The Effectiveness of Harmonica Playing in Improving Lung Function Among In-home Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 248
- 试验地点
- 2
- 主要终点
- Change in FEV1 % predicted
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •● Clinical diagnosis of COPD.
排除标准
- •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.
研究组 & 干预措施
harmonica combination group
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.
干预措施: Harmonica playing program plus basic PR care with routine follow-up (Behavioral)
basic-PR-care group
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.
干预措施: Basic PR care with routine follow-up (Behavioral)
结局指标
主要结局
Change in FEV1 % predicted
时间窗: At baseline, after 1 month, after 3 months, and after 6 months of intervention
The investigators will assess patients' lung function using a lung function detector to obtain the outcome of FEV1 % predicted.
次要结局
- Change in fatigue(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)
- Changes in clinical control(At baseline, after 1 month, after 3 months, and after 6 months of intervention)
- Change in individual strength(At baseline, after 1 month, after 3 months, and after 6 months of intervention)
- Change in self-efficacy(At baseline, after 1 month, after 3 months, and after 6 months of intervention)
- Compliance and satisfaction(After 6 months of intervention)
- Change in quality of life(At baseline, after 1 month, after 3 months, and after 6 months of intervention)
- Change in inspiratory muscle strength(At baseline, after 1 month, after 3 months, and after 6 months of intervention)
- Change in symptoms(At baseline, after 1 month, after 3 months, and after 6 months of intervention)
- Change in level of physical activity(At baseline, after 1 month, after 3 months, and after 6 months of intervention)
- Changes in levels of breathlessness(At baseline, after 1 month, after 3 months, and after 6 months of intervention)
- Social support status(At baseline, after 1 month, after 3 months, and after 6 months of intervention)
- Change in expiratory muscle strength(At baseline, after 1 month, after 3 months, and after 6 months of intervention)
研究者
Zeng Qiuxuan
nurse-in-charge
The First Affiliated Hospital of Guangzhou Medical University