Effects of a Partially Supervised Conditioning Program in CF: an International Multi-centre, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 28
- 主要终点
- Change in forced expiratory volume in 1 second (FEV1; in % predicted using the average of two baseline measurements) from baseline to 6 months in the intervention group compared to controls.
研究概览
简要总结
Physical activity and exercise have become an accepted and valued component of Cystic Fibrosis care. Regular physical activity and exercise can slow the rate of decline of pulmonary function, improve physical fitness, and enhance quality of life. However, motivating people to be more active is challenging. Supervised exercise programs are expensive and labor intensive, and adherence falls off significantly once supervision ends. Unsupervised or partially supervised programs are less costly and more flexible, but compliance can be more problematic. The primary objective of this study is to evaluate the effects of a 12-months partially supervised exercise intervention along with regular motivation on forced expiratory volume in 1 second (FEV1) in a large international group of cystic fibrosis patients. Secondary endpoints include patient reported quality of life, as well as levels of anxiety and depression, and control of blood sugar. A total of 292 patients with cystic fibrosis 12 years and older with a FEV1 ≥35% predicted will be recruited. Following baseline assessments (2 visits) patients will be randomized into an intervention and a control group. Thereafter, they will be seen every 3 months for assessments in their centre for one year (4 follow-up visits). Along with individual counseling to increase vigorous physical activity by at least 3 hours per week on each clinic visit, the intervention group will document daily exercise and inactivity time and will receive a step counter and they will record their progress with a web-based program. They will also receive monthly phone calls from the study staff. After 6 months, they will continue with the step counter and web-based program for a further 6 months. The control group will receive access to this intervention after 12 months of standardized care. Should this relatively simple program prove successful, this will be made available on a wider scale internationally.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Cystic Fibrosis
- •Age ≥12 years
- •Forced expiratory volume in 1 second (FEV1) ≥ 35% predicted
- •Access to the internet
排除标准
- •Participation in another clinical trial up to 4 weeks prior to the first baseline visit
- •Pregnancy/Breastfeeding
- •Inability to exercise
- •More than 4 hours of reported strenuous physical activities per week currently or up to 3 months prior to baseline measurements and not already planned within the coming 6 months.
- •Unstable condition precluding exercise (major hemoptysis or pneumothorax within the last 3 months, acute exacerbation and iv-antibiotics during the last 4 weeks, planned surgery, listed for lung transplantation, major musculoskeletal injuries such as fractures or sprains during the last 2 months, others according to the impression of the doctor)
- •Cardiac arrhythmias with exercise
- •Requiring additional oxygen with exercise
- •Recent diagnosis of diabetes 3 months prior to screening or at screening
- •Recent changes in medication 1 month or less prior to screening (systemic steroids, ibuprofen, inhaled antibiotics, mannitol, DNAse, hypertonic saline)
- •At least one G551D mutation and not on ivacaftor (VX770) yet but planned start or planned stop of ivacaftor during the trial
- •Colonization with Burkholderia cenocepacia
研究组 & 干预措施
Control
Keep activity level constant
Exercise Intervention
Add three hours of intense physical activities per week to baseline activities. Weekly exercise should include at least 30 minutes of strength building activities and at least two hours of aerobic activities. Exercise bouts lasting 20 min or longer will be counted with respect to total weekly training time.
干预措施: Exercise Intervention (Behavioral)
结局指标
主要结局
Change in forced expiratory volume in 1 second (FEV1; in % predicted using the average of two baseline measurements) from baseline to 6 months in the intervention group compared to controls.
时间窗: baseline and 6 months
次要结局
- Change in measured steps per day(baseline to 6 months and baseline to 12 months)
- Change in exercise steps per day(baseline to 6 months and baseline to 12 months)
- Days on additional oral / intravenous antibiotics(baseline to 6 months and baseline to 12 months)
- Change in percent body fat(baseline to 6 months and baseline to 12 months)
- Change in depression, anxiety and stress scores(baseline to 6 months and baseline to 12 months)
- Serious adverse events(baseline to 6 months and baseline to 12 months)
- Change in reported physical activity(baseline to 6 months and baseline to 12 months)
- Change in forced vital capacity (FVC; % predicted)(baseline to 6 months and baseline to 12 months)
- Change in body mass index (kg/m2)(baseline to 6 months and baseline to 12 months)
- Change in muscle mass (kg)(baseline to 6 months and baseline to 12 months)
- Change in plasma glucose concentrations 1 and 2 hours after a standardized glucose load(baseline to 9 months)
- Change in peak oxygen uptake (%predicted)(baseline to 6 months and baseline to 12 months)
- Change in maximal aerobic power (%predicted)(baseline to 6 months and baseline to 12 months)
- Change in residual volume in percent of total lung capacity (RV/TLC; %)(baseline to 6 months and baseline to 12 months)
- Time to first exacerbation(baseline to 6 months and baseline to 12 months)
- Adverse events possibly or likely related to exercise(baseline to 6 months and baseline to 12 months)
- Change in forced expiratory volume in 1 second (FEV1; %predicted)(baseline to 6 months and baseline to 12 months)
- Number of upper respiratory tract infections(baseline to 6 months and baseline to 12 months)
- Severe adverse events(baseline to 6 months and baseline to 12 months)
- Change in Quality of Life scales(baseline to 6 months and baseline to 12 months)
研究者
Prof. Helge Hebestreit
Professor Dr. med.
Wuerzburg University Hospital