Clinical trial NCT05995847: Effectiveness of Harmonica Playing in Improving Lung Function Among COPD Patients
Official title: The Effectiveness of Harmonica Playing in Improving Lung Function Among In-home Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in FEV1 % predicted
timeFrame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Secondary outcomes:
measure: Change in individual strength
timeFrame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
measure: Change in fatigue
timeFrame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
measure: Compliance and satisfaction
timeFrame: After 6 months of intervention
measure: Change in self-efficacy
timeFrame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
measure: Change in psychological well-being
timeFrame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
measure: Change in quality of life
timeFrame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
measure: Change in symptoms
timeFrame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
measure: Change in level of physical activity
timeFrame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
measure: Changes in levels of breathlessness
timeFrame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
measure: Changes in clinical control
timeFrame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
measure: Social support status
timeFrame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
measure: Change in inspiratory muscle strength
timeFrame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
measure: Change in expiratory muscle strength
timeFrame: At baseline, after 1 month, after 3 months, and after 6 months of intervention
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The first affiliated hospital of Guangzhou Medical Univeristy
Study officials:
References: