xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05995847</url>
    </required_header>
    <id_info>
      <org_study_id>ZQiuxuan</org_study_id>
      <nct_id>NCT05995847</nct_id>
    </id_info>
    <brief_title>Effectiveness of Harmonica Playing in Improving Lung Function Among COPD Patients</brief_title>
    <official_title>The Effectiveness of Harmonica Playing in Improving Lung Function Among In-home Patients With Chronic Obstructive Pulmonary Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Affiliated Hospital of Guangzhou Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First Affiliated Hospital of Guangzhou Medical University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Although it has been documented that harmonica playing plays a role in the pulmonary&#xD;
        rehabilitation (PR) of patients with chronic obstructive pulmonary disease (COPD), current&#xD;
        studies are limited by small sample sizes, uncomprehensive outcome indicators, and short&#xD;
        intervention durations. Thus, the investigators aim to compare the harmonica combination&#xD;
        group with the basic-PR-care group in terms of improving health outcomes among COPD patients,&#xD;
        such as lung function, self-efficacy, quality of life, compliance with training, and&#xD;
        emotional distress.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chronic Obstructive Pulmonary Disease (COPD) is an avoidable and treatable condition&#xD;
        characterized by chronic respiratory symptoms and airflow obstruction, primarily due to&#xD;
        airway and/or alveolar abnormalities from toxic elements. Because of COPD's high prevalence&#xD;
        and mortality, its prevention and treatment pose a global public health challenge that needs&#xD;
        addressing.&#xD;
  &#xD;
        Pulmonary rehabilitation (PR) is considered a cornerstone of COPD management because it&#xD;
        effectively improves exercise tolerance, exercise-induced dyspnea, fatigue, and&#xD;
        health-related quality of life. Inspiratory muscle training (IMT) plays an important role in&#xD;
        PR. Studies suggest that harmonica playing can emulate inspiratory muscle training, enhancing&#xD;
        pulmonary function in COPD patients. Additionally, as a music therapy approach, harmonica&#xD;
        playing may alleviate the emotional distress often seen in these individuals.&#xD;
  &#xD;
        However, existing studies haven't provided robust evidence to support harmonica playing's&#xD;
        efficacy in enhancing COPD patients' health outcomes due to limitations like small sample&#xD;
        sizes, non-trial study designs, incomplete outcomes, and short intervention durations. It&#xD;
        remains unclear whether harmonica playing can improve COPD patients' physiological and&#xD;
        psychological health outcomes.&#xD;
  &#xD;
        This study's primary aim is to evaluate whether harmonica playing can boost the lung function&#xD;
        of COPD patients compared to those only receiving basic PR care in the control group. The&#xD;
        secondary aim is to investigate if harmonica playing can enhance other outcomes related to&#xD;
        physical and psychological aspects, such as self-efficacy, quality of life, training&#xD;
        compliance, and emotional distress.&#xD;
  &#xD;
        Methods:&#xD;
  &#xD;
        This is a single-center RCT with a low-risk intervention.&#xD;
  &#xD;
        Patients diagnosed with COPD, based on the Global Initiative for Lung Disease (GOLD)&#xD;
        criteria, will be recruited. They will then be randomly assigned to two groups: the harmonica&#xD;
        combination group and the basic-PR-care group.&#xD;
  &#xD;
        Details of the treatments in both groups are provided in the intervention section.&#xD;
  &#xD;
        At baseline and six months post-intervention, the investigators will collect clinical&#xD;
        evaluations including:&#xD;
  &#xD;
        Lung function (Pulmonary function laboratory tests will be performed only at baseline and six&#xD;
        months post-intervention) Physical activity Symptoms Quality of life Psychological well-being&#xD;
        (focusing on depression and anxiety) Self-efficacy Fatigue Self-reported compliance and&#xD;
        satisfaction Outcome measures will be detailed in the subsequent section.&#xD;
  &#xD;
        FEV1%pred is a commonly used outcome indicator in PR and is suitable for sample size&#xD;
        estimation. According to similar study results, the minimum difference (miniDIFF) between&#xD;
        groups is 15.78, with a baseline standard deviation (SD) of 21.2. Given a two-tailed&#xD;
        significance level of 0.05 and a power of 80%, each group requires a minimum of 50&#xD;
        participants. Accounting for a drop-out rate of 25%, an estimated 134 patients (67 per group)&#xD;
        will be enrolled.&#xD;
  &#xD;
        Statistical evaluation will be performed using the SPSS 21.0 program. The intention-to-treat&#xD;
        (ITT) approach will be adopted for data analysis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in FEV1 % predicted</measure>
      <time_frame>At baseline and after 6 months of intervention</time_frame>
