Division for Research and Education in Complementary and Integrative Medical Therapies, Harvard Medical School, The Landmark Center, Suite 22-A, Boston, MA 02215, USA.
BMC Musculoskelet Disord. 2010 Mar 1;11:40. doi: 10.1186/1471-2474-11-40.
Post-menopausal osteopenic women are at increased risk for skeletal fractures. Current osteopenia treatment guidelines include exercise, however, optimal exercise regimens for attenuating bone mineral density (BMD) loss, or for addressing other fracture-related risk factors (e.g. poor balance, decreased muscle strength) are not well-defined. Tai Chi is an increasingly popular weight bearing mind-body exercise that has been reported to positively impact BMD dynamics and improve postural control, however, current evidence is inconclusive. This study will determine the effectiveness of Tai Chi in reducing rates of bone turnover in post-menopausal osteopenic women, compared with standard care, and will preliminarily explore biomechanical processes that might inform how Tai Chi impacts BMD and associated fracture risks.
METHODS/DESIGN: A total of 86 post-menopausal women, aged 45-70y, T-score of the hip and/or spine -1.0 and -2.5, have been recruited from primary care clinics of a large healthcare system based in Boston. They have been randomized to a group-based 9-month Tai Chi program plus standard care or to standard care only. A unique aspect of this trial is its pragmatic design, which allows participants randomized to Tai Chi to choose from a pre-screened list of community-based Tai Chi programs. Interviewers masked to participants' treatment group assess outcomes at baseline and 3 and 9 months after randomization. Primary outcomes are serum markers of bone resorption (C-terminal cross linking telopeptide of type I collagen), bone formation (osteocalcin), and BMD of the lumbar spine and proximal femur (dual-energy X-ray absorptiometry). Secondary outcomes include health-related quality-of-life, exercise behavior, and psychological well-being. In addition, kinetic and kinematic characterization of gait, standing, and rising from a chair are assessed in subset of participants (n = 16) to explore the feasibility of modeling skeletal mechanical loads and postural control as mediators of fracture risk.
Results of this study will provide preliminary evidence regarding the value of Tai Chi as an intervention for decreasing fracture risk in osteopenic women. They will also inform the feasibility, value and potential limitations related to the use of pragmatic designs for the study of Tai Chi and related mind-body exercise. If the results are positive, this will help focus future, more in-depth, research on the most promising potential mechanisms of action identified by this study.
This trial is registered in ClinicalTrials.gov, with the ID number of NCT01039012.
绝经后骨质减少的女性骨骼骨折风险增加。目前的骨质减少治疗指南包括运动，但是，对于减轻骨密度（BMD）丧失或解决其他骨折相关风险因素（例如平衡不良、肌肉力量下降）的最佳运动方案尚未明确。太极拳是一种越来越受欢迎的负重身心运动，据报道，它可以积极影响 BMD 动态并改善姿势控制，但目前的证据尚无定论。本研究将确定与标准护理相比，太极拳在降低绝经后骨质减少女性骨转换率方面的有效性，并初步探讨可能解释太极拳如何影响 BMD 和相关骨折风险的生物力学过程。
方法/设计：总共从波士顿一家大型医疗保健系统的初级保健诊所招募了 86 名 45-70 岁的绝经后女性，其髋部和/或脊柱的 T 评分在-1.0 至-2.5 之间。她们被随机分为组基础的 9 个月太极拳计划加标准护理或仅标准护理。该试验的一个独特方面是其实用设计，允许随机分配到太极拳组的参与者从预先筛选的社区太极拳计划列表中进行选择。访视者对参与者的治疗组进行盲法评估，在随机分组后 3 个月和 9 个月评估结果。主要结果是血清骨吸收标志物（I 型胶原 C 端交联肽）、骨形成标志物（骨钙素）和腰椎及股骨近端 BMD（双能 X 射线吸收法）。次要结果包括健康相关生活质量、运动行为和心理幸福感。此外，还评估了一部分参与者（n = 16）的步态、站立和从椅子上起身的运动动力学和运动学特征，以探讨建模骨骼机械负荷和姿势控制作为骨折风险中介的可行性。
本研究的结果将提供关于太极拳作为降低骨质减少女性骨折风险的干预措施的初步证据。它们还将为实用设计在太极拳和相关身心运动研究中的使用提供可行性、价值和潜在局限性方面的信息。如果结果为阳性，这将有助于将未来更深入的研究集中在本研究确定的最有前途的潜在作用机制上。
该试验在 ClinicalTrials.gov 注册，注册号为 NCT01039012。
