Do Physiotherapy Joint and Muscle Movement (Musculoskeletal) Techniques Improve Posture, Pain, Sputum Clearance, Lung Function or Quality of Life During Admission for a Respiratory Exacerbation in Adults With Cystic Fibrosis?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Thoracic index as measured by the flexicurve (Boyle, Bradley et al. 2008).
研究概览
简要总结
Hypothesis: The addition of a series of musculoskeletal techniques to normal optimal care for the treatment of a respiratory exacerbation in inpatient adults with cystic fibrosis, will lead to further improvements in pain, posture, sputum clearance, lung function and quality of life.
详细描述
Experimental design
A prospective, single blind, randomised control trial.
Methods
50 subjects will be recruited by the admitting physiotherapists from the inpatient wards at Royal Brompton Hospital. Using stratified computer randomisation, the subjects will be allocated to either the control (no treatment group) or the treatment group. The randomisation will be carried out by an independent member of the Department of Cystic Fibrosis and the outcome measures recorded by an observer blind to the randomisation.
Method:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cystic fibrosis (genotype or sweat sodium >70 millimoles per litre or sweat chloride of >60 millimoles per litre)
- •16 years of age or over
- •Inpatient admission for respiratory exacerbation as defined by the Cystic Fibrosis Trust (Cystic Fibrosis Trust Antibiotic Group 2002)
- •Inpatients able to stand for the measurement period without cardiovascular or respiratory compromise.
排除标准
- •Current severe haemoptysis
- •Low bone density (Z score < -3)(World Health Organisation Study Group 1994)
- •Rib fractures
- •Pregnancy
- •Inability to give consent for treatment/ measurement
- •Planned initiation or continuation of treatment in the home environment
- •Current participation in another study.
结局指标
主要结局
Thoracic index as measured by the flexicurve (Boyle, Bradley et al. 2008).
时间窗: Day 0 of admission, Days 5,10 & prior to discharge
次要结局
- Ease of sputum clearance using a 10-centimetre visual analogue scale(Days 0,5,10 & pre discharge)
- Lung function: forced expiratory volume in one second (FEV1), forced vital capacity (FVC)(Days 0,5,10 & pre discharge)
- Pain assessment using a 10-centimetre visual analogue scale(Days 0,5,10 & pre discharge)
- Sputum weight(Days 0,5,10)
- Quality of life - CF-38 questionnaire (Ethics reference number: 98-167)(Days 0 & pre discharge)
- Hospital Anxiety and Depression Scale (Zigmond & Snaith 1983)(Days 0 & pre discharge)