NCT00716664已完成不适用
Pilot Study: Do Physiotherapy Musculoskeletal Techniques Improve Forced Expiratory Volume in One Second in Adults With Cystic Fibrosis?
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Forced expiratory volume in one second
研究概览
简要总结
The pilot study aims to evaluate the effects of a treatment series of gentle joint and muscle movements (in addition to normal optimal care)on lung function, exercise capacity and posture in stable adults with cystic fibrosis.
详细描述
Study type:
Prospective, single-blinded, randomised control trial
Consent
- Prospective subjects will be given written and verbal information about the project and will be given at least 24 hours to consider entry to the study.
- Subjects will give written consent to participate in the project. The top copy will be included in the patient's medical record and a copy placed in the patient's study file.
- A letter will be written to the subject's General Practitioner outlining the purpose of the study and inviting him/her to make contact to discuss the study in more detail if there are any queries or concerns.
- At the time of consent, the appointments for the duration of the interventions and potential follow-up will be made.
Intervention for the treatment group A treatment series of gentle joint and muscle movements (musculoskeletal interventions) will be undertaken by a physiotherapist, weekly, for six weeks. A chaperone would be available if requested by the subject (the patients would be made aware of this when informed about the study.)
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
- Single (Investigator)
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
- •Reported postural changes, stiffness, discomfort and/or pain of musculoskeletal origin in the thoracic spine or chest wall.
- •Diagnosis of cystic fibrosis (confirmed by genotype or a sweat sodium concentration of >70mmol/l or sweat chloride of >60mmol/l)
- •Sixteen years of age or over
- •Patients in a stable clinical state with lung function at the time of entry that is within 10% of the mean of the last two recordings (separated by at least one month).
- •Forced Expiratory Volume in 1 second (FEV1) ≥30% predicted at time of entry to the study.
排除标准
- •Evidence of a current respiratory exacerbation (worsening) as defined by Thornton et al. 2004
- •Cor pulmonale (right heart failure)
- •Low bone density (Z score < -3)(WHO Study Group 1994)
- •Previous history of spontaneous fractures
- •Past history of spinal fracture or other known arthropathic (joint) or spinal disease process
- •Currently undergoing musculoskeletal (physiotherapy, chiropractic or osteopathic) treatment
- •Pregnancy
- •Inability to give consent
- •Current enrollment in another research trial.
结局指标
主要结局
Forced expiratory volume in one second
时间窗: 12 weeks
次要结局
- Forced vital capacity, peak expiratory flow rate(12 weeks)
- Visual analogue scale for pain(12 weeks)
- Modified shuttle test(12 weeks)
- The Cystic Fibrosis Quality of Life Questionnaire, section one: physical functioning(12 weeks)
- Flexi curve measurements of posture(12 weeks)
- Chest wall excursion measurements(12 weeks)
- Full lung function will be measured ≤ one month prior to the start of the study and at the end of the intervention period(12 weeks)
- Questionnaire II - the subject's perspective(12 weeks)
研究者
研究点 (2)
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