Chronic Obstructive Pulmonary DiseaseCOPDMELODYNCT05832814
Music Therapy for COPD Rehabilitation
A study testing Integrated training and Rhythm-guided exercise training in people with Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Integrated training and Rhythm-guided exercise training
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 3 Feb 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with a clinical diagnosis of COPD and meeting the following criteria are eligible:
- Diagnosis of GOLD II-IV and without acute exacerbation within the last 4 weeks.
- Motivated for participating in the project (and acceptance of randomization)
- Sufficient mobility to attend PR
Who cannot join
- Certain comorbidities (e.g. unstable coronary complications)
- Severe cognitive disabilities (e.g. dementia)
- Inability to cope with the program because of severe hearing or visual disorder.
- No previous singing experience or musical competence is required.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship hospital
Beijing, Beijing Municipality
Minghui Shi, MSc, sunflower_justdoit@163.com
About this study
Official title: The Effect of Music Therapy in Pulmonary Rehabilitation of COPD Patients Aged 40-75
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Integrated training, Rhythm-guided exercise training
- Keywords
- COPD, music therapy, pulmonary rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated trainingBehavioural
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.
Rhythm-guided exercise trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Integrated training | Experimental | 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 Receives: Behavioral: Integrated training |
| Rhythm-guided exercise training | Experimental | 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 Receives: Behavioral: Rhythm-guided exercise training |
| Usual care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
incremental shuttle walking test(ISWT) distance
incremental shuttle walking test distance
Measured: 12 weeks
Secondary outcomes (9)
Respiratory muscle strength
maximum inspiratory pressure(MIP), maximum expiratory pressure(MEP)
Measured: 12 weeks
Spirometry
FEV1, FVC, FEV1/FVC, PEF, IC, RV, FRC, TLC
Measured: 12 weeks
Short Physical Performance Battery(SPPB)
Test for health-related physical performance
Measured: 12 weeks
modified British medical research council(mMRC)
It is a self-reported symptom questionnaire ranging from 0-4 score, higher scores mean a worse outcome.
Measured: 12 weeks
COPD assessment test(CAT)
It is a self-reported quality of life questionnaire ranging from 0-10 score, higher scores mean a worse outcome.
Measured: 12 weeks
St. George's Respiratory Questionnaire (SGRQ)
It is a self-reported symptom questionnaire ranging from 0-100 score, higher scores mean a worse outcome.
Measured: 12 weeks
International Physical Activity Questionnaire Short Form (IPAQ-short)
It is a questionnaire evaluating participants' quantity of physical activity in a recent week.
Measured: 12 weeks
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.
Measured: 12 weeks
Compliance
Self-produced sheet with registration each time of each participant's attendance or absence (with or without cause). Registered continuously during intervention period.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start3 Feb 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting YANG, China-Japan Friendship Hospital
- Investigators
- Minghui Shi, MSc, Study director, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832814
- Sponsor's protocol ID
- 2022-HX-16
- Acronym
- COPDMELODY
- Status last verified
- Oct 2023
- First submitted
- 31 Jul 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shi M, Yang L, Qumu S, Lei J, Huang K, He R, Niu H, Dong F, Wang S, He J, Yang T. Efficacy and safety of a music-therapy facilitated pulmonary telerehabilitation program in COPD patients: the COPDMELODY study protocol. Front Med (Lausanne). 2024 Mar 8;11:1361053. doi: 10.3389/fmed.2024.1361053. eCollection 2024.
PubMed 38523907
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Therapy in Pulmonary Rehabilitation of COPD Patients Aged 40-75
- ClinicalTrials.gov ID
- NCT05832814
- Acronym / sponsor ID
- COPDMELODY / 2022-HX-16
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, music therapy, pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Integrated training | Experimental | Behavioral: Integrated trainingRhythm-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 |
| Rhythm-guided exercise training | Experimental | Behavioral: Rhythm-guided exercise trainingRhythm-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 |
| Usual care | No intervention | –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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with a clinical diagnosis of COPD and meeting the following criteria are eligible:
- Diagnosis of GOLD II-IV and without acute exacerbation within the last 4 weeks.
- Motivated for participating in the project (and acceptance of randomization)
- Sufficient mobility to attend PR
Key exclusion criteria (4 listed)
- Certain comorbidities (e.g. unstable coronary complications)
- Severe cognitive disabilities (e.g. dementia)
- Inability to cope with the program because of severe hearing or visual disorder.
- No previous singing experience or musical competence is required.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated trainingFor 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. | Behavioural | Integrated training |
| Rhythm-guided exercise trainingFor 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. | Behavioural | Rhythm-guided exercise training |
Primary outcome
incremental shuttle walking test(ISWT) distance
Time frame: 12 weeks
incremental shuttle walking test distance
9 secondary outcomes
Respiratory muscle strength
Time frame: 12 weeks
Spirometry
Time frame: 12 weeks
Short Physical Performance Battery(SPPB)
Time frame: 12 weeks
modified British medical research council(mMRC)
Time frame: 12 weeks
COPD assessment test(CAT)
Time frame: 12 weeks
St. George's Respiratory Questionnaire (SGRQ)
Time frame: 12 weeks
International Physical Activity Questionnaire Short Form (IPAQ-short)
Time frame: 12 weeks
Hospital Anxiety and Depression Scale(HADS)
Time frame: 12 weeks
Compliance
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Derived from this study: PubMed 38523907Shi M, Yang L, Qumu S, Lei J, Huang K, He R, Niu H, Dong F, Wang S, He J, Yang T. Efficacy and safety of a music-therapy facilitated pulmonary telerehabilitation program in COPD patients: the COPDMELODY study protocol. Front Med (Lausanne). 2024 Mar 8;11:1361053. doi: 10.3389/fmed.2024.1361053. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minghui Shi, MSc study director
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated training and Rhythm-guided exercise training in people with Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting Yang, MD (84206272, zryyyangting@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incremental shuttle walking test(ISWT) distance (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05832814, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.