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RecruitingNCT05832814COPDMELODYUpdated Oct 10, 2023

Music Therapy for COPD Rehabilitation

An interventional study of Integrated training and Rhythm-guided exercise training in Chronic Obstructive Pulmonary Disease, sponsored by China-Japan Friendship Hospital. Recruiting at 1 site in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by China-Japan Friendship Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started Feb 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study summary

Chronic obstructive pulmonary disease(COPD) patients could benefit from pulmonary rehabilitation(PR) in better managing of the disease and its symptoms and in avoiding future relapses and hospitalizations. However, due to a large number of drop outs from PR, lack of professionals, and the COVID-19 epidemic, the PR has been underutilized, leading to a need for investigation of updated forms. Music therapy, such as rhythm-guided endurance training, singing training, listening to melody, may be one such potential relevant and motivating rehabilitation activity. The study aims to investigate the effects of home-based PR program with a rhythm-guided endurance walking exercise and singing training on both physiological and psychological aspects. Effects will be investigated in a randomized controlled trial (RCT) with 12-week intervention period.

Read the detailed description

Physiology and psychology of COPD

COPD is a syndrome with a progressive pulmonary obstruction leading to increasingly impaired lung function due to chronic inflammation in the respiratory passages and pulmonary tissue. Living with COPD everyday life is a struggle and often marked with reduced physical activity, again leading to progression of disease, by which a vicious circle develops. Declining physical performance is associated with ventilation restriction, insufficient oxygen diffusion, respiratory muscle and peripheral skeletal muscle dysfunction, ventricular dysfunction and so on.

On a psychological level COPD patients tend to suffer from comorbidities such as increased stress and anxiety levels e.g. due to dyspnea and dysfunction. In conclusion, COPD often leads to a severe condition that both physically and psychologically can be very difficult to manage and cope with.

COPD and rehabilitation

Pulmonary rehabilitation (PR) is multidisciplinary and comprehensive intervention that may improve the interrelated physical and psychological consequences of the disease. It is designed to optimize functional status, reduce symptoms, improve health-related quality of life, reduce anxiety and depression, reduce exacerbations and mortality. However, in spite of documented efficacy and strong recommendations, PR is largely underutilized because most programs have been carried out on an inpatient or outpatient basis, relying on high cost, adequate doctors or therapists and regular visits to hospital. Another problem is the long-term maintenance of benefits once the hospital-based PR program has been completed, since gains achieved diminish progressively if training is abandoned. For these reasons, home-based PR has been proposed as an alternative to outpatient rehabilitation.

Just like the supervised training, a home-based PR program must include endurance exercise training, e.g. walking. Optimally, a program should also include respiratory muscle training.

Reviewing previous relevant researches, the current common home-based PR models have several limitations. The compliance is still pretty poor, both due to fear of dyspnea and fragility during training and tiring of inflexible exercise form. There is also a concern about ensurance of the exercise intensity during a home-based PR. Therefore it is of high importance to develop alternative rehabilitation activities that are motivating and are perceived helpful for the participants. This study aims to investigate music therapy(MT) as a new complementary therapy, since MT has the potential to facilitate exercise training and strengthen motivation of rehabilitation activity, with both physiological and psychological effects.

Music therapy and COPD rehabilitation

A number of international studies have investigated the effects of MT in relation to COPD patients. Music therapy targeting at COPD patients include offering music during exercise(distractive auditory stimulus therapy) and singing training. Compared with traditional aerobic exercise, rhythm-guided endurance training has the potential to help patients achieve a higher workload through decreasing or delaying the perception of exercise-induced dyspnea and fatigue. In terms of singing training, it could help patients learn how to control the respiratory function, including training and coordination of the related inspiratory and expiratory musculature. Moreover, from a psychology perspective, music in general seems to have an ability to promote motivations, and have a positive impact on well-being, anxiety and depression level.

Previous studies differ in methodology, and furthermore sample size and statistical power are not sufficient to conclude on significance and results. Most relevant researches are carried out in hospital or community-based face-to-face monitoring classes. No study has explored the integrated effects of music-facilitated exercise and singing training, although they might benefit COPD patients further through different physiological mechanisms compared with being applied separately. Therefore the present study is of high prevalence. Since it aims to develop alternative, motivating and personalized solutions to supplement standard PR, exploring whether singing training combined with melody-guided endurance exercise confers further benefits in exercise capacity and how music therapy influences patients' exercise performance, respiratory muscle strength, dyspnea, spirometry, quality of life and emotions.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • COPD
  • music therapy
  • pulmonary rehabilitation
03

In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's planned enrollment of 75 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

China-Japan Friendship Hospital is the lead sponsor of 173 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Participants with a clinical diagnosis of COPD and meeting the following criteria are eligible:

  1. Diagnosis of GOLD II-IV and without acute exacerbation within the last 4 weeks.
  2. Motivated for participating in the project (and acceptance of randomization)
  3. Sufficient mobility to attend PR

Exclusion criteria

Exclusion Criteria:

  1. Certain comorbidities (e.g. unstable coronary complications)
  2. Severe cognitive disabilities (e.g. dementia)
  3. Inability to cope with the program because of severe hearing or visual disorder.

