<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/NCT03280355</url>
  </required_header>
  <id_info>
    <org_study_id>AU_Singing</org_study_id>
    <nct_id>NCT03280355</nct_id>
  </id_info>
  <brief_title>The Effects of Singing Training for Patients With Chronic Obstructive Pulmonary Disease (COPD)</brief_title>
  <official_title>The Effects of Singing Training for Patients With Chronic Obstructive Pulmonary Disease (COPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Region Zealand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with Chronic Obstructive Pulmonary Disease (COPD) experience physiological and&#xD;
      psychological complications, such as shortness of breath, anxiety and depression. This has&#xD;
      negative influence on their social life, daily activity level and overall quality of life.&#xD;
      Patients can participate in a pulmonary rehabilitation program (PR) for the purpose of better&#xD;
      managing of the disease and its symptoms and for avoiding future relapses and&#xD;
      hospitalisations. However there is a large number of dropouts from PR, and therefore a need&#xD;
      for investigation of new activities. Singing training may be one such potential relevant and&#xD;
      motivating rehabilitation activity. This study aims to investigate the effects of singing&#xD;
      training on both physiological and psychological aspects, and will compare the effects with&#xD;
      that of physical training (golden standard in PR). Effects will be investigated in a&#xD;
      randomised controlled trial (RCT) with 10 week intervention period. In all the study includes&#xD;
      11 municipalities from around all regions of Denmark, and in all 220 participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The number of patients with Chronic Obstructive Pulmonary Disease (COPD) is is rapidly&#xD;
      increasing, and the disease is projected to be the third leading cause of death worldwide in&#xD;
      2020. At the present time 320.000 people in Denmark suffer from COPD, though only half of&#xD;
      them are diagnosed and hence treated with appropriate medication. Often patients are not&#xD;
      diagnosed until the pulmonary function is only 50% and therefore at a severe stage of the&#xD;
      disease, where there tends to be a high rate in hospitalisations and recurring exacerbations&#xD;
      with increasing symptoms. COPD amounts to 10% of the Danish national health care budget, and&#xD;
      Denmark has the highest COPD related mortality rate in the EU.&#xD;
&#xD;
      Besides sufficient medical treatment, patients are offered attendance in pulmonary&#xD;
      rehabilitation, since lifestyle changes are crucial in order to prevent disease progression,&#xD;
      and for better management of symptoms and higher Quality of Life (QoL). Pulmonary&#xD;
      rehabilitation consists of evidence based activities and are based on international and&#xD;
      national guidelines. However there is a need for investigation of new motivating and&#xD;
      perceived relevant rehabilitation activities due to a large number of drop-outs of the&#xD;
      ordinary rehabilitation program.&#xD;
&#xD;
      The study aims to examine the effects of singing training for patients with COPD in relation&#xD;
      to physiological as well as psychological aspects. Intervention is singing training, and&#xD;
      active control is usual care: Physical training (golden standard and standard part of&#xD;
      ordinary pulmonary rehabilitation).&#xD;
&#xD;
      HYPOTHESES:&#xD;
&#xD;
      The main hypothesis of this study is that singing training as activity in pulmonary&#xD;
      rehabilitation is non-inferior in relation to effects on specific physiological and specific&#xD;
      psychological/psychosocial aspects compared to physical training (control group).&#xD;
&#xD;
      More specifically, the hypotheses are:&#xD;
&#xD;
        1. Singing training leads to a positive rehabilitation process as regards selected&#xD;
           physiological parameters as well as selected psychological and psychosocial parameters.&#xD;
&#xD;
        2. Attending the singing training program leads to a more consistent rehabilitation process&#xD;
           with higher motivation and less drop outs among the participants than in the control&#xD;
           group.&#xD;
&#xD;
      Potential moderators and mediators:&#xD;
&#xD;
      During the project potential mediating and moderating factors will be explored, e.g.&#xD;
      including socio-demographic, disease-, lifestyle- and attitude-related characteristics (COPD&#xD;
      participants are e.g. characterised by relatively old age and lower socio-economic status).&#xD;
      Furthermore, relevant psychological aspects (e.g. in correlation with building and&#xD;
      maintaining motivation) will be investigated.&#xD;
&#xD;
      Also baseline attitude towards singing (and physical training), the relationship between the&#xD;
      facilitator and participants, and the significance of influence associated with the&#xD;
      intervention (e.g. in terms of musical taste) will be taken into consideration.&#xD;
&#xD;
      BACKGROUND:&#xD;
&#xD;
      Physical and psychological effects of COPD:&#xD;
