Singstrong: Singing for Better Lung Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Patient anxiety and depression
研究概览
简要总结
Chronic Obstructive Pulmonary Disease (COPD) is a pervasive, insidious condition associated with catastrophic socioeconomic, healthcare and personal implications. This proposal outlines how a group singing intervention, led by clinical personnel and a community singing leader, can address these challenges. Built upon existing ties between the Principal Investigator (PI) and local COPD support group, this project is co-designed by patients and clinicians. Modelled on similar interventions internationally, this project is pioneering in Ireland. Outputs will include a participant-led symposium and three community COPD choirs, in addition to a number of academic publications. This project is funded by the Irish Research Council (IRC) "New Foundations" scheme.
详细描述
Brief Background:
Approximately 440,000 Irish people suffer from Chronic Obstructive Pulmonary Disease (COPD) (Health Service Executive (HSE), 2018) and it is the fourth most common cause of death, after lung cancer, heart disease and stroke. In addition to many physical issues, patients lack the physical endurance or confidence to participate fully in their lives, leading to isolation, social exclusion and co-morbid depression and anxiety. Addressing the management of people with COPD was highlighted as an urgent priority in the Government's 2017 National Healthcare Quality Reporting System annual report. This application proposes a community-based singing intervention replicating that successfully delivered by the British Lung Foundation (BLF) (https://www.blf.org.uk/support-for-you/singing-for-lung-health). This project is unique in Ireland, and builds on established ties between the (Principal Investigator) PI and the local COPD community. It is supported by COPD Support Ireland.
Study design:
- This study is a pre-post intervention study involving a cohort of COPD patients who are members of regional COPD support groups in Limerick, Ennis and Nenagh.
- Pre-intervention testing will involve self-reported measures wellness using standardised tools as well as a walking test (6-minute walking test (6MWT) and spirometry to asses lung function.
- The intervention is an eight-week singing intervention led by an experienced singing instructor who will be provided with relevant training on singing with lung impairment. Participants will also be provided with a compact disk (CD) for between intervention practice at their own discretion.
- Post-intervention testing will repeat tests done at baseline. Testing will be carried out in both instances by the PI and clinical staff from the geographical area.
Focus groups will be conducted with a sample from each group to support a qualitative evaluation of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None (Participant, Outcomes Assessor)
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 must have an existing diagnosis of COPD according to recognised diagnostic criteria, must be clinically stable, and not have suffered an exacerbation in the 2 weeks prior to testing.
- •All participants must be at least 18 years of age. There is no upper age limit.
- •Participants may be male or female.
- •They must have a good command of written and spoken English.
排除标准
- •Lack of a clinical diagnosis of COPD
- •Presence of physical of psychological co-morbidities precluding participation in either testing or intervention.
研究组 & 干预措施
Group singing and breathing control training
干预措施: Singstrong: (Behavioral)
结局指标
主要结局
Patient anxiety and depression
时间窗: 8 weeks
Hospital Anxiety and Depression Scale (HADS). This questionnaire is widely used to measure anxiety and depression in a general medical population of patients. The questionnaire features seven questions for anxiety and seven for depression of which can be answered within 2 - 5 minutes. Each item is scored from 0-3 with a higher score indicating a greater presence of either anxiety or depression. Maximal (worst) score for either factor is 21.
Functional capacity
时间窗: 8 weeks
Six minute walk test (6MWT). The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. This is measured in metres with levels of oxygen saturation and heart rate pre and post the test also recorded.
Disease impact
时间窗: 8 weeks
COPD Assessment test (CAT). The CAT is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. This is a patient-completed questionnaire assessing all aspects of the impact of COPD (cough, sputum, breathlessness, chest tightness, confidence, activity, sleep and energy levels) There are 8 questions on a 1 to 5 point scale. A higher score indicates more disease impact. Max score is 40.
次要结局
- Lung function(8 weeks)
- Qualitative evaluation of intervention(8 weeks)