Self-Regulated Exercise in CF: A Randomized Trial

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 训练已被证明可以改善这些儿童的健康状况。由于临床状态的波动， 在解释能力的限制，CF儿童需要通过其他参数调节的运动计划 目标心率。这项随机临床试验的主要目的是测试6个月的效果， 自我调节运动（SRE）计划与电话强化的主要终点 CF儿童的心肺适应性（以峰值摄氧量[VO2]测量），与 注意力控制（AC）儿童的OMNI感知注意力量表将用于调整 训练强度次要目的是1）比较其他终点的组：肺功能 （FEV1）、HRQoL和其他健康指标; 2）评价SRE组中峰值VO2的维持情况 在移除电话加固之后; 3）通过具有以下内容来评估"真实的世界"设置中的干预： AC组在没有电话强化的情况下进入SRE; 4）探索 两组的孩子和父母。来自匹兹堡儿童医院CF中心的50名受试者 将根据VO2峰值分层，并随机分配到自我调节运动（SRE）， 强化组或注意力控制组。SRE小组将每周在家进行3次 运动方案6个月，而AC组将接受标准护理。两个组织都将被联系 在研究的最初6个月期间，每周通过电话进行一次。两组的测量将在 基线和2、6、8和12个月。在研究的第二个6个月期间，SRE中的受试者 电话强化组将被指示继续他们的锻炼计划，但他们不会收到 电话增援AC组受试者将交叉至SRE，无需电话 加固.主要分析将按干预组检验峰值VO2的差异。类似 将使用以下指标对主要次要终点FEV1和HRQoL评分进行分析 纵向重复测量模型。这种创新的自我调节的运动训练方法可以 促进长期保持锻炼，为提高质量， 甚至缩短CF患者的寿命。

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.