "COPD"
Measured: Baseline to 24 months
Change over time from baseline on the circulating levels of Follistatin (pg/mL) of Group "COPD"
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 circulating levels of Follistatin (pg/mL) of Group "COPD"
Measured: Baseline to 36 months
Change over time from baseline on the circulating levels of β-aminoisobutyric acid (BAIBA) (ng/mL) of Group "COPD"
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 circulating levels of β-aminoisobutyric acid (BAIBA) (ng/mL) of Group "COPD"
Measured: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of β-aminoisobutyric acid (BAIBA) (ng/mL) of Group "COPD"
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 circulating levels of β-aminoisobutyric acid (BAIBA) (ng/mL) of Group "COPD"
Measured: Baseline to 24 months
Change over time from baseline on the circulating levels of β-aminoisobutyric acid (BAIBA) (ng/mL) of Group "COPD"
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 circulating levels of β-aminoisobutyric acid (BAIBA) (ng/mL) of Group "COPD"
Measured: Baseline to 36 months
Change over time from baseline in miRNAs serum expression of Group "COPD"
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 in miRNAs serum expression of Group "COPD"
- miRNA-1,
- miRNA-21,
- miRNA-210,
- miRNA-221,
- miRNA-223,
- miRNA-1274a,
- miRNA-101,
- miRNA-144,
- miRNA-133a,
- miRNA-133b,
- miRNA-206,
- miRNA-208a,
- miRNA-208b,
- miRNA-499,
- miRNA-532
- miRNA-181a
Measured: Baseline to post-interventions at 12 months
Change over time from baseline in miRNAs serum expression of Group "COPD"
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 in miRNAs serum expression of Group "COPD"
- miRNA-1,
- miRNA-21,
- miRNA-210,
- miRNA-221,
- miRNA-223,
- miRNA-1274a,
- miRNA-101,
- miRNA-144,
- miRNA-133a,
- miRNA-133b,
- miRNA-206,
- miRNA-208a,
- miRNA-208b,
- miRNA-499,
- miRNA-532
- miRNA-181a
Measured: Baseline to 24 months
Change over time from baseline in miRNAs serum expression of Group "COPD"
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 in miRNAs serum expression of Group "COPD"
- miRNA-1,
- miRNA-21,
- miRNA-210,
- miRNA-221,
- miRNA-223,
- miRNA-1274a,
- miRNA-101,
- miRNA-144,
- miRNA-133a,
- miRNA-133b,
- miRNA-206,
- miRNA-208a,
- miRNA-208b,
- miRNA-499,
- miRNA-532
- miRNA-181a
Measured: Baseline to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Sep 2021
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Three parallel non-randomized groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Domenico Di Raimondo, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
- Investigators
- Domenico Di Raimondo, Principal investigator, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986332
- Sponsor's protocol ID
- MACH Study
- Acronym
- MACH
- Status last verified
- Feb 2023
- First submitted
- 9 Jul 2021
- Last updated
- 22 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Prognostic Evaluation of COPD Patients: Managing Multimorbidity Using a Multidimensional Approach
- ClinicalTrials.gov ID
- NCT04986332
- Acronym / sponsor ID
- MACH / MACH Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone PalermoUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three parallel non-randomized groups
| Arm | Type | Receives |
|---|---|---|
| GROUP "COPD" | Experimental | Behavioral: Physical activity program, Other: Global therapeutic remodeling100 participants, 50 males and 50 females with COPD and multiple chronic conditions |
| GROUP "HF" | Active comparator | Behavioral: Physical activity program, Other: Global therapeutic remodeling100 participants, 50 males and 50 females with HF and multiple chronic conditions |
| GROUP "HEALTHY PARTICIPANTS" | Active comparator | Behavioral: Physical activity program, Other: Global therapeutic remodeling100 healthy participants or "control group" which will be compared to Group A and Group B by age and sex |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provide signed and dated informed consent form;
- Willing to comply with all study procedures and be available for the duration of the study;
- COPD diagnosis (according to "Global Initiative for Chronic Obstructive Lung Disease" (GOLD) 2020 Guidelines) or HF diagnosis (according to European Society of Cardiology (ESC) 2016 Guidelines for the diagnosis and treatment of acute and chronic heart failure);
- Diagnosis at least two other chronic diseases, in addition to COPD (Group A) or HF (Group B). If COPD and HF diagnoses are both present in the same subject, COPD or HF will be considered as the index pathology in view of the clinical relevance and ergo, the participant will be included in the group A or in the group B;
- Healthy subjects exclusively for Group C;
Key exclusion criteria (21 listed)
- Active cigarette smoking;
- Need for continuous supportive oxygen therapy, regardless of the flow required;
