The Yoga for Hyperkphosis Trial

瑜伽治疗多发症试验

• 批准号: 6947917
• 负责人: GAIL A GREENDALE
• 金额: $ 47.32万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-09 至 2008-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6947917
• 关键词: alternative medicine; behavioral /social science research tag; body height; clinical research; clinical trials; functional ability; human old age (65+); human subject; human therapy evaluation; longitudinal human study; meditation; musculoskeletal disorder therapy; patient oriented research; physical fitness; psychological aspect of aging; quality of life; respiratory function; spine disorder; therapy compliance

DESCRIPTION (provided by applicant): Hyperkyphosis, excessive curvature of the thoracic spine, is common. It increases with age and is associated with functional limitations and higher mortality. Hyperkyphosis has multiple precipitants, some of which are fixed (e.g., vertebral wedge fractures) and some of which are malleable (e.g., weakness). We demonstrated in a pilot Yoga intervention that women with hyperkyphosis regained height, improved their kyphosis angle, and achieved dramatic physical functional gains [Greendale 2002B]. This proposal intends to take these promising observations to the next step: to test, in a single blind, randomized controlled trial [RCT], whether a specially designed Yoga program can improve hyperkyphosis and its associated functional limitations. The RCT will block randomize (based on "high" and "low" baseline hyperkyphosis) 120 persons aged 60 and over with hyperkyphosis to active treatment, consisting of 6 months of 3-times-per-week Yoga classes, or to a delayed Yoga control group, which will receive 6-months of attention activities followed by Yoga. For each of the primary and secondary outcomes, 6-month change in the Yoga treatment group relative to the control group will be compared. Primary outcomes will be height, kyphometer angle, timed chair stands, functional reach, and timed 8-foot walk. Secondary outcomes will include other kyphosis measures (e.g., flexible ruler), timed physical performance, self-report functional status, quality of life, fear of falling, attitudes toward aging, and pulmonary function. At the end of the 6-month RCT, the control group will be given 6 months of Yoga. Offering delayed Yoga will make recruitment and retention feasible: in the pilot, 100% of volunteers stated that they wanted to do Yoga. A junior Yoga teacher (who assisted the senior teacher during the RCT) will lead the delayed Yoga classes under direct observation by the senior teacher. We will collect study outcomes at the end of the delayed Yoga and will compare the effects in the delayed Yoga group to those observed in the RCT Yoga group. If the effects were similar, this would suggest that the Yoga method could be implemented by other teachers (a requisite for dissemination). While the delayed Yoga is taking place, the RCT Yoga treatment group will continue in a 6-month Yoga maintenance phase. Participants will self-select into a weekly class plus home practice tape use, home tapes only, or no formal program. This phase wilt assess whether participants continue doing Yoga with less intensive supervision and the reasons underlying their selection of maintenance mode. At the end of this phase we will again measure study endpoints to assess whether participants have maintained the physical function achieved at the end of the RCT.

描述（由申请人提供）：过度后凸，胸椎过度弯曲，很常见。它随着年龄的增长而增加，并与功能限制和较高的死亡率有关。过度脊柱后凸有多种沉淀物，其中一些是固定的（例如，椎骨楔形骨折）并且其中一些是可延展的（例如，弱点）。我们在一项试点瑜伽干预中证明，患有过度后凸的女性恢复了身高，改善了后凸角度，并获得了显著的身体功能增益[格林德尔2002 B]。该提案旨在将这些有希望的观察结果带到下一步：在单盲随机对照试验中测试，特别设计的瑜伽计划是否可以改善过度脊柱后凸及其相关的功能限制。随机对照试验将120名60岁及以上的过度后凸患者随机分组（基于“高”和“低”基线过度后凸），进行积极治疗，包括每周3次为期6个月的瑜伽课程，或延迟瑜伽对照组，后者将接受6个月的注意力活动，然后进行瑜伽。对于每个主要和次要结局，将比较瑜伽治疗组相对于对照组的6个月变化。主要结局将是身高、椎体后凸角度、定时椅立、功能性伸展和定时8英尺步行。次要结局将包括其他脊柱后凸测量（例如，柔韧尺）、定时身体表现、自我报告功能状态、生活质量、害怕跌倒、对衰老的态度和肺功能。在6个月的RCT结束时，对照组将接受6个月的瑜伽训练。提供延迟瑜伽将使招募和保留可行：在试点中，100%的志愿者表示他们想做瑜伽。初级瑜伽教师（在RCT期间协助高级教师）将在高级教师的直接观察下领导延迟的瑜伽课程。我们将在延迟瑜伽结束时收集研究结果，并将延迟瑜伽组的效果与RCT瑜伽组中观察到的效果进行比较。如果效果相似，这将表明瑜伽方法可以由其他教师实施（传播的必要条件）。在进行延迟瑜伽的同时，RCT瑜伽治疗组将继续进行为期6个月的瑜伽维持阶段。参与者将自行选择每周一次的课程，加上家庭练习磁带的使用，家庭磁带，或没有正式的计划。这一阶段将评估参与者是否继续做瑜伽与较低强度的监督和背后的原因，他们选择的维护模式。在本阶段结束时，我们将再次测量研究终点，以评估参与者是否保持了RCT结束时达到的身体功能。