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）：后凸畸形（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相关。后凸畸形有多种诱因，其中一些是固定的（例如椎体楔形骨折），一些是可塑的（例如虚弱）。我们在试点瑜伽干预中证明，患有后凸畸形的女性恢复了身高，改善了后凸角度，并取得了显着的身体功能增益 [Greendale 2002B]。该提案旨在将这些有希望的观察结果带入下一步：在单盲、随机对照试验 [RCT] 中测试专门设计的瑜伽计划是否可以改善后凸畸形及其相关的功能限制。该随机对照试验将随机分组（根据“高”和“低”基线后凸畸形）120 名 60 岁及以上患有后凸畸形的患者进行积极治疗，包括为期 6 个月的每周 3 次瑜伽课程，或延迟瑜伽对照组将接受为期 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果，将比较瑜伽治疗组相对于对照组的 6 个月变化。主要结果是身高、跑步计角度、计时椅站立、功能范围和计时 8 英尺步行。次要结果将包括其他驼背测量（例如，灵活的尺子）、定时身体表现、自我报告的功能状态、生活质量、对跌倒的恐惧、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。提供延迟瑜伽将使招募和保留变得可行：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主持延迟的瑜伽课程。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 瑜伽组观察到的效果进行比较。如果效果相似，则表明瑜伽方法可以由其他老师实施（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。参与者将自行选择参加每周课程加家庭练习磁带使用、仅家庭磁带或没有正式课程。此阶段将评估参与者是否在较少的监督下继续练习瑜伽，以及他们选择维持模式的原因。在此阶段结束时，我们将再次测量研究终点，以评估参与者是否保持了 RCT 结束时实现的身体功能。