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）：有氧运动是囊性纤维化 (CF) 患者 8 年生存率的最强相关性；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和通气能力的限制，CF儿童需要由目标心率以外的​​参数调节的运动计划。这项随机临床试验的主要目的是测试为期 6 个月的电话强化自我调节运动 (SRE) 计划对 CF 儿童心肺健康（以峰值摄氧量 [VO2] 衡量）的主要终点的效果，与注意力控制（AC）相比。儿童 OMNI 感知劳累量表将用于调整训练强度。次要目标是 1) 比较各组的其他终点：肺功能 (FEV1)、HRQoL 和其他健康指标； 2) 评估移除电话增强后 SRE 组中峰值摄氧量的维持情况； 3) 通过让 AC 小组在没有电话强化的情况下交叉到 SRE 来评估“现实世界”环境中的干预； 4）探索两组儿童和家长的锻炼经历。来自匹兹堡儿童医院 CF 中心的 50 名受试者将根据峰值摄氧量进行分层，并随机分配到电话强化的自我调节运动 (SRE) 组或注意力对照组。 SRE 组将进行为期 6 个月的每周 3 次的家庭锻炼方案，而 AC 组将接受标准护理。在研究的最初 6 个月内，每周都会通过电话联系两组人员。两组的测量将在基线以及第 2、6、8 和 12 个月时进行。在研究的后 6 个月内，SRE 电话强化组的受试者将被指示继续他们的锻炼计划，但他们不会接受电话强化。 AC 组中的受试者将在没有电话强化的情况下交叉到 SRE。主要分析将测试干预组峰值摄氧量的差异。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运动训练方法可以促进运动的长期维持，为提高 CF 患者的生活质量甚至延长寿命带来巨大希望。