- Distance covered during the 6 minutes walking test (6MWT) < 300 meters;
- Unstable angina pectoris or angina pectoris at rest, a history of cardiac arrest, "New York Heart Association" (NYHA) Class III or IV congestive heart failure or severe left ventricular systolic dysfunction (EF <30%), acute myocarditis, pericarditis or hypertrophic myocardiopathy, clinically significant aortic stenosis, cardiac defibrillator, heart transplant, history of aortic aneurysm of at least 7 cm in diameter or aortic aneurysm repair;
- Uncontrolled or partially controlled asthma despite optimal treatment; Sleep apnea syndrome; history of pulmonary fibrosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity program24-weeks moderate-intensity physical activity program | Behavioural | GROUP "COPD", GROUP "HEALTHY PARTICIPANTS", GROUP "HF" |
| Global therapeutic remodelingRe-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions | Other | GROUP "COPD", GROUP "HEALTHY PARTICIPANTS", GROUP "HF" |
Primary outcome
Cumulative incidence of COPD exacerbation of Group "COPD"
Time frame: Baseline to 12 months
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;
Cumulative incidence of COPD exacerbation of Group "COPD"
Time frame: Baseline to 24 months
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;
Cumulative incidence of COPD exacerbation of Group "COPD"
Time frame: Baseline to 36 months
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;
Cumulative incidence of hospitalization for pneumonia of Group "COPD"
Time frame: Baseline to 12 months
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.
Cumulative incidence of hospitalization for pneumonia of Group "COPD"
Time frame: Baseline to 24 months
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.
Cumulative incidence of hospitalization for pneumonia of Group "COPD"
Time frame: Baseline to 36 months
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.
Cumulative incidence of hospitalizations for any cause of Group A
Time frame: Baseline to 12 months
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.
Cumulative incidence of hospitalizations for any cause of Group A
Time frame: Baseline to 24 months
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.
Cumulative incidence of hospitalizations for any cause of Group A
Time frame: Baseline to 36 months
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.
Mortality rate of Group "COPD"
Time frame: Baseline to 12 months
The number of total deaths in the time frame of 12 months in Group "COPD"
Mortality rate of Group "COPD"
Time frame: Baseline to 24 months
The number of total deaths in the time frame of 24 months in Group "COPD"
Mortality rate of Group "COPD"
Time frame: Baseline to 36 months
The number of total deaths in the time frame of 36 months in Group "COPD"
Change over time from baseline in Mini Nutritional Assessment-Short Form total score of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
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.
Change over time from baseline in Mini Nutritional Assessment-Short Form total score of Group "COPD"
Time frame: Baseline to 24 months
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.
Change over time from baseline in Mini Nutritional Assessment-Short Form total score of Group "COPD"
Time frame: Baseline to 36 months
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.
Change over time from baseline in EQ-5D-3L of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
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)
Change over time from baseline in EQ-5D-3L of Group "COPD"
Time frame: Baseline to 24 months
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)
Change over time from baseline in EQ-5D-3L of Group "COPD"
Time frame: Baseline to 36 months
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)
Change over time from baseline in mMRC of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
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"
Change over time from baseline in mMRC of Group "COPD"
Time frame: Baseline to 24 months
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"
Change over time from baseline in mMRC of Group "COPD"
Time frame: Baseline to 36 months
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"
Change over time from baseline in CAT of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
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.
Change over time from baseline in CAT of Group "COPD"
Time frame: Baseline to 24 months
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.
Change over time from baseline in CAT of Group "COPD"
Time frame: Baseline to 36 months
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.
Change over time from baseline in Barthel Index of Group "COPD"
Time frame: Baseline to post interventions at 12 months
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.
