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Chronic Obstructive Pulmonary DiseaseNCT03280355

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

A study testing Singing training and Physical Training in people with Chronic Obstructive Pulmonary Disease, run by University of Aarhus at 11 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Singing training and Physical Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
11 sitesDenmark
Study dates
1 Aug 2017to 15 Apr 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with a clinical diagnosis of COPD and who meet the following criteria are eligible:
  • Recommended for Pulmonary Rehabilitation and minimum mMRC2 level of dyspnea
  • Motivated for participating in the project (and acceptance of randomization)
  • Sufficient mobility to attend PR

Who cannot join

  • Certain comorbidities (e.g. unstable coronary complications)
  • Severe cognitive disabilities (e.g. dementia)
  • Inability to speak or understand Danish
  • No previous singing experience or musical competence is required.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Denmark11 sites
  • Rudersdal Health Centre

    Birkerød, 3460

  • Helsingor Health Centre

    Elsinore, 3000

  • Fakse Health Centre

    Fakse, 4640

  • Vesthimmerland Health Centre

    Farsø, 9640

  • Hedensted Health Centre

    Hedensted, 8722

  • Ikast-Brande Health Centre

    Ikast, 7430

  • Lemvig Health Centre

    Lemvig, 7620

  • Lolland Health Centre

    Maribo, 4930

  • Silkeborg Health Centre

    Silkeborg, 8600

  • Slagelse Health Centre

    Slagelse, 4200

  • Vordingborg Health Centre

    Vordingborg, 4760

Other trials in Denmark

About this study

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.

Read the 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.

Being tested
Singing training, Physical Training
Keywords
COPD, Chronic Obstructive Pulmonary Disease, Randomised controlled trial (RCT), Rehabilitation, Singing Training
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Singing trainingBehavioural

    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.

  • Physical TrainingBehavioural

    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 groups in NCT03280355
Study groupRoleWhat they receive
Singing TrainingExperimentalSinging Training as training activity in Pulmonary Rehabilitation: 10 weeks, twice a week for 1 1/2 hour, leading to a total of 20 sessions.
Receives: Behavioral: Singing training
Physical TrainingActive comparatorPhysical Training as training activity in Pulmonary Rehabilitation: 10 weeks, twice a week for 1 1/2 hour, leading to a total of 20 sessions.
Receives: Behavioral: Physical Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6 Minutes Walk Distance (6MWD)

    Meters

    Measured: 12 weeks (+/- 2 weeks)

Secondary outcomes (7)
  1. Pedometer

    Number of steps (worn for 1 week (7 days) at baseline and post intervention)

    Measured: 12 weeks (+/- 2 weeks)

  2. St. George's Respiratory Questionnaire (SGRQ)

    Quality of Life-questionnaire (self-reported)

    Measured: 12 weeks (+/- 2 weeks)

  3. Forced Expiratory Volume Predicted (FEV1%)

    The FEV1% is the FEV1 divided by the FVC (Forced Vital Capacity) times 100: FEV1%=FEV1/VC X100

    Measured: 12 weeks (+/- 2 weeks)

  4. Breath Hold Test

    Number of seconds (from max inspiration)

    Measured: 12 weeks (+/- 2 weeks)

  5. Single-breath Count

    Numbers counted (beats per minute=60) (from max inspiration)

    Measured: 12 weeks (+/- 2 weeks)

  6. Compliance

    Self-produced excel sheet with registration each time of each participant's attendance or absence (with or without cause). Registered continuously during intervention period.

    Measured: 10 weeks

  7. Musical Ear Test (MET)

    Test for musical competence: 104 trials on which participants judge whether two short musical phrases (melody/rhythm) are identical or not

    Measured: 12 weeks (+/- 2 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2017
  2. Study start1 Aug 2017
  3. Primary completion15 Apr 2019
  4. Study completion15 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Non-pharmacological, intervention based, group randomised (cluster randomised) controlled trial, 2 arms (intervention and active control group)
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03280355
Sponsor's protocol ID
AU_Singing
Status last verified
Apr 2019
First submitted
1 Sep 2017
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kaasgaard M, Rasmussen DB, Andreasson KH, Hilberg O, Lokke A, Vuust P, Bodtger U. Use of Singing for Lung Health as an alternative training modality within pulmonary rehabilitation for COPD: a randomised controlled trial. Eur Respir J. 2022 May 19;59(5):2101142. doi: 10.1183/13993003.01142-2021. Print 2022 May.

    PubMed 34625480
  • Kaasgaard M, Andersen IC, Rasmussen DB, Hilberg O, Lokke 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.

    PubMed 33257493

Questions about this trial

What is this clinical trial studying?

A study testing Singing training and Physical Training in people with Chronic Obstructive Pulmonary Disease, run by University of Aarhus at 11 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6 Minutes Walk Distance (6MWD) (time frame: 12 weeks (+/- 2 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03280355, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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