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

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ClinicalTrials.gov Identifier: NCT03280355
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-pharmacologisal, 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
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

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) ]
    Meters


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



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

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


Contacts
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Contact: Mette Kaasgaard, PhD student 4528940238 mk@clin.au.dk
Contact: Uffe Bodtger, MD PhD 24791426 ubt@regionsjaelland.dk

Locations
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Denmark
Rudersdal Health Centre Recruiting
Birkerod, Denmark, 3460
Contact: Lene Kiel Jensen         
Fakse Health Centre Recruiting
Fakse, Denmark, 4640
Contact: Vibeke Bastrup         
Vesthimmerland Health Centre Recruiting
Farso, Denmark, 9640
Contact: Karen-Marie Winther         
Hedensted Health Centre Recruiting
Hedensted, Denmark, 8722
Contact: Karin Iversen         
Helsingor Health Centre Recruiting
Helsingor, Denmark, 3000
Contact: Birgitte Thorsell         
Ikast-Brande Health Centre Recruiting
Ikast, Denmark, 7430
Contact: Lene Christensen         
Lemvig Health Centre Recruiting
Lemvig, Denmark, 7620
Contact: Anne Sjorvad         
Lolland Health Centre Recruiting
Maribo, Denmark, 4930
Contact: Steffen Holtze         
Silkeborg Health Centre Recruiting
Silkeborg, Denmark, 8600
Contact: Linda Holmberg         
Slagelse Health Centre Recruiting
Slagelse, Denmark, 4200
Contact: Leif Staal Andersen         
Vordingborg Health Centre Recruiting
Vordingborg, Denmark, 4760
Contact: Ulla Hemmingsen         
Sponsors and Collaborators
University of Aarhus
Region Zealand
Investigators
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Principal Investigator: Uffe Bodtger, MD PhD Region Zealand
Study Director: Peter Vuust, Professor Aarhus Univeristy

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03280355     History of Changes
Other Study ID Numbers: AU_Singing
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
COPD
Chronic Obstructive Pulmonary Disease
Randomised controlled trial (RCT)
Rehabilitation
Singing Training

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases