Yoga Outcomes Get Assessed in Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 314
- 试验地点
- 2
- 主要终点
- Respiratory Health- related quality of life - measured by the respiratory domain of the Cystic Fibrosis Questionnaire - Revised.
研究概览
简要总结
The goal of this clinical trial is to investigate the effects of yoga participation for adults with cystic fibrosis.
The main question it aims to answer is: does participation in yoga affect health-related quality of life for adults with cystic fibrosis?
Researchers will compare a group completing a 12-week yoga programme alongside usual cystic fibrosis care, to a group completing usual care alone to see if the addition of yoga effects health-related quality of life.
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
- None
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 CF (confirmed by standard criteria; (Farrell et al. 2017))
- •Sixteen years of age or over
- •Home internet access
- •Ability to complete questionnaires in English
- •Stable CF disease as judged by the investigator, a senior CF clinician
排除标准
- •Inability to consent for treatment or measurement
- •Current participation in another interventional study of a medicinal product
- •Current haemoptysis (greater than streaking in the sputum)
- •Known pregnancy at time of recruitment
- •Forced expiratory volume in 1 second (FEV1) below 30% predicted at baseline
- •Use of ambulatory oxygen therapy, long-term oxygen therapy (LTOT) or non-invasive ventilation
- •Current regular participation in yoga practice
- •Current neurological or musculoskeletal injury which would prevent completion of yoga
- •Diagnosis of osteoporosis (bone density Z score <-2.5) or history of spontaneous spinal fractures
- •Uncontrolled gastroesophageal reflux
- •Acute pulmonary exacerbation within 28 days of screening
结局指标
主要结局
Respiratory Health- related quality of life - measured by the respiratory domain of the Cystic Fibrosis Questionnaire - Revised.
时间窗: Baseline, 12 and 24-weeks
Cystic Fibrosis Questionnaire - Revised (CFQ-R) respiratory domain.Scores range from 0 to 100, with higher scores indicating better health.
次要结局
- Other Health-related quality of life domains - captured on the Cystic Fibrosis Questionnaire - Revised (CFQ-R)(Baseline, 12 and 24-weeks)
- Forced Expiratory Volume in 1 second(Baseline, 12 and 24-weeks)
- Forced vital capacity (FVC)(Baseline, 12 and 24-weeks)
- One Minute Sit to Stand Test(Baseline, 12 and 24-weeks)