Self-Regulated Exercise in CF: A Randomized Trial

CF 中的自我调节运动：随机试验

• 批准号: 7211063
• 负责人: DAVID M ORENSTEIN
• 金额: $ 40.87万
• 依托单位: CHILDREN'S HOSP PITTSBURGH/UPMC HLTH SYS
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2010-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7211063
• 关键词: Self; Regulated; Exercise; CF; Randomized

DESCRIPTION (provided by applicant): Aerobic fitness is the strongest correlate of 8-year survival in patients with cystic fibrosis (CF); exercise training has been shown to improve fitness in these children. Because of fluctuations in clinical status and limitations in ventilatory capacity, children with CF need exercise programs regulated by parameters other than target heart rate. The primary aim of this randomized clinical trial is to test the effect of a 6 month program of self-regulated exercise (SRE) with telephone reinforcement on the primary endpoint of cardiorespiratory fitness (measured as peak oxygen uptake [VO2]) of children with CF, compared to attention control (AC). The Children's OMNI Scale of Perceived Exertion will be used to make adjustments in training intensity. The secondary aims are to 1) compare the groups on other endpoints: pulmonary function (FEV1), HRQoL, and additional measures of fitness; 2) evaluate maintenance of peak VO2 in the SRE group after removal of the telephone reinforcement; 3) evaluate the intervention in a "real world" setting by having the AC group cross over to SRE without telephone reinforcement; and 4) explore the exercise experiences of children and parents in both groups. Fifty subjects from the CF Center at Children's Hospital of Pittsburgh will be stratified by peak VO2 and randomly assigned to the self-regulated exercise (SRE) with telephone reinforcement or the attention control group. The SRE group will engage in a 3-times-a-week at-home exercise regimen for 6 months, while the AC group will receive standard care. Both groups will be contacted weekly by telephone during the initial 6 months of the study. Measurements for both groups will occur at baseline and 2, 6, 8, and 12 months. During the second 6 months of the study, the subjects in the SRE with telephone reinforcement group will be instructed to continue their exercise program, but they will not receive telephone reinforcement. The subjects in the AC group will crossover to SRE without telephone reinforcement. The primary analysis will test the difference in peak VO2 by intervention group. Similar analyses will be carried out for the main secondary endpoint, FEV1, and for the HRQoL score, using longitudinal repeated measures models. This innovative self-regulated approach to exercise training may promote long-term maintenance of exercise, holding great promise for improving the quality and perhaps even length of CF patients' lives.

描述（由申请人提供）：有氧健身是囊性纤维化（CF）患者8年生存率的最强相关因素;运动训练已被证明可改善这些儿童的健身。由于临床状态的波动和排便能力的限制，CF儿童需要通过目标心率以外的参数调节运动计划。这项随机临床试验的主要目的是测试与注意力控制（AC）相比，6个月的自我调节运动（SRE）计划与电话强化对CF儿童心肺适能（测量为峰值摄氧量[VO 2]）的主要终点的影响。将使用儿童OMNI感知用力量表来调整训练强度。次要目的是：1）比较两组的其他终点：肺功能（FEV 1）、HRQoL和其他健康指标; 2）评价SRE组在去除电话强化后峰值VO 2的维持情况; 3）通过将AC组交叉至SRE（无电话强化），评价“真实的世界”环境中的干预情况;（4）探讨两组儿童及家长的运动经验。来自匹兹堡儿童医院CF中心的50名受试者将按VO 2峰值分层，并随机分配到自我调节运动（SRE）与电话强化或注意力控制组。SRE组将在6个月内每周进行3次在家锻炼，而AC组将接受标准护理。在研究的最初6个月期间，每周通过电话联系两组。两组的测量将在基线和2、6、8和12个月时进行。在研究的第二个6个月期间，将指导SRE和电话强化组中的受试者继续他们的锻炼计划，但他们将不接受电话强化。AC组受试者将交叉至SRE，无需电话强化。主要分析将按干预组检验峰值VO 2的差异。将使用纵向重复测量模型对主要次要终点FEV 1和HRQoL评分进行类似分析。这种创新的自我调节的运动训练方法可以促进长期的运动维持，为提高CF患者的生活质量甚至寿命带来了巨大的希望。