Change over time from baseline in Barthel Index of Group "COPD"
Time frame: Baseline to 24 months
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.
Change over time from baseline in Barthel Index of Group "COPD"
Time frame: Baseline to 36 months
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.
Change over time from baseline in 6-minutes Walking Test (6-mWT) of Group "COPD"
Time frame: Baseline to post interventions at 12 months
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
Change over time from baseline in 6-minutes Walking Test (6-mWT) of Group "COPD"
Time frame: Baseline to 24 months
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
Change over time from baseline in 6-minutes Walking Test (6-mWT) of Group "COPD"
Time frame: Baseline to 36 months
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
Change over time from baseline in BODE Index of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
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.
Change over time from baseline in BODE Index of Group "COPD"
Time frame: Baseline to 24 months
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.
Change over time from baseline in BODE Index of Group "COPD"
Time frame: Baseline to 36 months
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.
Change over time from baseline in 24-hour average systolic and diastolic pressures of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
24-hour average systolic and diastolic pressures will be assessed performing a 24-hour Ambulatory Blood Pressure Monitoring.
Change over time from baseline in 24-hour average systolic and diastolic pressures of Group "COPD"
Time frame: Baseline to 24 months
24-hour average systolic and diastolic pressures will be assessed performing a 24-hour Ambulatory Blood Pressure Monitoring.
Change over time from baseline in 24-hour average systolic and diastolic pressures of Group "COPD"
Time frame: Baseline to 36 months
24-hour average systolic and diastolic pressures will be assessed performing a 24-hour Ambulatory Blood Pressure Monitoring.
Change over time from baseline in heart rate variability of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
Heart rate variability will be assessed performing a 24-ECG Holter
Change over time from baseline in heart rate variability of Group "COPD"
Time frame: Baseline to 24 months
Heart rate variability will be assessed performing a 24-ECG Holter
Change over time from baseline in heart rate variability of Group "COPD"
Time frame: Baseline to 36 months
Heart rate variability will be assessed performing a 24-ECG Holter
Change over time from baseline in fasting blood sugar of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
Fasting blood sugar will be performed using the the dextrostix
Change over time from baseline in fasting blood sugar of Group "COPD"
Time frame: Baseline to 24 months
Fasting blood sugar will be performed using the the dextrostix
Change over time from baseline in fasting blood sugar of Group "COPD"
Time frame: Baseline to 36 months
Fasting blood sugar will be performed using the the dextrostix
Variation over time (percentage/year) of Forced Expiratory Volume in the 1st second (FEV1) of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
Forced Expiratory Volume in the 1st second (FEV1) will be assessed performing the spirometric test
Variation over time (percentage/year) of Forced Expiratory Volume in the 1st second (FEV1) of Group "COPD"
Time frame: Baseline to 24 months
Forced Expiratory Volume in the 1st second (FEV1) will be assessed performing the spirometric test
Variation over time (percentage/year) of Forced Expiratory Volume in the 1st second (FEV1) of Group "COPD"
Time frame: Baseline to 36 months
Forced Expiratory Volume in the 1st second (FEV1) will be assessed performing the spirometric test
51 secondary outcomes
Change over time from baseline on the circulating levels of Interleukin-6 (IL-6) (pg/mL) of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of Interleukin-6 (IL-6) (pg/mL) of Group "COPD"
Time frame: Baseline to 24 months
Change over time from baseline on the circulating levels of Interleukin-6 (IL-6) (pg/mL) of Group "COPD"
Time frame: Baseline to 36 months
Change over time from baseline on the circulating levels of IL-8 (pg/mL) of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of IL-8 (pg/mL) of Group "COPD"
Time frame: Baseline to 24 months
Change over time from baseline on the circulating levels of IL-8 (pg/mL) of Group "COPD"
Time frame: Baseline to 36 months
Change over time from baseline on the circulating levels of IL-10 (pg/mL) of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of IL-10 (pg/mL) of Group "COPD"
Time frame: Baseline to 24 months
