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）：过度金刚病，胸椎过度曲率是常见的。它随着年龄的增长而增加，并且与功能限制和更高的死亡率有关。高温症具有多种沉淀剂，其中一些是固定的（例如椎骨裂缝），其中一些是可延展的（例如，弱点）。我们在试验性瑜伽干预中证明了高温高度的女性恢复了高度，改善了其脑膜角度并获得了巨大的身体功能增长[Greendale 2002b]。该提案旨在将这些有希望的观察结果带到下一步：在一次单一的盲人，随机对照试验[RCT]中测试，是否可以改善过度高管及其相关的功能限制。 RCT将阻止随机化（基于“高”和“低”基线高温），有120名60岁及60岁以上的人进行过度治疗，由6个月的每周瑜伽课6个月组成，或者是延迟的瑜伽控制组，这将获得6个月的注意活动，随后接受瑜伽活动。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。主要结果将是高度，kyphometer角度，定时椅子支架，功能覆盖范围和定时的8英尺步行。次要结果将包括其他尾刺措施（例如灵活的统治者），定时的身体表现，自我报告功能状况，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，对照组将获得6个月的瑜伽。提供延迟的瑜伽将使招募和保留可行：在飞行员中，100％的志愿者表示他们想做瑜伽。一位初级瑜伽老师（在RCT期间协助高级老师）将领导高级老师的直接观察瑜伽课。我们将在延迟瑜伽结束时收集研究结果，并将延迟瑜伽组的影响与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（这是传播的必要条件）。虽然发生了延迟的瑜伽，但RCT瑜伽治疗组将继续进行6个月的瑜伽维护阶段。参与者将自选为每周的课程，外部练习录像带，仅家庭录像带或不正式程序。该阶段枯萎评估参与者是否继续进行瑜伽，并以较少的监督和选择维护模式的理由进行瑜伽。在此阶段结束时，我们将再次衡量研究终点，以评估参与者是否维护RCT结束时所获得的身体功能。