RecruitingNot ApplicableNCT05720780

Rehabilitation Training With Music-support & Exercise Tolerance in COPD and CRF Patients.

Can Rehabilitation Training With Music-support Increase Exercise Tolerance in Individuals With COPD and CRF Compared to Rehabilitation Training Alone? A Randomized Control Trial.

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Enrollment

156 participants

Start Date

Jan 26, 2023

Study Type

INTERVENTIONAL

Conditions

COPD

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

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding music to a pulmonary rehabilitation exercise program helps patients with severe COPD (chronic obstructive pulmonary disease) and chronic respiratory failure exercise longer and more comfortably, and whether this translates into better breathing outcomes. **You may be eligible if...** - You have a confirmed diagnosis of COPD with severe breathing limitation (FEV1/FVC ratio below 0.7) - You have chronic respiratory failure with low blood oxygen levels (PaO2 below 60 mmHg on room air) - You have been on long-term home oxygen therapy for at least 3 months - Your condition has been clinically stable with no recent flare-ups **You may NOT be eligible if...** - You use non-invasive ventilation at home (e.g., BiPAP or CPAP) - You have significant cognitive impairment - You have asthma, pulmonary fibrosis, sleep apnea, or lung cancer - You have had pulmonary rehabilitation in the past 6 months - You have a neuromuscular or orthopedic condition that prevents exercise Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERMS group

All patients will perform the usual training by listening a piece of music of the same duration as the training. The patient will be able to choose among 4 different musical proposals corresponding to 4 different styles: rock, modern, jazz and classical. The song chosen by the patient will be the musical support for all the sessions of training on the cycle ergometer. The musical pieces will be composed with a constant rhythm (bpm=60) which, from a tonal point of view, will echo the pedaling movement. The constant rhythm will be superimposed on musical patterns in the form of loops in the styles mentioned. The musical support will assume a "priming" (activation) and "dragging" (synchronization) function, facilitating movement planning/synchronization and creating a pleasant context in which to carry out training

OTHERC group

All patients will perform 12 to 14 supervised sessions depending on the center they belong to (5-6 sessions/week) each consisting of 30 minutes of exercise at the cycle ergometer plus 3 minutes of warm-up and 3 minutes of recovery. After a warm-up phase at 0 W, the initial workload will be set to 60% of the theoretical maximum. Intensity increases or decreases of 10 W will be made according to the criteria of Maltais et al (workload will be increased when patients will report dyspnea and/or leg fatigue as ≤3 on a Borg scale modified to 10 points of perceived effort. The training load will remain unchanged if the Borg score is 4 or 5 and will be reduced for scores ≥6). Patients will have to maintain a pedaling frequency between 55 and 60 rpm.