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