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.