Clinical trial NCT05832814: Music Therapy for COPD Rehabilitation
Official title: The Effect of Music Therapy in Pulmonary Rehabilitation of COPD Patients Aged 40-75
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
music therapy
pulmonary rehabilitation
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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:

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.

Primary outcomes:
measure: incremental shuttle walking test(ISWT) distance
timeFrame: 12 weeks
Secondary outcomes:
measure: Respiratory muscle strength
timeFrame: 12 weeks
measure: Spirometry
timeFrame: 12 weeks
measure: Short Physical Performance Battery(SPPB)
timeFrame: 12 weeks
measure: modified British medical research council(mMRC)
timeFrame: 12 weeks
measure: COPD assessment test(CAT)
timeFrame: 12 weeks
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: 12 weeks
measure: International Physical Activity Questionnaire Short Form (IPAQ-short)
timeFrame: 12 weeks
measure: Hospital Anxiety and Depression Scale(HADS)
timeFrame: 12 weeks
measure: Compliance
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Minghui Shi, MSc
role: STUDY_DIRECTOR
References: