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Found 7 Actively Recruiting clinical trials

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Actively Recruiting

Chronic Obstructive Pulmonary Disease COPD causes exercise intolerance and difficulty performing daily activities due to symptoms like breathlessness and fatigue. This research evaluates whether adding upper limb endurance training to the usual lower limb rehabilitation improves patients ability to perform daily tasks, compared to the standard lower limb training alone. The study is a randomized controlled trial aiming to improve exercise tolerance and quality of life in COPD patients. Participants will be assigned to one of two rehabilitation programs lasting 14 daily sessions of 90 minutes each. One group will perform lower limb training on a stationary bike plus strengthening exercises. The other group will combine lower limb cycling, arm ergometer training, and strengthening exercises for both upper and lower limbs. All sessions will be supervised by physiotherapists, and education about disease management will be provided. Throughout the study, participants will undergo clinical evaluations including lung function tests, blood gas analysis, and quality of life questionnaires. The main measurement is the time taken to complete the GLITTRE test, assessing daily living activities, evaluated from randomization to the end of the program up to 16 days. Secondary outcomes include changes in effort tolerance for upper and lower limbs and energy cost of walking. Safety and progress will be monitored during the rehabilitation period.

All GendersPhase Not Applicable
3 locations
S

Actively Recruiting

Researchers are investigating how adding a therapeutic dose of oxygen during exercise affects people with chronic respiratory failure or exertional hypoxemia due to chronic obstructive pulmonary disease COPD or interstitial lung disease. This multicenter crossover trial aims to evaluate exercise performance, gas exchange, heart rate, symptom perception, and ease of performing exercise in patients hospitalized in pulmonary rehabilitation centers. The study will compare walking ability during two conditions using the 6-minute walk test to understand the benefits of different oxygen levels during exertion. Participants will perform two 6-minute walk tests in random order within 24 hours. One test uses their usual oxygen flow prescribed at rest or room air for those with exertional hypoxemia, while the other uses double the prescribed oxygen flow or 2 liters per minute for patients with exertional hypoxemia. Oxygen is delivered through nasal cannulas with a stroller carrying the oxygen supply. Tests are separated by at least 3 hours. The study groups include patients with COPD with exertional hypoxemia, COPD with chronic respiratory failure on long-term oxygen therapy, and interstitial lung disease with chronic respiratory failure on long-term oxygen therapy. Participants will be assessed for walking distance, oxygen saturation, heart rate, blood pressure, and symptoms such as breathlessness and fatigue before, during, and after the tests. A questionnaire will capture how easy participants found the test. Researchers will analyze the difference in walking distance between conditions as the primary outcome. The study will also examine how clinical and anthropometric factors influence responses to oxygen therapy. The total planned enrollment is 114 patients, and the trial will provide insights for better oxygen therapy prescriptions during exercise.

Age: 18Years +All GendersPhase Not Applicable
6 locations
C

Actively Recruiting

Researchers are evaluating two types of early rehabilitation for people recovering from a COPD exacerbation, focusing on severe leg muscle weakness, especially in the quadriceps. The study compares a maximal strength training MST program using high loads and few repetitions to a traditional high-intensity endurance training program. The goal is to see which approach is easier to tolerate, especially regarding breathlessness, and which best improves muscle strength, efficiency, and overall exercise tolerance during recovery. Participants are randomly assigned to one of two training groups. The experimental group performs high-intensity resistance training HIRT with 4 sets of 5 repetitions at 90-95% of their maximum leg press strength, combined with low-intensity cycling at 20% of maximum workload. Sessions occur 5 times per week with a 2 days on, 1 day off cycle. The control group performs high-intensity endurance training HIET cycling at 70% of maximum workload for 25 minutes with progression based on symptoms, combined with low-intensity leg press strength training without progression. After 15 sessions, participants are evaluated and continue a combined training program until discharge. During the study, participants undergo assessments including walking tests, muscle strength measurements, ultrasound scans of muscles and diaphragm, quality of life questionnaires, and fatigue scales at enrollment, after 15 sessions, and at discharge. Researchers monitor heart rate, oxygen levels, symptoms, and side effects such as muscle soreness. The main outcome is reduction in breathlessness during daily activities. Secondary outcomes include functional capacity, fatigue, muscle strength, disease impact, walking efficiency, and satisfaction with training. The trial lasts up to about three weeks post-randomization, providing detailed monitoring throughout rehabilitation.

