Rehabilitation training using music for COPD and chronic respiratory failure 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.
This study tests if adding music to rehabilitation training can help people with COPD and chronic respiratory failure exercise better and feel less short of breath.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Locations | 6 sites (Telese Terme, Benevento and 5 other locations) |
| Trial ID | NCT05720780 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of incorporating music as a distracting auditory stimulus during rehabilitation training for patients with Chronic Obstructive Pulmonary Disease (COPD) and chronic respiratory failure (CRF). The study aims to compare exercise capacity, endurance, and perception of dyspnea between a group receiving music-supported training and a control group undergoing standard rehabilitation without music. By utilizing music therapy techniques, the trial seeks to enhance the psychological and physiological outcomes of rehabilitation. Participants will be monitored for improvements in exercise tolerance and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with COPD and chronic respiratory failure who are clinically stable and have been on long-term oxygen therapy.
Not a fit: Patients with cognitive impairments, active infections, or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve exercise capacity and quality of life for patients with COPD and CRF.
How similar studies have performed: Previous studies have shown promising results with music therapy in rehabilitation contexts, suggesting potential for success in this novel application for COPD patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Telese Terme, Benevento and 5 other locations
- ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Telese — Telese Terme, Benevento, Italy (Not_yet_recruiting)
- ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane — Lumezzane, Brescia, Italy (Recruiting)
- ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Montescano — Montescano, Pavia, Italy (Recruiting)
- ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Tradate — Tradate, Varese, Italy (Recruiting)
- ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Bari — Bari, Italy (Not_yet_recruiting)
- ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Pavia — Pavia, Italy (Recruiting)
Study contacts
- Study coordinator: Michele Vitacca, MD
- Email: michele.vitacca@icsmaugeri.it
- Phone: 0039+030+8253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.