&#xD;
      COPD is a syndrome with a progressive pulmonary obstruction leading to increasingly impaired&#xD;
      lung function due to chronic inflammation in the respiratory passages and pulmonary tissue.&#xD;
      Living with COPD everyday life is a struggle and often marked by continuous dyspnea, cough&#xD;
      and sputum. The patients often suffer from emphysema leading to stiff lungs and insufficient&#xD;
      diffusion of oxygen. This again leads to a vicious circle with lack of control of respiratory&#xD;
      function, increased hyperinflation and forced, clavicular oriented breathing. Comorbidities&#xD;
      such as heart disease, muscle wasting, hypertension and infections are common, which again&#xD;
      lead to further complications.&#xD;
&#xD;
      On a psychological level patients are often also affected negatively as a sequela of the&#xD;
      disease. E.g. COPD patients tend to suffer from comorbidities such as increased stress and&#xD;
      anxiety levels e.g. due to dyspnea. Furthermore patients experience social isolation,&#xD;
      financial downfall and generally impaired Quality of Life (QoL). Also activities of daily&#xD;
      life are significantly affected by COPD, and the reduced activity again leads to depression&#xD;
      and further physical health problems, by which a vicious circle develops. In other words COPD&#xD;
      often leads to a severe condition that both physically and psychologically can be very&#xD;
      difficult to manage and cope with.&#xD;
&#xD;
      COPD and rehabilitation:&#xD;
&#xD;
      Although the COPD related degeneration of the lungs is irreversible, treatment may slow down&#xD;
      further progression, and improve the interrelated physical and psychological consequences of&#xD;
      the disease. Besides required medical treatment participants life style change, e.g. smoking&#xD;
      cessation, physical training and psychosocial support, are crucial.&#xD;
&#xD;
      According to guidelines from the Danish Government Health Agency patients are encouraged to&#xD;
      join an 8-12-wk multidisciplinary rehabilitation program in order to improve physical and&#xD;
      mental condition, improve general function and QoL levels, and prevent exacerbations,&#xD;
      hospitalisations and early mortality. The overall recommendations are that patients should&#xD;
      not only receive clinical control and medical treatment, but should also participate in&#xD;
      additional interventions. This is essential in terms of supporting the participants in&#xD;
      maintaining (or retrieve) empowerment and self-dependence, also as regards education, work,&#xD;
      income, housing and social network.&#xD;
&#xD;
      However, there is a high drop out rate, both due to exacerbations or mortality and to lack of&#xD;
      mobility or motivation. Therefore it is of high importance to develop alternative&#xD;
      rehabilitation activities that are motivating and are perceived relevant for the participants&#xD;
      and that both includes physical training and enables the participants to lead their lives&#xD;
      with a higher QoL level. Furthermore, physical and psychological effects of COPD seem to&#xD;
      influence each other significantly, suggesting that both areas should be considered in&#xD;
      rehabilitation of COPD patients.&#xD;
&#xD;
      There is an unmet need for new types of interventional therapies to help COPD patients. This&#xD;
      study aims to investigate singing training as a potential new rehabilitation activity, since&#xD;
      singing might lead to a more efficient utilisation of the remaining respiratory function of&#xD;
      participants with COPD and improve QoL.&#xD;
&#xD;
      Singing and COPD rehabilitation:&#xD;
&#xD;
      A number of international studies have investigated the effects of singing in relation to&#xD;
      COPD patients. The core of singing activity is to learn how to control the respiratory&#xD;
      function, including training and coordination of both inspiration and expiration function,&#xD;
      focusing on the related primary and secondary musculature. An essential part of the singing&#xD;
      training is also focused exercises for posture, relaxation and general body awareness.&#xD;
      Moreover, group singing might have a positive impact on the experiences of social&#xD;
      interaction, and music in general seems to have an ability to create emotions, and seems to&#xD;
      have a positive impact on well-being, anxiety and depression level.&#xD;
&#xD;
      Previous studies differ in methodology (randomized controlled trials, observational studies,&#xD;
      qualitative studies and literature reviews), and furthermore sample size and statistical&#xD;
      power are not sufficient to conclude on significance and results. Therefore it is of great&#xD;
      importance to conduct further and larger trials in order to provide evidence to the field.&#xD;
&#xD;
      In Denmark a number of COPD choirs have been launched, and it seems to have become&#xD;
      common-sense that singing is healthy to patients with COPD. The choirs however are launched&#xD;
