Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05995847
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2023-07-03
Brief Title:
Effectiveness of Harmonica Playing in Improving Lung Function Among COPD Patients
Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Organization:
The First Affiliated Hospital of Guangzhou Medical University
Study Overview
Official Title:
The Effectiveness of Harmonica Playing in Improving Lung Function Among In-home Patients With Chronic Obstructive Pulmonary Disease
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor alveolar abnormalities from toxic elements Because of COPDs 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 havent provided robust evidence to support harmonica playings 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 studys 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 005 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 210 program The intention-to-treat ITT approach will be adopted for data analysis
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 havent provided robust evidence to support harmonica playings 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 studys 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 005 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 210 program The intention-to-treat ITT approach will be adopted for data analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None