NCT05720780 Rehabilitation Training With Music-support & Exercise Tolerance in COPD and CRF Patients.
| NCT ID | NCT05720780 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA |
| Condition | COPD |
| Study Type | INTERVENTIONAL |
| Enrollment | 156 participants |
| Start Date | 2023-01-26 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 156 participants in total. It began in 2023-01-26 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Michele Vitacca, MD
STUDY DIRECTOR
ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Lumezzane
Frequently Asked Questions
Who can join the NCT05720780 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 85 Years, studying COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05720780 currently recruiting?
Yes, NCT05720780 is actively recruiting participants. Contact the research team at michele.vitacca@icsmaugeri.it for enrollment information.
Where is the NCT05720780 trial being conducted?
This trial is being conducted at Telese Terme, Italy, Lumezzane, Italy, Montescano, Italy, Tradate, Italy and 2 additional locations.
Who is sponsoring the NCT05720780 clinical trial?
NCT05720780 is sponsored by Istituti Clinici Scientifici Maugeri SpA. The principal investigator is Michele Vitacca, MD at ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Lumezzane. The trial plans to enroll 156 participants.
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