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临床试验/NCT04543929
NCT04543929已完成不适用

Effects of Innovative Aerobic Exercise Training in Cystic Fibrosis

University of Kansas Medical Center2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2020年2月11日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dave Burnett

Ph.D., Chair Dept. of Respiratory Care and Diagnostic Science

University of Kansas Medical Center

研究点 (2)

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