      quite randomly, there is no common methodology on the COPD choirs, and also effects of the&#xD;
      choir singing has not yet been investigated. COPD singing therefore has not yet been&#xD;
      considered in the national guidelines as a validated rehabilitation activity, however popular&#xD;
      among the participants. Therefore the present study is of high relevance, since it aims to&#xD;
      provide knowledge and evidence within this field, for the benefit of the large and&#xD;
      dramatically growing number of COPD patients.&#xD;
&#xD;
      METHODS:&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      The study is a non-pharmacological two-armed randomized controlled trial with intervention&#xD;
      group receiving singing training (ST), and active control group receiving &quot;golden standard&quot;:&#xD;
      Physical training (PT). Both groups will participate in a 10 weeks' program, 1 1/2 hour,&#xD;
      twice a week. Both groups also participate in education activities as part of pulmonary&#xD;
      rehabilitation, such as smoking cessation course. Participants randomised to singing training&#xD;
      will be offered opportunity to participate in standard physical training post intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">April 15, 2019</completion_date>
  <primary_completion_date type="Actual">April 15, 2019</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>
    <intervention_model_description>Non-pharmacological, intervention based, group randomised (cluster randomised) controlled trial, 2 arms (intervention and active control group)</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Assessor (nurse) is masked, primary investigator is masked</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>6 Minutes Walk Distance (6MWD)</measure>
    <time_frame>12 weeks (+/- 2 weeks)</time_frame>
    <description>Meters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pedometer</measure>
    <time_frame>12 weeks (+/- 2 weeks)</time_frame>
    <description>Number of steps (worn for 1 week (7 days) at baseline and post intervention)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>St. George's Respiratory Questionnaire (SGRQ)</measure>
    <time_frame>12 weeks (+/- 2 weeks)</time_frame>
    <description>Quality of Life-questionnaire (self-reported)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced Expiratory Volume Predicted (FEV1%)</measure>
    <time_frame>12 weeks (+/- 2 weeks)</time_frame>
    <description>The FEV1% is the FEV1 divided by the FVC (Forced Vital Capacity) times 100: FEV1%=FEV1/VC X100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breath Hold Test</measure>
    <time_frame>12 weeks (+/- 2 weeks)</time_frame>
    <description>Number of seconds (from max inspiration)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single-breath Count</measure>
    <time_frame>12 weeks (+/- 2 weeks)</time_frame>
    <description>Numbers counted (beats per minute=60) (from max inspiration)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance</measure>
    <time_frame>10 weeks</time_frame>
    <description>Self-produced excel sheet with registration each time of each participant's attendance or absence (with or without cause). Registered continuously during intervention period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Musical Ear Test (MET)</measure>
    <time_frame>12 weeks (+/- 2 weeks)</time_frame>
    <description>Test for musical competence: 104 trials on which participants judge whether two short musical phrases (melody/rhythm) are identical or not</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">270</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Singing Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Singing Training as training activity in Pulmonary Rehabilitation: 10 weeks, twice a week for 1 1/2 hour, leading to a total of 20 sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Physical Training as training activity in Pulmonary Rehabilitation: 10 weeks, twice a week for 1 1/2 hour, leading to a total of 20 sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Singing training</intervention_name>
    <description>Each session will contain technical instruction in order to achieve better respiratory control and primary muscular strength, and with focus on techniques for efficient expiration. Sessions will also focus on musical content and interpretation as well as interaction, the social aspects and joy of singing together.&#xD;
Prior to the trial all singing teachers will participate in a 2 days' workshop, where they will be instructed in sufficient methodology and didactics, and will obtain profound knowledge about the disease pathology and related physiology.</description>
    <arm_group_label>Singing Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical Training</intervention_name>
    <description>Physical Training (golden standard training activity in pulmonary rehabilitation) - usual care - is the active comparator in the trial.&#xD;
The programme is based on the national guidelines for pulmonary rehabilitation, and consists of supervised warm-ups, aerobic exercises, workout (strength), and breathing exercises.&#xD;