Age: 18Years +All GendersPhase Not Applicable
1 location
S

Actively Recruiting

Researchers are examining how different types of pain and autonomic symptoms affect people diagnosed with Parkinsons disease PD and multiple system atrophy MSA receiving care at Maugeri Clinical Scientific Institutes. The study aims to evaluate the prevalence and characteristics of pain and autonomic dysfunction, assess how rehabilitation impacts these symptoms, and understand their effect on quality of life for both inpatients and outpatients. All participants will receive a neurological exam and participate in a rehabilitation program designed to improve strength, coordination, balance, endurance, and daily living skills. Clinical scales will be used to assess disease stage, severity, motor and non-motor symptoms, cognitive function, depression, autonomic dysfunction, pain, and quality of life. The study compares patients with PD and MSA and measures outcomes before and after an average 30-day rehabilitation period. Participants will undergo evaluations at recruitment and after completing rehabilitation, including assessments of pain and autonomic symptoms. Researchers will monitor changes in clinical scores and quality of life throughout the study. This observational study will provide insights to help clinicians better manage disability and tailor rehabilitation strategies to improve patients well-being over the course of their care.

Age: 18Years +All Genders
9 locations
A

Actively Recruiting

Researchers are studying the effects of adding music to rehabilitation training for patients with Chronic Obstructive Pulmonary Disease COPD and chronic respiratory failure CRF. This trial compares usual rehabilitation training to training supported by music, aiming to see if music can improve exercise capacity, endurance, and reduce fatigue and breathlessness. Previous studies suggest music may help reduce symptoms like anxiety and dyspnea and improve quality of life for COPD patients during exercise. Participants will be randomly assigned to one of two groups a music-supported training group or a usual training group without music. The music group listens to selected music styles with a constant rhythm designed to synchronize with cycling exercise sessions lasting about 30 minutes. Both groups perform supervised training on a cycle ergometer, with the only difference being the presence or absence of music. Training occurs 5 to 6 times per week over 12 to 14 sessions. Throughout the study, participants will undergo various assessments including lung function tests, 6-minute walk tests, muscle strength measurements, blood gas analysis, and exercise endurance tests. Heart rate, oxygen saturation, and breathlessness levels will be monitored before and after each session. The primary outcome is the change in walking test performance after up to three weeks of training, with additional evaluations of breathlessness, fatigue, and disease impact on daily activities. Safety, adherence, and reasons for withdrawal will also be tracked by the study team.

Age: 40Years - 85YearsAll GendersPhase Not Applicable
6 locations
M

Actively Recruiting

This research focuses on patients with Chronic Obstructive Pulmonary Disease COPD who experience exercise intolerance and muscle weakness, leading to fatigue, reduced daily activity, and increased fall risk. The study aims to assess 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 six months. Participants will be randomly assigned to one of two groups for an 8-week outpatient rehabilitation program with sessions three times per week. One group will perform MST consisting of four sets of five repetitions on a leg press at 85-90% of their maximum load, focusing on rapid muscle contraction, followed by 40 minutes of cycling ET at a patient-specific intensity. The other group will perform ET alone, cycling for 40 minutes with intensity increasing based on symptoms. Both groups will maintain normal daily activities outside training days. Throughout the study, researchers will measure changes in walking efficiency, leg strength, rate of force development, effort tolerance, fatigue, muscle volume, breathlessness, inflammation markers, balance, quality of life, patient satisfaction, falls, hospitalizations, and mortality at baseline and after 8 weeks, with some measures followed until 8 months. Heart rate, blood pressure, oxygen levels, and symptoms will be monitored during sessions to ensure safety and track progress.

Age: 50Years - 80YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

This trial studies patients with atherosclerotic cardiovascular disease ASCVD, including those who have experienced acute or chronic coronary syndrome and ischemic heart failure. It focuses on those who have completed phase II cardiac rehabilitation CR and evaluates the effectiveness of a digitally-enhanced program during phase III CR compared to standard care. The study is a multicenter, prospective, controlled, randomized, open-label trial examining prevention strategies to support ongoing rehabilitation. Participants are randomized to either standard phase III care or standard care plus the Digitally-Enhanced Extended PrEvention & Rehabilitation DEEPER package. The DEEPER intervention includes informative digital modules chosen by the patient, delivered biweekly via a secure platform or booklet if offline, monthly motivational messages, a peer-support forum with leaderboards, and wearable device monitoring of steps and sleep. All participants receive a Fitbit smartwatch to encourage engagement and collect study data. During the study, participants will be monitored through digital communications and clinical visits, with assessments including the composite Lifes Essential 9 LE9 score at 6 months as the primary outcome. Other evaluations include mental health questionnaires, physical fitness tests, cardiovascular events, and social and economic impacts. Follow-up contacts include phone calls at 3 months and 1 year, with the total study duration extending up to one year after enrollment.

Age: 18Years +All GendersPhase Not Applicable
6 locations