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The Effects of Singing Training for Patients With Chronic Obstructive Pulmonary Disease (COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03280355
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : February 25, 2021
Region Zealand
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Behavioral: Singing training Behavioral: Physical Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
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)
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Assessor (nurse) is masked, primary investigator is masked
Primary Purpose: Supportive Care
Official Title: The Effects of Singing Training for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : April 15, 2019
Actual Study Completion Date : April 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Singing Training
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.
Behavioral: Singing training

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.

Active Comparator: Physical Training
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.
Behavioral: Physical Training

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.

Primary Outcome Measures :
  1. 6 Minutes Walk Distance (6MWD) [ Time Frame: 12 weeks (+/- 2 weeks) ]

Secondary Outcome Measures :
  1. Pedometer [ Time Frame: 12 weeks (+/- 2 weeks) ]
    Number of steps (worn for 1 week (7 days) at baseline and post intervention)

  2. St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: 12 weeks (+/- 2 weeks) ]
    Quality of Life-questionnaire (self-reported)

  3. Forced Expiratory Volume Predicted (FEV1%) [ Time Frame: 12 weeks (+/- 2 weeks) ]
    The FEV1% is the FEV1 divided by the FVC (Forced Vital Capacity) times 100: FEV1%=FEV1/VC X100

  4. Breath Hold Test [ Time Frame: 12 weeks (+/- 2 weeks) ]
    Number of seconds (from max inspiration)

  5. Single-breath Count [ Time Frame: 12 weeks (+/- 2 weeks) ]
    Numbers counted (beats per minute=60) (from max inspiration)

  6. Compliance [ Time Frame: 10 weeks ]
    Self-produced excel sheet with registration each time of each participant's attendance or absence (with or without cause). Registered continuously during intervention period.

  7. Musical Ear Test (MET) [ Time Frame: 12 weeks (+/- 2 weeks) ]
    Test for musical competence: 104 trials on which participants judge whether two short musical phrases (melody/rhythm) are identical or not

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Participants with a clinical diagnosis of COPD and who meet the following criteria are eligible:

  1. Recommended for Pulmonary Rehabilitation and minimum mMRC2 level of dyspnea
  2. Motivated for participating in the project (and acceptance of randomization)
  3. Sufficient mobility to attend PR

Exclusion Criteria:

  1. Certain comorbidities (e.g. unstable coronary complications)
  2. Severe cognitive disabilities (e.g. dementia)
  3. Inability to speak or understand Danish

No previous singing experience or musical competence is required.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280355

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Rudersdal Health Centre
Birkerod, Denmark, 3460
Fakse Health Centre
Fakse, Denmark, 4640
Vesthimmerland Health Centre
Farso, Denmark, 9640
Hedensted Health Centre
Hedensted, Denmark, 8722
Helsingor Health Centre
Helsingor, Denmark, 3000
Ikast-Brande Health Centre
Ikast, Denmark, 7430
Lemvig Health Centre
Lemvig, Denmark, 7620
Lolland Health Centre
Maribo, Denmark, 4930
Silkeborg Health Centre
Silkeborg, Denmark, 8600
Slagelse Health Centre
Slagelse, Denmark, 4200
Vordingborg Health Centre
Vordingborg, Denmark, 4760
Sponsors and Collaborators
University of Aarhus
Region Zealand
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Principal Investigator: Uffe Bodtger, MD PhD Region Zealand
Study Director: Peter Vuust, Professor Aarhus Univeristy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03280355    
Other Study ID Numbers: AU_Singing
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Chronic Obstructive Pulmonary Disease
Randomised controlled trial (RCT)
Singing Training
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Chronic Disease
Disease Attributes
Pathologic Processes