Change over time from baseline on the circulating levels of IL-10 (pg/mL) of Group "COPD"
Time frame: Baseline to 36 months
Change over time from baseline on the circulating levels of IL-15 (pg/mL) of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of IL-15 (pg/mL) of Group "COPD"
Time frame: Baseline to 24 months
Change over time from baseline on the circulating levels of IL-15 (pg/mL) of Group "COPD"
Time frame: Baseline to 36 months
Change over time from baseline on the circulating levels of Tumor Necrosis Factor- α (TNF-α) (pg/mL) of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of Tumor Necrosis Factor- α (TNF-α) (pg/mL) of Group "COPD"
Time frame: Baseline to 24 months
Change over time from baseline on the circulating levels of Tumor Necrosis Factor- α (TNF-α) (pg/mL) of Group "COPD"
Time frame: Baseline to 36 months
Change over time from baseline on the circulating levels of IL-1β (pg/mL) of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of IL-1β (pg/mL) of Group "COPD"
Time frame: Baseline to 24 months
Change over time from baseline on the circulating levels of IL-1β (pg/mL) of Group "COPD"
Time frame: Baseline to 36 months
Change over time from baseline on the circulating levels of IL-1ra (pg/mL) of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of IL-1ra (pg/mL) of Group "COPD"
Time frame: Baseline to 24 months
Change over time from baseline on the circulating levels of IL-1ra (pg/mL) of Group "COPD"
Time frame: Baseline to 36 months
Change over time from baseline on the circulating levels of soluble Tumor Necrosis Factor receptors (sTNFr) (ng/mL) of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of soluble Tumor Necrosis Factor receptors (sTNFr) (ng/mL) of Group "COPD"
Time frame: Baseline to 24 months
Change over time from baseline on the circulating levels of soluble Tumor Necrosis Factor receptors (sTNFr) (ng/mL) of Group "COPD"
Time frame: Baseline to 36 months
Change over time from baseline on the circulating levels of Vascular Endothelial Growth Factor (VEGF) (pg/mL) of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of Vascular Endothelial Growth Factor (VEGF) (pg/mL) of Group "COPD"
Time frame: Baseline to 24 months
Change over time from baseline on the circulating levels of Vascular Endothelial Growth Factor (VEGF) (pg/mL) of Group "COPD"
Time frame: Baseline to 36 months
Change over time from baseline on the circulating levels of Brain Derived Neurotrophic Factor (BDNF) (ng/mL) of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of Brain Derived Neurotrophic Factor (BDNF) (ng/mL) of Group "COPD"
Time frame: Baseline to 24 months
Change over time from baseline on the circulating levels of Brain Derived Neurotrophic Factor (BDNF) (ng/mL) of Group "COPD"
Time frame: Baseline to 36 months
Change over time from baseline on the circulating levels of Insulin-like growth factor 1 (IGF-1) (ng/mL) of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of Insulin-like growth factor 1 (IGF-1) (ng/mL) of Group "COPD"
Time frame: Baseline to 24 months
Change over time from baseline on the circulating levels of Insulin-like growth factor 1 (IGF-1) (ng/mL) of Group "COPD"
Time frame: Baseline to 36 months
Change over time from baseline on the circulating levels of Transforming Growth Factor-β (TGF-β) (ng/mL) of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of Transforming Growth Factor-β (TGF-β) (ng/mL) of Group "COPD"
Time frame: Baseline to 24 months
Change over time from baseline on the circulating levels of Transforming Growth Factor-β (TGF-β) (ng/mL) of Group "COPD"
Time frame: Baseline to 36 months
Change over time from baseline on the circulating levels of Irisin (ng/mL) of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
Change over time from baseline on the circulating levels of Irisin (ng/mL) of Group "COPD"
Time frame: Baseline to 24 months
Change over time from baseline on the circulating levels of Irisin (ng/mL) of Group "COPD"
Time frame: Baseline to 36 months
Change over time from baseline on the circulating levels of Myostatin (pg/mL) of Group "COPD"
Time frame: Baseline to post-interventions at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Domenico Di Raimondo principal investigator
University of Palermo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity program and Global therapeutic remodeling in people with Chronic Obstructive Pulmonary Disease and Heart Failure, run by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Domenico Di Raimondo (+390916552180, domenico.diraimondo@unipa.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of COPD exacerbation of Group "COPD" (time frame: Baseline to 12 months). The study lists 45 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.