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

NCT05720780 | Recruiting

• 1 other identifier: ICS Maugeri 2712 CE
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 6

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

Keywords

distracting auditory stimulus (DAS); COPD; CRF; music therapy; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in effort tolerance at 6 minutes walking test: Minimal Clinical Important Difference (MCID) at 6MWT

  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).

  From the date of randomization to the End of the program (up to 3 weeks)

Secondary Outcomes (7)

• Change in effort tolerance at 6 minutes walking test: distance at 6MWT

  From the date of randomization to the End of the program (up to 3 weeks)

• Change in effort tolerance at the constant load exercise test (CLET)

  From the date of randomization to the End of the program (up to 3 weeks)

• Change in dyspnea: total sessions

  From the date of randomization to the End of the program (up to 3 weeks)

• Change in dyspnea:iso-times at CLET

  From the date of randomization to the End of the program (up to 3 weeks)

• Change in dyspnea during daily life activities (ADL) by Medical Research Council (MRC)

  From the date of randomization to the End of the program (up to 3 weeks)

Study Arms (2)

Usual training with the support of music (MS)

EXPERIMENTAL

This is the group performing training with the support of the music; it will be the intervention study group (MS)

Other: MS group

Usual training without music (C)

ACTIVE COMPARATOR

This is the usual training group without the support of the music, it will be the control group (C)

Other: C group

Interventions

MS group OTHER

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

Also known as: Experimental

Usual training with the support of music (MS)

C group OTHER

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.

Also known as: Active Comparatore

Usual training without music (C)

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (6)

ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Telese

Telese Terme, Benevento, 82037, Italy

NOT YET RECRUITING

ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane

Lumezzane, Brescia, 25065, Italy

RECRUITING

ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Montescano

Montescano, Pavia, 27040, Italy

RECRUITING

ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Tradate

Tradate, Varese, 21049, Italy

RECRUITING

ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Bari

Bari, 70100, Italy

NOT YET RECRUITING

ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Pavia

Pavia, 27100, Italy

RECRUITING

Related Publications (15)

• Lee AL, Desveaux L, Goldstein RS, Brooks D. Distractive Auditory Stimuli in the Form of Music in Individuals With COPD: A Systematic Review. Chest. 2015 Aug;148(2):417-429. doi: 10.1378/chest.14-2168.

  PMID: 25741661 BACKGROUND

• Braun Janzen T, Koshimori Y, Richard NM, Thaut MH. Rhythm and Music-Based Interventions in Motor Rehabilitation: Current Evidence and Future Perspectives. Front Hum Neurosci. 2022 Jan 17;15:789467. doi: 10.3389/fnhum.2021.789467. eCollection 2021.

  PMID: 35111007 BACKGROUND

• Canga B, Azoulay R, Raskin J, Loewy J. AIR: Advances in Respiration - Music therapy in the treatment of chronic pulmonary disease. Respir Med. 2015 Dec;109(12):1532-9. doi: 10.1016/j.rmed.2015.10.001. Epub 2015 Oct 19.

  PMID: 26522499 BACKGROUND

• Ho CF, Maa SH, Shyu YI, Lai YT, Hung TC, Chen HC. Effectiveness of paced walking to music at home for patients with COPD. COPD. 2012 Aug;9(5):447-57. doi: 10.3109/15412555.2012.685664. Epub 2012 May 29.

  PMID: 22643033 BACKGROUND

• Huang J, Yuan X, Zhang N, Qiu H, Chen X. Music Therapy in Adults With COPD. Respir Care. 2021 Mar;66(3):501-509. doi: 10.4187/respcare.07489. Epub 2020 Nov 3.

  PMID: 33144384 BACKGROUND

• Kaasgaard M, Rasmussen DB, Andreasson KH, Hilberg O, Lokke A, Vuust P, Bodtger U. Use of Singing for Lung Health as an alternative training modality within pulmonary rehabilitation for COPD: a randomised controlled trial. Eur Respir J. 2022 May 19;59(5):2101142. doi: 10.1183/13993003.01142-2021. Print 2022 May.

  PMID: 34625480 BACKGROUND

• Shingai K, Kanezaki M, Senjyu H. Distractive Auditory Stimuli Alleviate the Perception of Dyspnea Induced by Low-Intensity Exercise in Elderly Subjects With COPD. Respir Care. 2015 May;60(5):689-94. doi: 10.4187/respcare.03533. Epub 2015 Jan 13.

  PMID: 25587171 BACKGROUND

• Lee AL, Dolmage TE, Rhim M, Goldstein RS, Brooks D. The Impact of Listening to Music During a High-Intensity Exercise Endurance Test in People With COPD. Chest. 2018 May;153(5):1134-1141. doi: 10.1016/j.chest.2017.12.001. Epub 2017 Dec 16.

  PMID: 29253555 BACKGROUND

• Okamoto J, Furukawa Y, Kobinata N, Yoshikawa H, Araki F, Yagyu A, Iwasaka Y. Combined effect of pulmonary rehabilitation and music therapy in patients with chronic obstructive pulmonary disease. J Phys Ther Sci. 2021 Oct;33(10):779-783. doi: 10.1589/jpts.33.779. Epub 2021 Oct 13.

  PMID: 34658524 BACKGROUND

• Panigrahi A, Sohani S, Amadi C, Joshi A. Role of music in the management of chronic obstructive pulmonary disease (COPD): a literature review. Technol Health Care. 2014;22(1):53-61. doi: 10.3233/THC-130773.

  PMID: 24398814 BACKGROUND

• Raglio A, Oasi O. Music and health: what interventions for what results? Front Psychol. 2015 Mar 2;6:230. doi: 10.3389/fpsyg.2015.00230. eCollection 2015. No abstract available.

  PMID: 25784891 BACKGROUND

• Raglio A. Music and neurorehabilitation: Yes, we can! Funct Neurol. 2018 Oct/Dec;33(4):173-174. No abstract available.

  PMID: 30663962 BACKGROUND

• Vitacca M, Paneroni M, Zampogna E, Visca D, Carlucci A, Cirio S, Banfi P, Pappacoda G, Trianni L, Brogneri A, Belli S, Paracchini E, Aliani M, Spinelli V, Gigliotti F, Lanini B, Lazzeri M, Clini EM, Malovini A, Ambrosino N; Associazione Italiana Riabilitatori Insufficienza Respiratoria and Associazione Italiana Pneumologi Ospedalieri rehabilitation group. High-Flow Oxygen Therapy During Exercise Training in Patients With Chronic Obstructive Pulmonary Disease and Chronic Hypoxemia: A Multicenter Randomized Controlled Trial. Phys Ther. 2020 Aug 12;100(8):1249-1259. doi: 10.1093/ptj/pzaa076.

  PMID: 32329780 BACKGROUND

• Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.

  PMID: 25359355 BACKGROUND

• Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.

  PMID: 19720809 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michele Vitacca, MD

  ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Lumezzane

  STUDY DIRECTOR

Central Study Contacts

Michele Vitacca, MD

CONTACT

0039+030+8253; michele.vitacca@icsmaugeri.it

Tiziana Bachetti, Pharm

CONTACT

+0039+0382+593; tiziana.bachetti@icsmaugeri.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: January 26, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

IT (6)