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

Inclusion Criteria4

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

Exclusion Criteria9

Non-invasive ventilation at home
Cognitive impairment (Mini-Mental State Examination Score \< 22)
Asthma or evidence of bronchodilator response
Pulmonary fibrosis
Obstructive sleep apnea syndrome
Lung cancer
Active microbial infections
Neuromuscular, orthopedic, and/or medical conditions that preclude testing
Pulmonary rehabilitation program in the previous 6 months

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.