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临床试验/NCT02277860
NCT02277860已完成不适用

Gaming Console Home-Based Exercise for Adults With Cystic Fibrosis

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2015年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
Peak oxygen consumption (VO2 peak)

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, facility-based exercise programs are expensive and labor intensive (since groups of patients with CF cannot exercise together in the same physical location). Home-based exercise using an interactive exergame device may be an effective way to improve adherence to an exercise program for patients with CF. Therefore, the primary objective of this study is to evaluate the effects of a 12-week, home-based exergame exercise intervention on aerobic capacity (peak VO2). The secondary endpoint is nasal potential difference, an indicator of how well sodium and chloride flow across the mucous membranes in the nose. Other outcomes include patient-reported quality of life and habitual physical activity level. Following baseline assessments participants will be begin a 12 week, partially-supervised exercise program consisting of at least 90 minutes per week of aerobic and resistance exercise training using the Nintendo Wii Fit Plus exergaming device. Participants will receive at least monthly follow-up phone calls to provide additional exercise counseling and motivation. After 12 weeks, they will continue with the exergame intervention for another 12 weeks, but without external supervision.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • confirmed diagnosis of CF
  • currently sedentary (<60 min/week of physical activity)
  • stable clinical condition (no exacerbation in last 6 weeks)

排除标准

  • nasal surgery for polyposis in the past 2 years
  • participating or have participated (in the past 30 days) in another clinical trial which can affect the outcomes of the proposed study
  • unable to read/speak English
  • recurrent pneumothorax (in the past 6 months)
  • hemoptysis (hospitalized in the past 6 months)
  • uncontrolled CF-related diabetes (HbA1c > 10%)

研究组 & 干预措施

Exercise

Experimental

Aerobic and strength training using the Wii Fit Plus for ≥ 30 min, ≥3 days/week, for 12 weeks, at a moderate intensity (Borg CR10 3-5).

干预措施: Exercise (Behavioral)

结局指标

主要结局

Peak oxygen consumption (VO2 peak)

时间窗: 12 and 24 weeks

Measure of aerobic physical fitness

次要结局

  • Nasal potential difference (NPD)(12 weeks)
  • Cystic Fibrosis Questionnaire-Revised (CFQ-R))(12 and 24 weeks)
  • Habitual physical activity level(12 and 24 weeks)

研究者

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

John D Lowman, PT, PhD

Assistant Professor

University of Alabama at Birmingham

研究点 (2)

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