Effects of Innovative Aerobic Exercise Training in Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Aerobic Exercise Capacity - V02max
研究概览
简要总结
The main objective of this study is to compare the effectiveness of two different exercise interventions in a patient-centered, home-based exercise program for improving cardiorespiratory-fitness in people with cystic fibrosis (CF). We hypothesize cystic fibrosis patients participating in a high intensity interval training (HIIT) group will experience greater improvements in cardiorespiratory-fitness than those in a moderate continuous training (MCT) group. Further, we plan to investigate the efficacy of the comparators on patient-centered outcomes.
详细描述
This study is a randomized control trial that compares MCT to HIIT using a patient-centered and home-based delivery model with CF Care Centers in the United States. Participants will be randomly allocated to either an MCT or HIIT arm. Both the MCT and HIIT interventions are accepted forms of prescribed exercise in clinical practice. The interventions will be delivered with a telehealth platform using internet (HIPAA-Compliant video), phone, and email/text support. All study sites will receive initial and on-going training and program facilitation to assure consistency of delivering the intervention. All participants across both arms visit their respective CF clinics on a regular basis for routine CF care. Thus, our research team will be able to coordinate all testing/assessment visits, including long-term (18-month timepoint), with participants throughout the study. The primary and secondary outcomes include important patient-centered outcomes as selected by our study's CF Patient and Stakeholder Advisory Board.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with Cystic Fibrosis
- •Prescribed and taking for 28 days ivacaftor-tezacaftor-elexacaftor (Trikafta)
- •18 years and older
排除标准
- •17 years of age or less
- •not eligible for ivacaftor-tezacaftor-elexacaftor (Trikafta)
- •inability to exercise
- •pregnancy
- •status post lung transplantation
- •already participating in more than 150 minutes of aerobic exercise per week
结局指标
主要结局
Aerobic Exercise Capacity - V02max
时间窗: 18 months
anaerobic threshold (V02max) measured via Sub-maximal cardiopulmonary exercise test (CPET)
次要结局
- Pulmonary function testing(18 months)
- Quality of Life measured by Cystic Fibrosis Questionnaire - Revised (CFQ-R)(18 months)
研究者
Dave Burnett
Ph.D., Chair Dept. of Respiratory Care and Diagnostic Science
University of Kansas Medical Center