Physical Training is conducted by the local physiotherapists in the local health centres.</description>
    <arm_group_label>Physical Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants with a clinical diagnosis of COPD and who meet the following criteria are&#xD;
        eligible:&#xD;
&#xD;
          1. Recommended for Pulmonary Rehabilitation and minimum mMRC2 level of dyspnea&#xD;
&#xD;
          2. Motivated for participating in the project (and acceptance of randomization)&#xD;
&#xD;
          3. Sufficient mobility to attend PR&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Certain comorbidities (e.g. unstable coronary complications)&#xD;
&#xD;
          2. Severe cognitive disabilities (e.g. dementia)&#xD;
&#xD;
          3. Inability to speak or understand Danish&#xD;
&#xD;
        No previous singing experience or musical competence is required.&#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_official>
    <last_name>Uffe Bodtger, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Region Zealand</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Vuust, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Aarhus Univeristy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rudersdal Health Centre</name>
      <address>
        <city>Birkerod</city>
        <zip>3460</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakse Health Centre</name>
      <address>
        <city>Fakse</city>
        <zip>4640</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vesthimmerland Health Centre</name>
      <address>
        <city>Farso</city>
        <zip>9640</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hedensted Health Centre</name>
      <address>
        <city>Hedensted</city>
        <zip>8722</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helsingor Health Centre</name>
      <address>
        <city>Helsingor</city>
        <zip>3000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ikast-Brande Health Centre</name>
      <address>
        <city>Ikast</city>
        <zip>7430</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lemvig Health Centre</name>
      <address>
        <city>Lemvig</city>
        <zip>7620</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lolland Health Centre</name>
      <address>
        <city>Maribo</city>
        <zip>4930</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Silkeborg Health Centre</name>
      <address>
        <city>Silkeborg</city>
        <zip>8600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Slagelse Health Centre</name>
      <address>
        <city>Slagelse</city>
        <zip>4200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vordingborg Health Centre</name>
      <address>
        <city>Vordingborg</city>
        <zip>4760</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>June 20, 2023</last_update_submitted>
  <last_update_submitted_qc>June 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>Chronic Obstructive Pulmonary Disease</keyword>
  <keyword>Randomised controlled trial (RCT)</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Singing Training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 19, 2023</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT03280355/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03280355
org study id: AU_Singing
nct id: NCT03280355
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients with Chronic Obstructive Pulmonary Disease (COPD) experience physiological and
      psychological complications, such as shortness of breath, anxiety and depression. This has
      negative influence on their social life, daily activity level and overall quality of life.
      Patients can participate in a pulmonary rehabilitation program (PR) for the purpose of better
      managing of the disease and its symptoms and for avoiding future relapses and
      hospitalisations. However there is a large number of dropouts from PR, and therefore a need
      for investigation of new activities. Singing training may be one such potential relevant and
      motivating rehabilitation activity. This study aims to investigate the effects of singing
      training on both physiological and psychological aspects, and will compare the effects with
      that of physical training (golden standard in PR). Effects will be investigated in a
      randomised controlled trial (RCT) with 10 week intervention period. In all the study includes
      11 municipalities from around all regions of Denmark, and in all 220 participants.
The number of patients with Chronic Obstructive Pulmonary Disease (COPD) is is rapidly
      increasing, and the disease is projected to be the third leading cause of death worldwide in
      2020. At the present time 320.000 people in Denmark suffer from COPD, though only half of
      them are diagnosed and hence treated with appropriate medication. Often patients are not
      diagnosed until the pulmonary function is only 50% and therefore at a severe stage of the
      disease, where there tends to be a high rate in hospitalisations and recurring exacerbations
      with increasing symptoms. COPD amounts to 10% of the Danish national health care budget, and
      Denmark has the highest COPD related mortality rate in the EU.

