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Studies

Interventional Recruiting

NCT05720780 on ClinicalTrials.gov

Rehabilitation Training With Music-support & Exercise Tolerance in COPD and CRF Patients.

Official title: 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
  • Enrollment: 156 (Estimated)
  • Study start: 2023-01-26 (Actual)
  • Primary completion: 2026-12-31 (Estimated)
  • Study completion: 2027-04-30 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Single (Outcomes Assessor)
  • PrimaryPurpose: Treatment

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).

Conditions

  • COPD

Intervention / Treatment

  • Other: MS group
  • Other: C group

Primary Outcome Measures

  • Change in effort tolerance at 6 minutes walking test: Minimal Clinical Important Difference (MCID) at 6MWT (From the date of randomization to the End of the program (up to 3 weeks))
    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).

Countries

Italy

Locations and Investigators

  • ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Telese, Telese Terme, Italy (Not yet recruiting)
  • ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane, Lumezzane, Italy (Recruiting)
    • Michele Vitacca, MD
    • Mara Paneroni, PhD, MSc, PT
  • ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Montescano, Montescano, Italy (Recruiting)
    • Rodolfo Murgia, MD
    • Giancarlo Piaggi, MSc, PT
  • ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Tradate, Tradate, Italy (Recruiting)
    • Antonio Spanevello, MD, Prof
    • Elisabetta Zampogna, MSc, PT
  • ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Bari, Bari, Italy (Not yet recruiting)
    • Maria Aliani, MD
  • ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Pavia, Pavia, Italy (Recruiting)
    • Piero Ceriana, MD
    • Alfredo Raglio

Study Officials

  • Michele Vitacca, MD (Study Director) — ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Lumezzane