Self-Regulated Exercise in CF: A Randomized Trial

CF 中的自我调节运动：随机试验

基本信息

批准号：
7759162
负责人：
DAVID M ORENSTEIN
金额：
$ 42.79万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-03-01 至 2011-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7759162
关键词：
Abbreviations Address Aerobic Age Area Attention Behavior Birth Blood Carbon Dioxide Caucasians Caucasoid Race Cessation of life Child Chronic Disease Clinical Control Groups Cystic Fibrosis Deterioration Diagnosis Disease Educational Status Energy Metabolism Excision Exercise Exertion Forced expiratory volume function Foundations Future Genetic Crossing Over Goals Health Heart Rate Home environment Human Intervention Learning Length Life Maintenance Measurement Measures Medical Modeling Muscle Contraction Output Oxygen Oxygen Consumption Parents Partial Pressure Participant Pediatric Hospitals Personal Satisfaction Phonation Physical activity Psychological reinforcement Pulmonary Function Test/Forced Expiratory Volume 1 Pulmonary function tests Quality of life Questionnaires Randomized Randomized Clinical Trials Regimen Regulation Research Research Personnel Science Study Subject Surveys Techniques Technology Telephone Testing Time Training Vital capacity Work analog base children with cystic fibrosis cystic fibrosis patients experience fitness group intervention health related quality of life improved innovation meetings post intervention programs pulmonary function randomized trial standard care uptake

项目摘要

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.

有氧运动是囊性纤维化 (CF) 患者 8 年生存率的最强相关因素；锻炼事实证明，训练可以改善这些儿童的健康状况。由于临床状态的波动和由于通气能力有限，CF 儿童需要由其他参数调节的锻炼计划超过目标心率。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，主要终点为电话强化 CF 儿童的心肺健康（以峰值摄氧量 [VO2] 衡量）注意力控制（AC）。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 SRE 组中峰值摄氧量的维持情况拆除电话加固后； 3）评估“现实世界”环境中的干预 AC 组交叉到 SRE，无需电话增援； 4）探索锻炼经验两组的儿童和家长。来自匹兹堡儿童医院 CF 中心的 50 名受试者将按峰值摄氧量分层，并随机分配至电话自我调节锻炼 (SRE) 强化组或注意力控制组。 SRE 小组将每周进行 3 次在家活动 AC组将接受为期6个月的锻炼方案，而AC组将接受标准护理。我们将联系这两个团体在研究的最初 6 个月内每周通过电话。两组的测量将在基线以及 2、6、8 和 12 个月。在研究的后 6 个月中，SRE 中的受试者电话强化小组将被指示继续他们的锻炼计划，但他们不会收到电话加固。 AC组中的受试者将在没有电话的情况下交叉到SRE 加强。主要分析将测试干预组峰值摄氧量的差异。相似的将使用以下方法对主要次要终点 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运动训练方法可能会促进长期维持锻炼，有望提高质量，也许甚至CF患者的生命长度。

项目成果

期刊论文数量（2）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Exercise intensity self-regulation using the OMNI scale in children with cystic fibrosis.

使用 OMNI 量表对囊性纤维化儿童进行运动强度自我调节。

DOI：
发表时间：
2013-05
期刊：
影响因子：
3.1
作者：
Higgins, Linda W;Robertson, Robert J;Kelsey, Sheryl F;Olson, Marian B;Hoffman, Leslie A;Rebovich, Paul J;Haile, Luke;Orenstein, David M
通讯作者：
Orenstein, David M

Parent and child perceptions of a self-regulated, home-based exercise program for children with cystic fibrosis.

家长和孩子对针对囊性纤维化儿童的自我调节、家庭锻炼计划的看法。

DOI：
发表时间：
2013-09
期刊：
影响因子：
2.5
作者：
Happ, Mary Beth;Hoffman, Leslie A;Higgins, Linda W;Divirgilio, Dana;DiVirgilio, Dana;Orenstein, David M
通讯作者：
Orenstein, David M