      Besides sufficient medical treatment, patients are offered attendance in pulmonary
      rehabilitation, since lifestyle changes are crucial in order to prevent disease progression,
      and for better management of symptoms and higher Quality of Life (QoL). Pulmonary
      rehabilitation consists of evidence based activities and are based on international and
      national guidelines. However there is a need for investigation of new motivating and
      perceived relevant rehabilitation activities due to a large number of drop-outs of the
      ordinary rehabilitation program.

      The study aims to examine the effects of singing training for patients with COPD in relation
      to physiological as well as psychological aspects. Intervention is singing training, and
      active control is usual care: Physical training (golden standard and standard part of
      ordinary pulmonary rehabilitation).

      HYPOTHESES:

      The main hypothesis of this study is that singing training as activity in pulmonary
      rehabilitation is non-inferior in relation to effects on specific physiological and specific
      psychological/psychosocial aspects compared to physical training (control group).

      More specifically, the hypotheses are:

        1. Singing training leads to a positive rehabilitation process as regards selected
           physiological parameters as well as selected psychological and psychosocial parameters.

        2. Attending the singing training program leads to a more consistent rehabilitation process
           with higher motivation and less drop outs among the participants than in the control
           group.

      Potential moderators and mediators:

      During the project potential mediating and moderating factors will be explored, e.g.
      including socio-demographic, disease-, lifestyle- and attitude-related characteristics (COPD
      participants are e.g. characterised by relatively old age and lower socio-economic status).
      Furthermore, relevant psychological aspects (e.g. in correlation with building and
      maintaining motivation) will be investigated.

      Also baseline attitude towards singing (and physical training), the relationship between the
      facilitator and participants, and the significance of influence associated with the
      intervention (e.g. in terms of musical taste) will be taken into consideration.

      BACKGROUND:

      Physical and psychological effects of COPD:

      COPD is a syndrome with a progressive pulmonary obstruction leading to increasingly impaired
      lung function due to chronic inflammation in the respiratory passages and pulmonary tissue.
      Living with COPD everyday life is a struggle and often marked by continuous dyspnea, cough
      and sputum. The patients often suffer from emphysema leading to stiff lungs and insufficient
      diffusion of oxygen. This again leads to a vicious circle with lack of control of respiratory
      function, increased hyperinflation and forced, clavicular oriented breathing. Comorbidities
      such as heart disease, muscle wasting, hypertension and infections are common, which again
      lead to further complications.

      On a psychological level patients are often also affected negatively as a sequela of the
      disease. E.g. COPD patients tend to suffer from comorbidities such as increased stress and
      anxiety levels e.g. due to dyspnea. Furthermore patients experience social isolation,
      financial downfall and generally impaired Quality of Life (QoL). Also activities of daily
      life are significantly affected by COPD, and the reduced activity again leads to depression
      and further physical health problems, by which a vicious circle develops. In other words COPD
      often leads to a severe condition that both physically and psychologically can be very
      difficult to manage and cope with.

      COPD and rehabilitation:

      Although the COPD related degeneration of the lungs is irreversible, treatment may slow down
      further progression, and improve the interrelated physical and psychological consequences of
      the disease. Besides required medical treatment participants life style change, e.g. smoking
      cessation, physical training and psychosocial support, are crucial.

      According to guidelines from the Danish Government Health Agency patients are encouraged to
      join an 8-12-wk multidisciplinary rehabilitation program in order to improve physical and
      mental condition, improve general function and QoL levels, and prevent exacerbations,
      hospitalisations and early mortality. The overall recommendations are that patients should
      not only receive clinical control and medical treatment, but should also participate in
      additional interventions. This is essential in terms of supporting the participants in
      maintaining (or retrieve) empowerment and self-dependence, also as regards education, work,
      income, housing and social network.

      However, there is a high drop out rate, both due to exacerbations or mortality and to lack of
      mobility or motivation. Therefore it is of high importance to develop alternative
      rehabilitation activities that are motivating and are perceived relevant for the participants
      and that both includes physical training and enables the participants to lead their lives
      with a higher QoL level. Furthermore, physical and psychological effects of COPD seem to
      influence each other significantly, suggesting that both areas should be considered in
      rehabilitation of COPD patients.

      There is an unmet need for new types of interventional therapies to help COPD patients. This
      study aims to investigate singing training as a potential new rehabilitation activity, since
      singing might lead to a more efficient utilisation of the remaining respiratory function of
      participants with COPD and improve QoL.

      Singing and COPD rehabilitation:

      A number of international studies have investigated the effects of singing in relation to
      COPD patients. The core of singing activity is to learn how to control the respiratory
      function, including training and coordination of both inspiration and expiration function,
      focusing on the related primary and secondary musculature. An essential part of the singing
      training is also focused exercises for posture, relaxation and general body awareness.
      Moreover, group singing might have a positive impact on the experiences of social
      interaction, and music in general seems to have an ability to create emotions, and seems to
      have a positive impact on well-being, anxiety and depression level.

