Effectiveness of Harmonica Playing in Improving Lung Function Among COPD Patients

Guangzhou Medical University

Status: Enrolling

Conditions: COPD

Treatments: Behavioral: Harmonica playing program plus basic PR care with routine follow-up; Behavioral: Basic PR care with routine follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT05995847

ZQiuxuan

Details and patient eligibility

About

Although it has been documented that harmonica playing plays a role in the pulmonary rehabilitation (PR) of patients with chronic obstructive pulmonary disease (COPD), current studies are limited by small sample sizes, uncomprehensive outcome indicators, and short intervention durations. Thus, the investigators aim to compare the harmonica combination group with the basic-PR-care group in terms of improving health outcomes among COPD patients, such as lung function, self-efficacy, quality of life, compliance with training, and emotional distress.

Full description

Chronic Obstructive Pulmonary Disease (COPD) is an avoidable and treatable condition characterized by chronic respiratory symptoms and airflow obstruction, primarily due to airway and/or alveolar abnormalities from toxic elements. Because of COPD's high prevalence and mortality, its prevention and treatment pose a global public health challenge that needs addressing.

Pulmonary rehabilitation (PR) is considered a cornerstone of COPD management because it effectively improves exercise tolerance, exercise-induced dyspnea, fatigue, and health-related quality of life. Inspiratory muscle training (IMT) plays an important role in PR. Studies suggest that harmonica playing can emulate inspiratory muscle training, enhancing pulmonary function in COPD patients. Additionally, as a music therapy approach, harmonica playing may alleviate the emotional distress often seen in these individuals.

However, existing studies haven't provided robust evidence to support harmonica playing's efficacy in enhancing COPD patients' health outcomes due to limitations like small sample sizes, non-trial study designs, incomplete outcomes, and short intervention durations. It remains unclear whether harmonica playing can improve COPD patients' physiological and psychological health outcomes.

This study's primary aim is to evaluate whether harmonica playing can boost the lung function of COPD patients compared to those only receiving basic PR care in the control group. The secondary aim is to investigate if harmonica playing can enhance other outcomes related to physical and psychological aspects, such as self-efficacy, quality of life, training compliance, and emotional distress.

Methods:

This is a single-center RCT with a low-risk intervention.

Patients who meet the inclusion criteria and do not meet any exclusion criteria will be randomly assigned to either the intervention or control group. The intervention group will receive a harmonica playing program in addition to basic PR care, excluding the pursed-lip breathing exercise, along with routine follow-up. In contrast, the control group will receive basic PR care, which includes the pursed-lip breathing exercise, along with routine follow-up.

Details of the treatments in both groups are provided in the intervention section.

At baseline and six months post-intervention, the investigators will collect clinical evaluations including:

Lung function (Pulmonary function laboratory tests will be performed only at baseline and six months post-intervention) Physical activity Symptoms Quality of life Psychological well-being (focusing on depression and anxiety) Self-efficacy Fatigue Self-reported compliance and satisfaction Outcome measures will be detailed in the subsequent section.

FEV1% predicted is a commonly used outcome indicator in PR and is suitable for sample size estimation. According to results from similar studies, the minimum clinically important difference (MCID) for FEV1% predicted is 4%, with a baseline standard deviation (SD) of 10%. Given a two-tailed significance level of 0.05 and a power of 80%, each group requires a minimum of 99 participants. Accounting for a drop-out rate of 20%, an estimated 248 patients (124 per group) will be enrolled.

Statistical evaluation will be performed using the SPSS 21.0 program. The intention-to-treat (ITT) approach will be adopted for data analysis.

Enrollment: 248 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

● Clinical diagnosis of COPD.

Exclusion criteria

• Individuals with a history of COPD exacerbation within the last 6 weeks. An exacerbation is defined as a deterioration in at least two respiratory symptoms that necessitate hospitalization.
• Individuals with comorbidities that affect physical activity, such as severe cardiac or neurological disorders, cancer, or musculoskeletal problems.
• Individuals with cognitive disorders.
• Individuals unable to speak or understand spoken/written Chinese.
• Individuals who have participated in pulmonary rehabilitation (or any other structured, disease-related physical training) within the previous 6 months.
• Individuals who have played the harmonica, or other similar instrument, regularly in the previous 6 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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248 participants in 2 patient groups

harmonica combination group

Experimental group

Description:

These patients will participate in a six-month harmonica playing program, in addition to receiving basic pulmonary rehabilitation (PR) care, which includes self-management education, exercise training, and breathing training, as well as routine follow-up. All training sessions are home-based and will take place five days per week for six months.

Treatment:

Behavioral: Harmonica playing program plus basic PR care with routine follow-up

basic-PR-care group

Active Comparator group

Description:

These patients will receive basic pulmonary rehabilitation (PR) care, which includes self-management education, exercise training, and breathing training, as well as routine follow-up. All training sessions are home-based and will take place five days per week for six months.

Treatment:

Behavioral: Basic PR care with routine follow-up