The Yoga for Hyperkphosis Trial

描述（由申请人提供）：后凸过度，胸椎过度弯曲，是常见的。它随着年龄的增长而增加，并与功能限制和更高的死亡率有关。后凸过度有多种诱发因素，其中一些是固定的（如椎体楔形骨折），另一些是可延展性的（如虚弱）。我们在一项瑜伽干预试验中证明，患有后凸过度的女性可以恢复身高，改善后凸角度，并显著提高身体功能[Greendale 2002B]。本研究旨在将这些有希望的观察结果带入下一步：通过一项单盲随机对照试验[RCT]来测试一个特别设计的瑜伽项目是否可以改善后凸症及其相关的功能限制。该随机对照试验将随机分组（基于“高”和“低”基线后凸过度）120名60岁及以上的后凸过度患者进行积极治疗，包括6个月每周三次的瑜伽课程，或延迟瑜伽对照组，后者将接受6个月的注意力活动，然后是瑜伽。对于每个主要和次要结果，将比较瑜伽治疗组相对于对照组6个月的变化。主要指标包括身高、后臀角、椅子站立时间、功能延伸和8英尺步行时间。次要结果将包括其他后凸测量（例如，灵活尺子）、定时身体表现、自我报告的功能状态、生活质量、对摔倒的恐惧、对衰老的态度和肺功能。在6个月的随机对照试验结束时，对照组将进行6个月的瑜伽训练。提供延迟瑜伽将使招聘和保留变得可行：在试点中，100%的志愿者表示他们想做瑜伽。一名初级瑜伽老师（在RCT期间协助高级老师）将在高级老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随机对照瑜伽组的效果进行比较。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，随机对照试验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的课程加上家庭练习磁带，只有家庭磁带，或没有正式的课程。这一阶段将评估参与者是否在较少的监督下继续做瑜伽，以及他们选择维护模式的原因。在这一阶段结束时，我们将再次测量研究终点，以评估参与者是否保持了在RCT结束时达到的身体功能。

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.