Effectiveness of Harmonica Playing in Improving Lung Function Among COPD Patients

COPD Clinical Trial

Official title:

The Effectiveness of Harmonica Playing in Improving Lung Function Among In-home Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05995847
• Other study ID #: ZQiuxuan
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2023
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Qiuxuan Zeng, Bachelor
• Phone: +86 15975789501
• Email: zengqiuxuan[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD

Intervention

Behavioral:
• Harmonica playing program plus basic PR care with routine follow-up
The intervention will last for a total of six months. During this period, patients are expected to play the harmonica daily for 30 minutes, five days a week. Additionally, 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 the duration of six months.
• Basic PR care with routine follow-up
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 the duration of six months

Locations

Country	Name	City	State
China	The first affiliated hospital of Guangzhou Medical Univeristy	Guangzhou
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in FEV1 % predicted	The investigators will assess patients' lung function using a lung function detector to obtain the outcome of FEV1 % predicted.	At baseline, after 1 month, after 3 months, and after 6 months of intervention
Secondary	Change in individual strength	The CIS-Fatigue Scale will be used to assess the level of individual fatigue. The total score for the CIS-Fatigue can range from 7 to 56. A higher score indicates a lower level of individual strength.	At baseline, after 1 month, after 3 months, and after 6 months of intervention
Secondary	Change in fatigue	The FACIT-F scale will be used to assess changes in fatigue. The total score for the FACIT-F scale can range from 0 to 52. A higher score indicates a higher level of fatigue.	At baseline, after 1 month, after 3 months, and after 6 months of intervention
Secondary	Compliance and satisfaction	A self-designed questionnaire will be utilized, which contains questions about participants' compliance and satisfaction.	After 6 months of intervention
Secondary	Change in self-efficacy	The Chinese version of the COPD Self-Efficacy Scale for Chronic (CSES) will be employed to evaluate patients' disease self-efficacy. This is a 31-item scale, with responses ranging from 1 (not confident at all) to 5 (very confident). Responses are summed to produce a total score for each participant. Scores can range from 31 to 155, with higher scores indicating greater self-efficacy.	At baseline, after 1 month, after 3 months, and after 6 months of intervention
Secondary	Change in psychological well-being	The Hospital Anxiety and Depression Scale (HADS) will be used to assess patients' anxiety and depression. Higher scores indicate increased levels of anxiety or depression. Subscale scores of =11 are considered indicative of a 'definite case'. Scores of 8 to 10 suggest a 'suspicious case', and scores of 0 to 7 are deemed a 'noncase' for anxiety or depression.	At baseline, after 1 month, after 3 months, and after 6 months of intervention
Secondary	Change in quality of life	The St. George's Respiratory Questionnaire (SGRQ) will be used to assess patients' quality of life. The total score ranges from 0 to 100. A score of 0 indicates no impairment in quality of life, while a score of 100 denotes maximum impairment. A higher score indicates a poorer quality of life.	At baseline, after 1 month, after 3 months, and after 6 months of intervention
Secondary	Change in symptoms	The COPD Assessment Test (CAT) will be employed to assess participants' symptom changes. The total score can range from 0 to 40. A higher score on the CAT indicates a more severe impact of COPD on a patient's health status and thus worse outcomes.	At baseline, after 1 month, after 3 months, and after 6 months of intervention
Secondary	Change in level of physical activity	The 6-minute walk distance, which represents the level of physical activity, will be assessed using a 6-minute walk test. A shorter 6MWD typically indicates poorer exercise tolerance and correlates with more severe disease.	At baseline, after 1 month, after 3 months, and after 6 months of intervention
Secondary	Changes in levels of breathlessness	The Modified Medical Research Council (mMRC) Dyspnea Scale will be used to gauge participants' level of breathlessness. Scores range from 0 to 4, with a higher score signifying more severe breathlessness.	At baseline, after 1 month, after 3 months, and after 6 months of intervention
Secondary	Changes in clinical control	The Clinical COPD Questionnaire (CCQ) will be utilized to gauge clinical control in participants. Total scores range from 0 to 6, with a higher CCQ score signifying poorer clinical control and a worse health status.	At baseline, after 1 month, after 3 months, and after 6 months of intervention
Secondary	Social support status	The Multidimensional Scale of Perceived Social Support (MSPSS) will be used for assess social support. The scores can range from 12 and 84. A higher score indicates greater perceived social support	At baseline, after 1 month, after 3 months, and after 6 months of intervention
Secondary	Change in inspiratory muscle strength	The investigators will assess patients' inspirtaory muscle strength using a lung function detector.	At baseline, after 1 month, after 3 months, and after 6 months of intervention
Secondary	Change in expiratory muscle strength	The investigators will assess patients' expiratory muscle strength using a lung function detector.	At baseline, after 1 month, after 3 months, and after 6 months of intervention