Lumezzane

Researchers are conducting an observational, prospective, multicenter study in Italian cardiology centers to evaluate how well patients with Heart Failure with Reduced Ejection Fraction (HFrEF) follow guideline-recommended treatments. The study also aims to assess the safety of these treatments, monitor treatment patterns in patients with acute heart failure, and observe treatment approaches in all chronic heart failure patients regardless of their ejection fraction levels. The study involves two phases of educational interventions and data collection. Initially, healthcare providers will receive education on guideline recommendations and treatment patterns, followed by 3 months of patient data collection or up to 30 consecutive patients with chronic or acute heart failure. After 6 months, treatment modifications and outcomes will be evaluated. Then, a second educational session will highlight gaps between guidelines and practice, followed by another 3 months of data collection. Patients will be followed for 12 months total, with ongoing monitoring of treatment changes and outcomes. Participants will be assessed at enrollment and during the follow-up periods through clinical evaluations and data collection on treatment adherence and safety. The main outcome measured is adherence to guideline-directed medical therapies over 6 months. The study includes evaluations at 6 and 12 months after enrollment, with close monitoring of treatment patterns and patient health status throughout the study duration.

Researchers are evaluating patients who have experienced athero-thrombotic events such as coronary artery disease, cerebrovascular disease, or peripheral artery disease. The study aims to assess how well patients follow guideline recommendations, particularly focusing on improving cholesterol levels and other modifiable risk factors to reduce the chance of cardiovascular event recurrence. This observational and prospective study takes place across multiple cardiology centers in Italy to represent a broad patient population. The study includes several phases starting with an educational intervention to discuss guideline recommendations for secondary prevention. Following this, data is collected for three months or until 30 patients with documented cardiovascular conditions are enrolled, using a web-based case record form that identifies when guidelines are not followed and records reasons for non-adherence. After six months, primary and secondary outcomes are evaluated. A second educational intervention then shares findings from the first phase to highlight gaps in clinical practice, followed by another three-month data collection period and a further six-month outcome assessment. Finally, all patients are followed for 12 months to monitor longer-term results. Participants provide informed consent and are monitored through data collection forms that track adherence to guidelines and clinical outcomes. The main outcome measured is adherence to cholesterol management guidelines over six months. Additional assessments include adherence to recommendations for other cardiovascular risk factors. Throughout the study, researchers gather data to understand how guideline adherence affects patient health and to identify barriers to following best practices, with continuous follow-up over a year to evaluate sustained effects.

Chronic Obstructive Pulmonary Disease (COPD) causes exercise intolerance and significant disability due to symptoms like breathlessness and fatigue, which impair daily activities. Pulmonary rehabilitation (PR), especially exercise-based, is key in managing COPD by improving exercise tolerance, reducing symptoms, and enhancing quality of life. This study aims to compare whether combined arm and leg training is more effective than standard lower limb training alone in improving activity of daily living (ADL) performance as measured by the GLITTRE test. Participants will be randomly assigned to one of two rehabilitation programs lasting 14 daily sessions of 90 minutes each. The lower limbs (LL) group will perform 60 minutes of stationary cycling for legs and 30 minutes of strengthening exercises. The lower plus upper limbs (L+UL) group will do 30 minutes of leg cycling, 30 minutes of arm-ergometer training, and 30 minutes of strengthening exercises for both upper and lower limbs. All sessions will be supervised by a physiotherapist, and training intensity will be progressively adjusted based on individual effort. During the study, researchers will collect clinical and lung function data at baseline and assess quality of life and functional ability before and after the program. The primary measure is the change in time to complete the GLITTRE test up to 16 days after randomization. Secondary outcomes include effort tolerance of upper and lower limbs and energy cost of walking. Safety, symptoms, and disability will also be monitored throughout the rehabilitation period.

Researchers are evaluating the effects of adding a therapeutic dose of oxygen during exercise on patients with chronic respiratory failure or exertional hypoxemia caused by chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD). This multicenter crossover trial aims to assess exercise performance, gas exchange, heart rate, symptom perception, and the ease of performing exercise in patients hospitalized in specialized pulmonary rehabilitation centers. The study also seeks to understand differences in responses among different disease groups and to improve oxygen therapy prescriptions during exertion. Participants will perform two 6-minute walk tests under different oxygen conditions in random order: one using their usual oxygen flow prescribed at rest or room air for those with exertional hypoxemia, and the other with supplemental oxygen set at double the resting flow rate or 2 liters per minute for those with exertional hypoxemia. The tests will be done at least 3 hours apart and within 24 hours. Oxygen is delivered through nasal cannula, and patients will carry oxygen in a stroller or similar device during the walks. The study includes three groups based on diagnosis and oxygen needs: COPD with exertional hypoxemia, COPD with chronic respiratory failure, and ILD with chronic respiratory failure. During the study, researchers will measure walking distance, oxygen saturation, heart rate, blood pressure, and symptom scales before, during, and after each walk. Participants will also complete a questionnaire about the ease of performance. The main outcome is the change in distance walked with supplemental oxygen compared to usual oxygen. Data analysis will explore clinical factors related to oxygen response, aiming to identify which patients benefit most and to inform better oxygen therapy dosing during exercise. The study plans to enroll 114 patients and follow strict statistical methods for comparison.

Researchers are evaluating rehabilitation approaches for people recovering from a COPD exacerbation, which often causes severe leg muscle weakness and difficulty with daily activities. The study compares a high-intensity maximal strength training (MST) program with a traditional high-intensity endurance training program. The goal is to find out if MST is easier to tolerate, especially regarding breathlessness, and if it can improve muscle strength, efficiency, and exercise tolerance as well or better than endurance training. Participants are randomly assigned to one of two groups. The MST group performs high-intensity strength training on a leg press machine, doing four sets of five repetitions at 90-95% of their maximum strength, with two-minute rests between sets and weight increases as tolerated. They also do low-intensity cycling at 20% of their maximum workload. The endurance group cycles at 70% of their maximum workload for 25 minutes, increasing intensity when breathlessness is mild, and also performs low-intensity leg press strength training without progression. Both groups train five days a week for 15 sessions, after which they continue with a combined program until discharge. During the study, participants undergo assessments including breathlessness during daily activities measured by the Barthel Dyspnea Index, six-minute walk tests, fatigue scales, muscle strength and ultrasound exams, and questionnaires on disease impact and quality of life. Neuromuscular fatigue and walking efficiency are measured in those who complete the study. Satisfaction with the training programs is evaluated after the last session. The study monitors safety and adherence throughout, with a total participation period covering up to discharge after rehabilitation.

Researchers are investigating the impact of different types of pain and autonomic symptoms in patients diagnosed with Parkinson's disease (PD) and multiple system atrophy (MSA). The study focuses on evaluating how prevalent pain and autonomic symptoms are in these conditions, and how they affect patients' quality of life. It also aims to assess the effect of rehabilitation on these symptoms by comparing patients with PD and MSA. This observational study is conducted at the Istituti Clinici Scientifici Maugeri Centers and includes both inpatients and outpatients. All participants will receive a neurological examination and undergo a personalized rehabilitation program designed to improve strength, coordination, balance, endurance, and daily living activities. Alongside rehabilitation, clinical scales will be used to assess disease stage, severity, motor and non-motor symptoms, cognitive function, depression, quality of life, autonomic dysfunction, and pain. The rehabilitation program allows evaluation over time to observe any significant changes in clinical parameters. Participants will be closely monitored before and after the rehabilitation program, with outcome measures including the prevalence and characterization of pain at recruitment and after about 30 days of rehabilitation. Researchers will collect data through clinical scales and neurological examinations to understand the impact of pain and autonomic symptoms on disability and quality of life. This comprehensive evaluation aims to guide clinicians in managing patient disability and refining rehabilitation strategies to improve patient outcomes.

Researchers are evaluating whether adding music to rehabilitation training can improve exercise tolerance in people with chronic obstructive pulmonary disease (COPD) and chronic respiratory failure (CRF). This study compares the effects of music-supported training versus usual rehabilitation without music, focusing on endurance, fatigue, and breathlessness. Music therapy is known to help in various medical settings by improving psychological and physical symptoms, and this trial aims to assess its impact specifically in COPD and CRF patients. Participants will be randomly assigned to one of two groups: a music-supported (MS) group and a control (C) group. The MS group will perform their usual training on a cycle ergometer while listening to music chosen from four styles (rock, modern, jazz, classical) with a steady rhythm matching the pedaling pace. The C group will perform supervised exercise sessions without music, with training intensity adjusted based on perceived effort. Both groups will complete 12 to 14 sessions over several weeks, each session lasting about 30 minutes plus warm-up and recovery. During the study, participants will undergo evaluations including lung function tests, a 6-minute walk test measuring fatigue and breathlessness, muscle strength assessments, blood gas analysis, and exercise capacity tests on a cycle ergometer. Heart rate, oxygen saturation, and perceived exertion will be monitored before and after each session. The main outcome is the change in effort tolerance measured by the 6-minute walk test over the program lasting up to 3 weeks. Researchers will also track reasons for withdrawal and analyze factors that predict improvement.

This research focuses on patients with Chronic Obstructive Pulmonary Disease (COPD), a condition marked by exercise intolerance and skeletal muscle dysfunction, leading to fatigue, reduced daily activity, and higher fall risk especially in older adults. The study aims to evaluate the feasibility and effects of Maximal Strength Training (MST) compared to standard Endurance Training (ET) on strength, effort tolerance, fatigue, walking efficiency, breathlessness, and fall risk over a period of six months. Participants will undergo an 8-week outpatient rehabilitation program three times per week. One group will receive combined MST and ET, where MST involves four sets of five leg-press repetitions at 85-90% of their maximum strength focusing on quick force development, followed by a 40-minute cycling session at a patient-specific intensity. The other group will receive ET alone, consisting of 40-minute cycling sessions with progressive intensity and warm-up/cool-down periods. Both groups will maintain regular daily activities outside training days. Throughout the study, researchers will monitor changes in walking efficiency from baseline to 8 weeks and assess strength, effort tolerance, fatigue, dyspnea, and fall risk. Evaluations will include heart rate, blood pressure, oxygen levels, and perceived exertion during sessions. The goal is to understand how MST impacts physical performance and quality of life in COPD patients compared to standard endurance training, with follow-up assessments planned over six months.