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NCT05720780
Rehabilitation Training With Music-support & Exercise Tolerance in COPD and CRF Patients. A Randomized Controlled Trial
Conditions: COPD
Sex: All
Ages: 40 Years – 85 Years
Phase: NA
Enrollment: 156
Sponsor: Istituti Clinici Scientifici Maugeri SpA
Location: Italy
Summary
Therapeutic-rehabilitative interventions supported by music can be considered important resources in many clinical contexts.
Some studies report the improvement of psychological (i.e.
anxiety) and physiological parameters such for example, dyspnea, blood pressure, quality of life, sleep disturbances, etc. through voice, singing, exercise with wind instruments, and sometimes listening to music.
Among the various instruments proposed to support the physical training of COPD patients, music was also tested and, in particular, music as a distracting auditory stimulus (DAS) has been used to increase exercise and physical activity adherence and to reduce the perception of dyspnea in COPD subjects.This randomized controlled trial will compare -in patients with COPD and CRF- the effects of the addiction of music to the training on exercise capacity (possible improvement of endurance and reduction of fatigue and dyspnea) with respect to the usual rehabilitation modality (no music).
Eligibility Criteria
Inclusion Criteria:Diagnosis of COPD (Forced expiratory volume in 1 second / post-bronchodilator forced vital capacity < 0.7) without functional reversibilityChronic respiratory failure with stable hypoxia (PaO2 < 60 mmHg in room air)Long Term Oxygen Therapy (LTOT) for at least 3 monthsClinical stability: pH range 7.38-7.42,
with no recent exacerbations in the last 7 days and no changes in drug therapy in the previous 7 daysExclusion Criteria:Non-invasive ventilation at homeCognitive impairment (Mini-Mental State Examination Score < 22)Asthma or evidence of bronchodilator responsePulmonary fibrosisObstructive sleep apnea syndromeLung cancerActive microbial infectionsNeuromuscular, orthopedic, and/or medical conditions that preclude testingPulmonary rehabilitation program in the previous 6 months
Source: ClinicalTrials.gov (NCT05720780). StuddyBuddy aggregates publicly available trial information.