PROJECT ALLIFE - EXERCISE AND LEUKEMIA SURVIVORS

Project ALLIFE - 锻炼与白血病幸存者

• 批准号: 6599472
• 负责人: Kevin Charles Oeffinger
• 金额: $ 44.31万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-15 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6599472
• 关键词: behavior therapy; behavioral /social science research tag; body physical activity; cardiovascular disorder prevention; clinical research; disease /disorder proneness /risk; health behavior; human subject; human therapy evaluation; leukemia; lifestyle; long term survivor; outcomes research; pediatric neoplasm /cancer; physical fitness; young adult human (21-34)

DESCRIPTION (provided by applicant): Adult survivors of childhood leukemia are a growing population that have an excess in all-cause and cardiovascular (CVD)-related mortality and are at risk for multiple health problems, including CVD, osteoporosis, and obesity. Physical activity is protective and reduces risk for CVD, hypertension, Type 2 diabetes mellitus, and osteoporosis. The Lifestyle Physical Activity intervention has been efficacious in the general population in increasing sustainable levels of moderate-intensity physical activity and cardiorespiratory fitness and improving cardiovascular risk profiles and mental health. A targeted intervention tailored to the needs of leukemia survivors and intended to increase sustainable levels of moderate-intensity physical activity is not only warranted, but critical. It is imperative that methods to reduce morbidity and mortality of this young population while enhancing quality of life and productivity be addressed. The proposed study, Project ALLIFE (Acute Leukemia Lifestyle Intervention For Everyday), is a 12- month effectiveness trial with 120 young adult survivors of childhood leukemia randomized to either the Lifestyle Physical Activity intervention (ALLIFE-I) or a standard control group who will receive a periodic generic health newsletter (ALLIFE-SC). Major data collections will be at baseline, 6- and 12-months, with the two primary outcomes being levels of physical activity, as measured by 7-day physical activity recall, and cardiorespiratory fitness, as measured by the Aerobic Adaptation Test. Secondary outcomes will include other well-established measures of physical activity, cardiovascular risk profiles, gait and balance assessment, and psychological measurements. The primary research hypothesis to be tested is that the Lifestyle intervention will significantly increase physical activity and cardiorespiratory fitness in adult survivors of childhood leukemia in comparison with standard care. Three additional questions to be addressed are: determining if such an intervention leads to improvement in cardiovascular risk profile; determining if gait and balance disturbances are related to physical inactivity in leukemia survivors and if these disturbances improve with the intervention; and identifying factors that are predictive of improvement or lack of improvement in outcomes. This study will represent the first clinical trial aimed at increasing physical activity in leukemia survivors and will advance our understanding of this vulnerable population.

描述（由申请人提供）：儿童白血病的成年幸存者是一个不断增长的人群，其全因和心血管（CVD）相关死亡率过高，并存在多种健康问题的风险，包括CVD、骨质疏松症和肥胖症。体力活动具有保护作用，可降低心血管疾病、高血压、2型糖尿病和骨质疏松症的风险。生活方式体力活动干预在普通人群中有效，可提高中等强度体力活动和心肺健康的可持续水平，改善心血管风险状况和心理健康。针对白血病幸存者的需求进行有针对性的干预，旨在增加中等强度体力活动的可持续水平，不仅是必要的，而且是至关重要的。必须设法降低这一年轻人口的发病率和死亡率，同时提高生活质量和生产力。拟议的研究项目ALLIFE（急性白血病日常生活方式干预）是一项为期12个月的有效性试验，120名儿童白血病年轻幸存者随机分为生活方式体力活动干预组（ALLIFE-I）或标准对照组，他们将定期收到通用健康通讯（ALLIFE-SC）。主要数据收集将在基线、6个月和12个月时进行，两个主要结局是通过7天体力活动回忆测量的体力活动水平和通过有氧适应测试测量的心肺适应性。次要结局将包括其他已确立的身体活动指标、心血管风险特征、步态和平衡评估以及心理测量。待检验的主要研究假设是，与标准治疗相比，生活方式干预将显著增加儿童白血病成年幸存者的体力活动和心肺功能。需要解决的另外三个问题是：确定这种干预是否会导致心血管风险状况的改善;确定步态和平衡障碍是否与白血病幸存者的身体不活动有关，以及这些障碍是否会随着干预而改善;并确定预测结果改善或缺乏改善的因素。这项研究将代表第一个旨在增加白血病幸存者体力活动的临床试验，并将促进我们对这一弱势群体的理解。