      <description>The investigators will assess patients' lung function using a lung function detector to obtain the outcome of FEV1 % predicted.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in fatigue</measure>
      <time_frame>At baseline, after 3 month and 6 months of intervention</time_frame>
      <description>The Manchester COPD Fatigue Scale will be used to assess patients' degree of fatigue. Scores can range from 0 to 54, with higher scores indicating greater fatigue.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compliance and satisfaction</measure>
      <time_frame>After 6 months of intervention</time_frame>
      <description>A self-designed questionnaire will be utilized, which contains questions about participants' compliance and satisfaction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in self-efficacy</measure>
      <time_frame>At baseline, after 3 month and 6 months of intervention</time_frame>
      <description>The Self-efficacy Scale for Chronic (SSC) will be employed to evaluate patients' disease self-efficacy. This is a 6-item scale, with responses ranging from 1 (not at all confident) to 10 (totally confident). Responses are summed to produce a total score for each participant. Scores can range from 6 to 60, with higher scores indicating greater self-efficacy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in psychological well-being</measure>
      <time_frame>At baseline, after 3 month and 6 months of intervention</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in quality of life</measure>
      <time_frame>At baseline, after 3 month and 6 months of intervention</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in symptoms</measure>
      <time_frame>At baseline, after 3 month and 6 months of intervention</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in level of physical activity</measure>
      <time_frame>At baseline, after 3 month and 6 months of intervention</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in levels of breathlessness</measure>
      <time_frame>At baseline, after 3 month and 6 months of intervention</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in clinical control</measure>
      <time_frame>At baseline, after 3 month and 6 months of intervention</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">134</enrollment>
    <condition>COPD</condition>
    <arm_group>
      <arm_group_label>harmonica combination group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>These patients will participate in a harmonica playing program for 6 months in addition to basic PR care and routine follow-up.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>basic-PR-care group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>These patients will receive basic PR care and routine follow-up.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Harmonica playing program in addition to basic PR care and routine follow-up</intervention_name>
      <description>The intervention spans a total duration of 6 months, during which patients are expected to engage in harmonica-playing for 20 minutes per day, 5 days a week.</description>
      <arm_group_label>harmonica combination group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Basic PR care and routine follow-up</intervention_name>
      <description>These patients will receive basic PR care and routine follow-up.</description>
      <arm_group_label>basic-PR-care group</arm_group_label>
      <arm_group_label>harmonica combination group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          ● Clinical diagnosis of COPD.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals with a history of COPD exacerbation within the last 6 weeks. An&#xD;
               exacerbation is defined as a deterioration in at least two respiratory symptoms that&#xD;
               necessitate hospitalization.&#xD;
  &#xD;
            -  Individuals with comorbidities that affect physical activity, such as severe cardiac&#xD;
               or neurological disorders, cancer, or musculoskeletal problems.&#xD;
  &#xD;
            -  Individuals with cognitive disorders.&#xD;
  &#xD;
            -  Individuals unable to speak or understand spoken/written Chinese.&#xD;
  &#xD;
            -  Individuals who have participated in pulmonary rehabilitation (or any other&#xD;
               structured, disease-related physical training) within the previous 6 months.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Qiuxuan Zeng, Bachelor</last_name>
      <phone>+86 15975789501</phone>
      <email>zengqiuxuan@163.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The First Affiliated Hospital of Guangzhou Medical University</investigator_affiliation>
      <investigator_full_name>Zeng Qiuxuan</investigator_full_name>
      <investigator_title>nurse-in-charge</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05995847
  org study id: ZQiuxuan
  nct id: NCT05995847
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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 diagnosed with COPD, based on the Global Initiative for Lung Disease (GOLD)
        criteria, will be recruited. They will then be randomly assigned to two groups: the harmonica
        combination group and the basic-PR-care group.
  
        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%pred is a commonly used outcome indicator in PR and is suitable for sample size
        estimation. According to similar study results, the minimum difference (miniDIFF) between
        groups is 15.78, with a baseline standard deviation (SD) of 21.2. Given a two-tailed
        significance level of 0.05 and a power of 80%, each group requires a minimum of 50
        participants. Accounting for a drop-out rate of 25%, an estimated 134 patients (67 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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Change in FEV1 % predicted
  time frame: At baseline and after 6 months of intervention
  description: The investigators will assess patients' lung function using a lung function detector to obtain the outcome of FEV1 % predicted.
  measure: Change in fatigue
  time frame: At baseline, after 3 month and 6 months of intervention
  description: The Manchester COPD Fatigue Scale will be used to assess patients' degree of fatigue. Scores can range from 0 to 54, with higher scores indicating greater fatigue.
  measure: Compliance and satisfaction
  time frame: After 6 months of intervention
  description: A self-designed questionnaire will be utilized, which contains questions about participants' compliance and satisfaction.
  measure: Change in self-efficacy
  time frame: At baseline, after 3 month and 6 months of intervention
  description: The Self-efficacy Scale for Chronic (SSC) will be employed to evaluate patients' disease self-efficacy. This is a 6-item scale, with responses ranging from 1 (not at all confident) to 10 (totally confident). Responses are summed to produce a total score for each participant. Scores can range from 6 to 60, with higher scores indicating greater self-efficacy.
  measure: Change in psychological well-being
  time frame: At baseline, after 3 month and 6 months of intervention
  description: 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.
  measure: Change in quality of life
  time frame: At baseline, after 3 month and 6 months of intervention
  description: 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.
  measure: Change in symptoms
  time frame: At baseline, after 3 month and 6 months of intervention
  description: 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.
  measure: Change in level of physical activity
  time frame: At baseline, after 3 month and 6 months of intervention
  description: 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.
  measure: Changes in levels of breathlessness
  time frame: At baseline, after 3 month and 6 months of intervention
  description: 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.
  measure: Changes in clinical control
  time frame: At baseline, after 3 month and 6 months of intervention
  description: 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.
  arm group label: harmonica combination group
  arm group type: Experimental
  description: These patients will participate in a harmonica playing program for 6 months in addition to basic PR care and routine follow-up.
  arm group label: basic-PR-care group
  arm group type: Active Comparator
  description: These patients will receive basic PR care and routine follow-up.
  intervention type: Behavioral
  intervention name: Harmonica playing program in addition to basic PR care and routine follow-up
  description: The intervention spans a total duration of 6 months, during which patients are expected to engage in harmonica-playing for 20 minutes per day, 5 days a week.
  arm group label: harmonica combination group
  intervention type: Behavioral
  intervention name: Basic PR care and routine follow-up
  description: These patients will receive basic PR care and routine follow-up.
  arm group label: basic-PR-care group
  arm group label: harmonica combination group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Qiuxuan Zeng, Bachelor
  phone: +86 15975789501
  email: zengqiuxuan@163.com
  responsible party type: Principal Investigator
  investigator affiliation: The First Affiliated Hospital of Guangzhou Medical University
  investigator full name: Zeng Qiuxuan
  investigator title: nurse-in-charge