Self-Regulated Exercise in CF: A Randomized Trial

有氧健身是囊性纤维化患者8年生存率的最强相关性；运动 训练已被证明能改善这些儿童的健康状况。由于临床状态的波动和 呼吸机容量的限制，患有CF的儿童需要由其他参数调节的运动计划 而不是目标心率。这项随机临床试验的主要目的是测试6个月的疗效。 自我调节锻炼(SRE)计划，在主要终点电话强化 CF儿童的心肺适合度(以最大摄氧量[VO2]衡量)，与 注意控制(AC)。将使用儿童全方位体力量表进行调整 训练强度。次要目标是1)比较两组在其他终点：肺功能 (FEV1)、HRQOL和其他体能测量；2)评估SRE组峰值VO2的维持情况 在移除电话加固件之后；3)通过以下方式评估干预措施的“真实世界”设置 AC组在没有电话增援的情况下交叉到SRE；4)探索运动经验 两组中的儿童和父母。来自匹兹堡儿童医院CF中心的50名受试者 将根据最高VO2进行分层，并随机分配到电话自我调节锻炼(SRE) 强化组或注意对照组。SRE小组将在家中进行每周3次的 运动方案为6个月，而AC组将接受标准护理。将与这两个群体联系 在研究的最初6个月期间，每周通过电话。两组的测量都将在 基线和2、6、8和12个月。在研究的后6个月，SRE中的受试者 电话增援小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组的受试者将在没有电话的情况下交叉到SRE 增援。初步分析将检验干预组VO2峰值的差异。类似 将对主要次要终点FEV1和HRQOL分数进行分析，使用 纵向重复测量模型。这种创新的自我调节运动训练方法可能会 提倡长期坚持锻炼，为提高质量大有可为，说不定 甚至CF患者的生命长度。

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.