Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03280355 |
| Other study ID # |
AU_Singing |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2017 |
| Est. completion date |
April 15, 2019 |
Study information
| Verified date |
April 2019 |
| Source |
University of Aarhus |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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.
