Effectiveness of Harmonica Playing in Improving Lung Function Among COPD Patients

NCT05995847 | Recruiting

• 1 other identifier: ZQiuxuan
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 2

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Change in individual strength

  At baseline, after 1 month, after 3 months, and after 6 months of intervention

• Change in fatigue

  At baseline, after 1 month, after 3 months, and after 6 months of intervention

• Compliance and satisfaction

  After 6 months of intervention

• Change in self-efficacy

  At baseline, after 1 month, after 3 months, and after 6 months of intervention

• Change in psychological well-being

  At baseline, after 1 month, after 3 months, and after 6 months of intervention

Study Arms (2)

harmonica combination group

EXPERIMENTAL

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.

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

basic-PR-care group

ACTIVE COMPARATOR

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.

Behavioral: Basic PR care with routine follow-up

Interventions

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

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.

harmonica combination group

Basic PR care with routine follow-up BEHAVIORAL

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

basic-PR-care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ● Clinical diagnosis of COPD.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (2)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510006, China

RECRUITING

The first affiliated hospital of Guangzhou Medical Univeristy

Guangzhou, China

RECRUITING

Related Publications (1)

• Zeng Q, Lin X, Chen W, Fong DYT, Li J, Li J. Effectiveness of a harmonica-integrated, tele-supervised home-based pulmonary rehabilitation program on lung function and comprehensive health outcomes in patients with chronic obstructive pulmonary disease: a randomized controlled trial protocol. Front Public Health. 2025 Jan 29;13:1541866. doi: 10.3389/fpubh.2025.1541866. eCollection 2025.

  PMID: 39944075 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Qiuxuan Zeng, Bachelor

CONTACT

+86 15975789501; zengqiuxuan@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: nurse-in-charge

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: August 16, 2023
• Study Start: December 5, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

CN (2)