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).
Diagnosis of COPD (Forced expiratory volume in 1 second / post-bronchodilator forced vital capacity < 0.7) without functional reversibility
Chronic respiratory failure with stable hypoxia (PaO2 < 60 mmHg in room air)
Long Term Oxygen Therapy (LTOT) for at least 3 months
Clinical 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 days
Non-invasive ventilation at home
Cognitive impairment (Mini-Mental State Examination Score < 22)
Asthma or evidence of bronchodilator response
Pulmonary fibrosis
Parallel
MS group
Other interventionAll 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
C group
Other interventionAll 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.
Change in effort tolerance at 6 minutes walking test: Minimal Clinical Important Difference (MCID) at 6MWT
To evaluate whether the training exercise with music, compared to usual training (without music), is more effective in improving the exercise capacity measured in terms of the number of patients able to achieve the MCID (Minimal Clinical Important Difference) of 30 meters at the six-minute walking test (6MWT).
Change in effort tolerance at 6 minutes walking test: distance at 6MWT
To evaluate whether the training exercise with music, compared to a usual training (without music), is more effective in improving the exercise capacity measured in terms of meters covered in six minutes
Change in effort tolerance at the constant load exercise test (CLET)
To evaluate whether the training exercise with music, compared to a usual training (without music), is more effective in improving the exercise capacity measured in terms of time measured in seconds at the CLET
Change in dyspnea: total sessions
To evaluate whether the training exercise with music, compared to a usual training (without music), is more effective in reducing dyspnoea (measured with the Borg scale) during training (total sessions)
Change in dyspnea:iso-times at CLET
To evaluate whether the training exercise with music, compared to a usual training (without music), is more effective in reducing dyspnea at the CLET by evaluating dyspnea at the same minutes observed in the initial test (iso-times)
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