No previous singing experience or musical competence is required.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    Integrated training

    Rhythm-guided walking exercise coordinated with singing training as training activity in pulmonary rehabilitation: 12 weeks, three times a week for 1 hour, leading to a total of 36 sessions

    Behavioral: Integrated training

  • Experimental
    Rhythm-guided exercise training

    Rhythm-guided walking exercise as training activity in pulmonary rehabilitation: 12 weeks, three times a week for 1/2 hour, leading to a total of 36 sessions

    Behavioral: Rhythm-guided exercise training

  • No intervention
    Usual care

    The usual care is the comparator in the trial, consisting of standard medical treatment and educational sessions including physical training, smoking cessation and vaccination. And after the trial, the patients in this group will also be offered standard pulmonary rehabilitation according to the national guideline.

Interventions

  • BehavioralIntegrated training

    For rhythm-guided walking exercise, the home exercise intensity, that is, the walking speed can be prescribed based on the incremental shuttle walking(ISWT) result. A rhythm matching with the walking speed can be calculated. Then patients will be provided a group of melodies identified by the calculated rhythm, which are also popular with the elder. During exercise, the patients are required to walking on a fixed speed identical with the rhythm. For singing training, patients follow the audios and videos to take training at home, which are recorded by singing teachers and physiotherapists prior to the trial. Each session includes technical instructions in order to achieve better respiratory control during singing.

  • BehavioralRhythm-guided exercise training

    For rhythm-guided walking exercise, the home exercise intensity, that is, the walking speed can be prescribed based on the incremental shuttle walking test(ISWT) result. A rhythm matching with the walking speed can be calculated. Then patients will be provided a group of melodies identified by the calculated rhythm, which are also popular with the elder. During exercise, the patients are required to walking on a fixed speed identical with the rhythm.

06

What researchers measure

Primary outcomes

  1. incremental shuttle walking test(ISWT) distance

    incremental shuttle walking test distance

    Time frame: 12 weeks

Secondary outcomes

  1. Respiratory muscle strength

    maximum inspiratory pressure(MIP), maximum expiratory pressure(MEP)

    Time frame: 12 weeks

  2. Spirometry

    FEV1, FVC, FEV1/FVC, PEF, IC, RV, FRC, TLC

    Time frame: 12 weeks

  3. Short Physical Performance Battery(SPPB)

    Test for health-related physical performance

    Time frame: 12 weeks

  4. modified British medical research council(mMRC)

    It is a self-reported symptom questionnaire ranging from 0-4 score, higher scores mean a worse outcome.

    Time frame: 12 weeks

  5. COPD assessment test(CAT)

    It is a self-reported quality of life questionnaire ranging from 0-10 score, higher scores mean a worse outcome.

    Time frame: 12 weeks

  6. St. George's Respiratory Questionnaire (SGRQ)

    It is a self-reported symptom questionnaire ranging from 0-100 score, higher scores mean a worse outcome.

    Time frame: 12 weeks

  7. International Physical Activity Questionnaire Short Form (IPAQ-short)

    It is a questionnaire evaluating participants' quantity of physical activity in a recent week.

    Time frame: 12 weeks

  8. Hospital Anxiety and Depression Scale(HADS)

    It is a self-reported psychological status questionnaire ranging from 0-42 score, higher scores mean a worse outcome.

    Time frame: 12 weeks

  9. Compliance

    Self-produced sheet with registration each time of each participant's attendance or absence (with or without cause). Registered continuously during intervention period.

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05832814
Lead sponsor
China-Japan Friendship Hospital
Responsible party
Ting YANG (Principal Investigator, Clinical Professor, China-Japan Friendship Hospital) — Principal investigator
First posted
Apr 27, 2023
Start date
Feb 3, 2023
Primary completion
Dec 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Oct 10, 2023

Study contacts

Ting Yang, MD
Contact
zryyyangting@163.com
84206272
Minghui Shi, MSc
study director · China-Japan Friendship Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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