The Effects of Singing Training for Patients With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 11
- 主要终点
- 6 Minutes Walk Distance (6MWD)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Assessor (nurse) is masked, primary investigator is masked
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Singing training (Behavioral)
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.
干预措施: Physical Training (Behavioral)
结局指标
主要结局
6 Minutes Walk Distance (6MWD)
时间窗: 12 weeks (+/- 2 weeks)
Meters
次要结局
- Forced Expiratory Volume Predicted (FEV1%)(12 weeks (+/- 2 weeks))
- Pedometer(12 weeks (+/- 2 weeks))
- St. George's Respiratory Questionnaire (SGRQ)(12 weeks (+/- 2 weeks))
- Musical Ear Test (MET)(12 weeks (+/- 2 weeks))
- Breath Hold Test(12 weeks (+/- 2 weeks))
- Compliance(10 weeks)
- Single-breath Count(12 weeks (+/- 2 weeks))