Rehabilitation Training With Music-support & Exercise Tolerance in COPD and CRF Patients.
Recruiting · NCT05720780 · Interventional (participants receive a specific treatment) · Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
6 locations listed.
- ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Bari - Bari, Italy
- ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Pavia - Pavia, Italy
- ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Telese - Telese Terme, Benevento, Italy
- ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane - Lumezzane, Brescia, Italy
- ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Montescano - Montescano, Pavia, Italy
- ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Tradate - Tradate, Varese, Italy