      Previous studies differ in methodology (randomized controlled trials, observational studies,
      qualitative studies and literature reviews), and furthermore sample size and statistical
      power are not sufficient to conclude on significance and results. Therefore it is of great
      importance to conduct further and larger trials in order to provide evidence to the field.

      In Denmark a number of COPD choirs have been launched, and it seems to have become
      common-sense that singing is healthy to patients with COPD. The choirs however are launched
      quite randomly, there is no common methodology on the COPD choirs, and also effects of the
      choir singing has not yet been investigated. COPD singing therefore has not yet been
      considered in the national guidelines as a validated rehabilitation activity, however popular
      among the participants. Therefore the present study is of high relevance, since it aims to
      provide knowledge and evidence within this field, for the benefit of the large and
      dramatically growing number of COPD patients.

      METHODS:

      Study design:

      The study is a non-pharmacological two-armed randomized controlled trial with intervention
      group receiving singing training (ST), and active control group receiving "golden standard":
      Physical training (PT). Both groups will participate in a 10 weeks' program, 1 1/2 hour,
      twice a week. Both groups also participate in education activities as part of pulmonary
      rehabilitation, such as smoking cessation course. Participants randomised to singing training
      will be offered opportunity to participate in standard physical training post intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Non-pharmacological, intervention based, group randomised (cluster randomised) controlled trial, 2 arms (intervention and active control group)
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
masking description: Assessor (nurse) is masked, primary investigator is masked
measure: 6 Minutes Walk Distance (6MWD)
time frame: 12 weeks (+/- 2 weeks)
description: Meters
measure: Pedometer
time frame: 12 weeks (+/- 2 weeks)
description: Number of steps (worn for 1 week (7 days) at baseline and post intervention)
measure: St. George's Respiratory Questionnaire (SGRQ)
time frame: 12 weeks (+/- 2 weeks)
description: Quality of Life-questionnaire (self-reported)
measure: Forced Expiratory Volume Predicted (FEV1%)
time frame: 12 weeks (+/- 2 weeks)
description: The FEV1% is the FEV1 divided by the FVC (Forced Vital Capacity) times 100: FEV1%=FEV1/VC X100
measure: Breath Hold Test
time frame: 12 weeks (+/- 2 weeks)
description: Number of seconds (from max inspiration)
measure: Single-breath Count
time frame: 12 weeks (+/- 2 weeks)
description: Numbers counted (beats per minute=60) (from max inspiration)
measure: Compliance
time frame: 10 weeks
description: Self-produced excel sheet with registration each time of each participant's attendance or absence (with or without cause). Registered continuously during intervention period.
measure: Musical Ear Test (MET)
time frame: 12 weeks (+/- 2 weeks)
description: Test for musical competence: 104 trials on which participants judge whether two short musical phrases (melody/rhythm) are identical or not
arm group label: Singing Training
arm group type: Experimental
description: Singing Training as training activity in Pulmonary Rehabilitation: 10 weeks, twice a week for 1 1/2 hour, leading to a total of 20 sessions.
arm group label: Physical Training
arm group type: Active Comparator
description: Physical Training as training activity in Pulmonary Rehabilitation: 10 weeks, twice a week for 1 1/2 hour, leading to a total of 20 sessions.
intervention type: Behavioral
intervention name: Singing training
description: Each session will contain technical instruction in order to achieve better respiratory control and primary muscular strength, and with focus on techniques for efficient expiration. Sessions will also focus on musical content and interpretation as well as interaction, the social aspects and joy of singing together.
Prior to the trial all singing teachers will participate in a 2 days' workshop, where they will be instructed in sufficient methodology and didactics, and will obtain profound knowledge about the disease pathology and related physiology.
arm group label: Singing Training
intervention type: Behavioral
intervention name: Physical Training
description: Physical Training (golden standard training activity in pulmonary rehabilitation) - usual care - is the active comparator in the trial.
The programme is based on the national guidelines for pulmonary rehabilitation, and consists of supervised warm-ups, aerobic exercises, workout (strength), and breathing exercises.
Physical Training is conducted by the local physiotherapists in the local health centres.
arm group label: Physical Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Uffe Bodtger, MD PhD
role: Principal Investigator
affiliation: Region Zealand
last name: Peter Vuust, Professor
role: Study Director
affiliation: Aarhus Univeristy
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No
provided document: 