The Effects of Singing Training for Patients With Chronic Obstructive Pulmonary Disease (COPD)
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|ClinicalTrials.gov Identifier: NCT03280355|
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : February 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Behavioral: Singing training Behavioral: Physical Training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||270 participants|
|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|
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.
- 6 Minutes Walk Distance (6MWD) [ Time Frame: 12 weeks (+/- 2 weeks) ]Meters
- Pedometer [ Time Frame: 12 weeks (+/- 2 weeks) ]Number of steps (worn for 1 week (7 days) at baseline and post intervention)
- St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: 12 weeks (+/- 2 weeks) ]Quality of Life-questionnaire (self-reported)
- 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
- Breath Hold Test [ Time Frame: 12 weeks (+/- 2 weeks) ]Number of seconds (from max inspiration)
- Single-breath Count [ Time Frame: 12 weeks (+/- 2 weeks) ]Numbers counted (beats per minute=60) (from max inspiration)
- 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.
- 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
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
|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|
|Principal Investigator:||Uffe Bodtger, MD PhD||Region Zealand|
|Study Director:||Peter Vuust, Professor||Aarhus Univeristy|