Self-Regulated Exercise in CF: A Randomized Trial

描述（由申请人提供）：有氧适能与囊性纤维化（CF）患者的8年生存率最强相关；运动训练已被证明可以改善这些孩子的健康状况。由于临床状态的波动和通气能力的限制，CF患儿需要由目标心率以外的参数调节的运动计划。本随机临床试验的主要目的是测试与注意控制（AC）相比，为期6个月的自我调节运动（SRE）和电话强化计划对CF儿童心肺健康（以峰值摄氧量[VO2]测量）的主要终点的影响。使用儿童感知运动强度OMNI量表对训练强度进行调整。次要目的是：1)比较各组的其他终点：肺功能（FEV1）、HRQoL和其他健康指标；2)评价去除电话加固后SRE组VO2峰值的维持情况；3)在“真实世界”环境中，通过让交流小组在没有电话强化的情况下过渡到SRE来评估干预；4)探讨两组儿童及家长的运动体验。来自匹兹堡儿童医院CF中心的50名受试者将根据VO2峰值进行分层，随机分配到带有电话强化的自我调节练习（SRE）组和注意对照组。SRE组将进行为期6个月的每周3次的家庭锻炼方案，而AC组将接受标准治疗。在研究的前6个月，两组受试者每周都将通过电话联系。两组的测量将在基线和2、6、8和12个月进行。在研究的第二个6个月，SRE加电话强化组的受试者将被指导继续他们的锻炼计划，但他们将不接受电话强化。AC组的受试者将在没有电话强化的情况下切换到SRE。初步分析将测试干预组VO2峰值的差异。将使用纵向重复测量模型对主要次要终点FEV1和HRQoL评分进行类似的分析。这种创新的自我调节的运动训练方法可能会促进运动的长期维持，对提高CF患者的生活质量甚至延长生命有很大的希望。

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.