Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborator:
Region Zealand
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date  ICMJE September 1, 2017
First Posted Date  ICMJE September 12, 2017
Last Update Posted Date February 25, 2021
Actual Study Start Date  ICMJE August 1, 2017
Actual Primary Completion Date April 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
6 Minutes Walk Distance (6MWD) [ Time Frame: 12 weeks (+/- 2 weeks) ]
Meters
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
  • 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 ]
    Registered continuously during intervention period (excel sheet)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Singing Training for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title  ICMJE The Effects of Singing Training for Patients With Chronic Obstructive Pulmonary Disease (COPD)
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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • 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.

  • 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.

Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Singing training
  • 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.
    Intervention: Behavioral: Physical Training
Publications * Kaasgaard M, Andersen IC, Rasmussen DB, Hilberg O, Løkke A, Vuust P, Bodtger U. Heterogeneity in Danish lung choirs and their singing leaders: delivery, approach, and experiences: a survey-based study. BMJ Open. 2020 Nov 30;10(11):e041700. doi: 10.1136/bmjopen-2020-041700.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2021)
270
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2017)
220
Actual Study Completion Date  ICMJE April 15, 2019
Actual Primary Completion Date April 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03280355
Other Study ID Numbers  ICMJE AU_Singing
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Aarhus
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Aarhus
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Region Zealand
Investigators  ICMJE
Principal Investigator: Uffe Bodtger, MD PhD Region Zealand
Study Director: Peter Vuust, Professor Aarhus Univeristy
PRS Account University of Aarhus
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP