Yoga as a Therapy for Adolescents and Young Adults With Cystic Fibrosis: A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety
研究概览
简要总结
Cystic fibrosis (CF) is a lung disease that affects 30,000 children and adults in the US. Incorporation of regular exercise into the lives of patients with CF is of interest because it may improve lung function and quality of life. Yoga is an activity that may benefit patients with CF in many ways including strengthening muscles of breathing, improving lung function, and reducing stress which could improve quality of life and adherence to therapies. Yoga has been shown to be beneficial in patients with other lung diseases such as asthma, but has not yet been studied in CF.
The investigators hypothesize that yoga will be an activity that is safe and tolerable for CF patients 12 to 25 years of age. The primary aim is to investigate the safety and tolerability of an 8 week yoga program for patients with CF. The secondary aim is to determine the effect of yoga on many aspects of CF disease including respiratory symptoms, adherence to regular CF therapies, quality of life, lung function, exercise tolerance, and nutritional status.
The long-term goal is to use the data obtained in this study to design a future study of the efficacy of yoga in a larger population of CF patients at multiple CF centers. This research has the potential to influence the prevention and treatment of CF by providing data which could be used to help understand the most appropriate and beneficial type of physical activity for CF patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •o Diagnosis of CF by: Sweat chloride ≥60meq/L on two occasions or CFTR genotype with two CF disease-causing mutations and one or more phenotypic features of CF
- •Age ≥12 and ≤25 years
- •FEV1 ≥40 % predicted at screening visit
- •Informed consent and assent
排除标准
- •Wheezing on auscultation of the chest at the enrollment visit
- •Oxygen saturation < 90 % at the enrollment visit
- •Initiation of treatment with oral, inhaled or intravenous antibiotics for an acute respiratory infection in the 2 weeks preceding the enrollment visit
- •Pregnancy
- •History of lung transplant
- •Practiced yoga regularly (≥1 time per week) in the month prior to enrollment
- •Current enrollment in a therapeutic clinical trial
- •Condition or situation which, in the opinion of the investigator, would affect the ability of the patient or family to complete study procedures
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety
时间窗: 16 weeks
Determine if a yoga program is safe for CF patients by monitoring for adverse events throughout the study.
Pain Scores on the Visual Analog Scale as a measure of tolerability
时间窗: 16 weeks
Participants will be given a tolerance questionnaire after each yoga session which will assess their degree of musculoskeletal and chest pain on a visual analog scale. Vital signs will also be measured before and after each yoga session.
次要结局
- Respiratory symptoms(16 weeks)
- Quality of Life(16 weeks)
- Treatment adherence(16 weeks)
- Pulmonary function(16 weeks)
- Ease of breathing(16 weeks)
- BMI(16 weeks)