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临床试验/NCT00609050
NCT00609050已完成不适用

Self-Regulated Exercise in CF: A Randomized Trial

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2007年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
Cardiopulmonary Fitness: Peak VO2

研究概览

简要总结

The aim of this study is to test the effect of a 6-month program of self-regulated, home-based exercise with telephone reinforcement on the cardiorespiratory fitness, pulmonary function and health-related quality of life of children with cystic fibrosis (CF), compared to controls. Exploring the exercise experiences of the children and parents is a secondary aim.

详细描述

CF is a life-long illness that requires complex and dynamic adjustment by the patient and family. The nursing role is vital to the multidisciplinary team approach required in providing comprehensive, individualized care for these patients. Nurses facilitate the coordination of health care efforts and support the patient and family across physical and psychosocial domains. With the well-documented correlation between exercise tolerance and both survival and HRQoL, exercise represents a critical treatment focus for CF patients. Nurses contribute to standard exercise rehabilitation programs, through education, psychosocial support, and communication. In this exercise training study, the nursing role will include: a) teaching the patients and families how to use the OMNI scale, b) confirming that they understand the home-based exercise regimen, and c) ensuring that the home-care program is properly followed by placing weekly telephone calls to assess progress and barriers. Long-term nursing application will occur via dissemination of the OMNI training manual, to be developed as part of this study, for use by CF nurses in clinics worldwide.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • CF diagnosis
  • age 10-18 years
  • reliable pulmonary function tests
  • living at home
  • able to read
  • able to ride a stationary bike
  • able to walk and/or run on a treadmill.

排除标准

  • Enrolled in another intervention study
  • in structured aerobic activity for 30 continuous minutes 3 times per week
  • sibling enrolled in study.

结局指标

主要结局

Cardiopulmonary Fitness: Peak VO2

时间窗: 1 year

次要结局

  • Pulmonary function: FEV1 and sustained phonation time(1 year)
  • Health-related quality of life: Quality of well-being scale and cystic fibrosis questionnaire(1 Year)
  • Exercise experiences of children and parents: Interviews(1 Year)
  • Cardiopulmonary fitness: VO2150 and peak power output(1 year)

研究者

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

David Orenstein

Professor of Pediatrics

University of Pittsburgh

研究点 (2)

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