Multidimensional approach for patients with COPD and other chronic diseases

Clinical and Prognostic Evaluation of COPD Patients: Managing Multimorbidity Using a Multidimensional Approach

This study is testing a new program that combines exercise and therapy to see if it helps people with COPD and other chronic diseases feel better and stay out of the hospital.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 45 Years to 75 Years
• Sex: All
• Sponsor: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo (Academic / other)
• Locations: 1 site (Palermo)
• Trial ID: NCT04986332 on ClinicalTrials.gov

What this trial studies

The MACH Study aims to evaluate the effects of a multidimensional approach on patients with high complexity COPD, defined as having at least two chronic diseases. This includes a 24-week moderate-intensity physical activity program combined with a comprehensive therapeutic re-evaluation of the participants. The study will assess various outcomes such as the frequency of exacerbations, hospitalizations, quality of life, and survival over a 36-month follow-up period. Additionally, it will explore the relationship between comorbidity, polypharmacy, and clinical severity in COPD patients, particularly focusing on the impact of heart failure as a significant comorbidity.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with COPD and at least two other chronic diseases, or those with heart failure and COPD.

Not a fit: Patients with only COPD or heart failure without additional chronic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the management and quality of life for patients with COPD and multiple chronic conditions.

How similar studies have performed: While multidimensional approaches in chronic disease management have shown promise in other studies, this specific combination of interventions in COPD patients with high complexity is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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:

* 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)

Exclusion Criteria:

* 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;
* 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;

Where this trial is running

Palermo

• Domenico Di Raimondo — Palermo, Italy (Recruiting)

Study contacts

• Principal investigator: Domenico Di Raimondo — University of Palermo
• Study coordinator: Domenico Di Raimondo

Conditions Chronic Obstructive Pulmonary Disease; Heart Failure; Chronic Disease