Singing for Health: Improving Experiences of Lung Disease (SHIELD Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from Baseline in Short Form 36 tool (SF-36)
研究概览
简要总结
A randomised clinical trial to assess the impact of group singing on health for people with chronic obstructive pulmonary disease (COPD).
详细描述
Singing for lung health (SLH) is a novel approach intended to improve the health status of people with respiratory disease. In group sessions, a trained singing leader teaches vocal techniques, which improve breathing control and posture, in the context of an enjoyable non-disease related activity. Initial pilot studies and qualitative work have established the concept that SLH can produce physical, psychological and social benefits. A properly conducted efficacy study is needed before larger scale trials, addressing impacts over a longer term and effect on health resource utilisation, can be undertaken.
DESIGN: An assessor blind, parallel group, randomised controlled trial, to assess the effects of SLH compared to usual care on health status. The investigator will also evaluate the impact on physical activity, physical performance, and breathlessness perception to investigate the mechanisms involved.
Research question and outcome measures:
The primary outcome will be change in health status, assessed using the Short Form 36 tool (SF-36), comparing SLH and control arms.
Additional endpoints will be: the COPD assessment test score (CAT), the MRC dyspnoea score, Dyspnoea-12, Activities-specific Balance Confidence scale (ABC scale).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Masking of participants not possible due to the nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with stable COPD
排除标准
- •Pulmonary rehabilitation less than 4 months ago
- •Unable to take part in singing sessions due to comorbidity (e.g. life limiting illness, cognitive impairment)
- •Previous participation in SLH classes
结局指标
主要结局
Change from Baseline in Short Form 36 tool (SF-36)
时间窗: At baseline, then repeated after 12 weeks.
A well-established, supervised, self-completion health status questionnaire. This consists of eight sections for which a score of 0 to 100 is created, with 0 being maximum disability and 100 equivalent to no disability.
次要结局
- Changes in PROactive physical activity in COPD tool (cPPAC)(At baseline, then repeated after 12 weeks.)
- Changes in Short Physical Performance Battery (SPPB)(At baseline, then repeated after 12 weeks.)
- Changes in Generalised Anxiety Disorder Assessment (GAD-7)(At baseline, then repeated after 12 weeks.)
- Changes in Six-minute walk test(At baseline, then repeated after 12 weeks.)
- Changes in COPD assessment test (CAT)(At baseline, then repeated after 12 weeks.)
- Changes in Patient Health Questionnaire 9 (PHQ-9)(At baseline, then repeated after 12 weeks.)
- Changes in Dyspnoea-12 questionnaire(At baseline, then repeated after 12 weeks.)
- Changes in Activities-specific Balance Confidence scale(At baseline, then repeated after 12 weeks.)