Impact of Tai Chi exercise on multiple fracture-related risk factors in post-menopausal osteopenic women: a pilot pragmatic, randomized trial.

BACKGROUND: Tai Chi (TC) is a mind-body exercise that shows potential as an effective and safe intervention for preventing fall-related fractures in the elderly. Few randomized trials have simultaneously evaluated TC's potential to reduce bone loss and improve fall-predictive balance parameters in osteopenic women. METHODS: In a pragmatic randomized trial, 86 post-menopausal osteopenic women, aged 45-70, were recruited from community clinics. Women were assigned to either nine months of TC training plus usual care (UC) vs. UC alone. Primary outcomes were changes between baseline and nine months of bone mineral density (BMD) of the proximal femur and lumbar spine (dual-energy X-ray absorptiometry) and serum markers of bone resorption and formation. Secondary outcomes included quality of life. In a subsample (n = 16), quiet standing fall-predictive sway parameters and clinical balance tests were also assessed. Both intent-to-treat and per-protocol analyses were employed. RESULTS: For BMD, no intent-to-treat analyses were statistically significant; however, per protocol analyses (i.e., only including TC participants who completed ≥ 75% training requirements) of femoral neck BMD changes were significantly different between TC and UC (+0.04 vs. -0.98%; P = 0.05). Changes in bone formation markers and physical domains of quality of life were also more favorable in per protocol TC vs. UC (P = 0.05). Changes in sway parameters were significantly improved by TC vs. UC (average sway velocity, P = 0.027; anterior-posterior sway range, P = 0.014). Clinical measures of balance and function showed non-significant trends in favor of TC. CONCLUSIONS: TC training offered through existing community-based programs is a safe, feasible, and promising intervention for reducing multiple fracture risks. Our results affirm the value of a more definitive, longer-term trial of TC for osteopenic women, adequately powered to detect clinically relevant effects of TC on attenuation of BMD loss and reduction of fall risk in this population. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01039012.

Variation in arterial inflow temperature: a regional quality improvement project.

Peer-reviewed evidence (Class IIa, Level B) suggests that arterial blood temperature should be limited to 37 degrees C during cardiopulmonary bypass. We implemented a regional quality improvement initiative to reduce regional variability in our performance around this recommendation at four northern New England medical centers between January 2006 and June 2010. Cardiovascular perfusionists at four medical centers collaborated by conference calls regarding blood temperature management. Evidence from the recommendations were reviewed at each center, and strategies to prevent hyperthermia and to improve performance on this quality measure were discussed. Centers submitted data concerning highest arterial blood temperatures among all isolated coronary artery bypass grafting procedures between 2006 through June 2010. Scope and focus of local practice changes were at the discretion of each center. The timing of each center's quality improvement initiatives was recorded, and adherence to thresholds of 37 degrees C and 37.5 degrees C were analyzed. Data were collected prospectively through our regional perfusion registry. Data were available for 4909 procedures (1645 before interventions, 3264 after interventions). Prior to the quality improvement interventions, 90% of procedures had elevated arterial line temperatures (37 degrees C or more), and afterwards it was 69% (p < .001) for an absolute difference of 21%. Prior to the intervention, 53% of procedures had temperatures beyond a threshold of 37.5 degrees C versus 19% subsequent to interventions, for an absolute difference of 34% (p < .001). This regional effort to reduce patient exposure to elevated arterial line temperatures resulted in a significant sustained reduction in high arterial outflow temperatures at three of the four centers. A regional registry provides a means for assessing performance against evidence-based recommendations, and evaluating short and long-term success of quality improvement initiatives.

Tai Chi for osteopenic women: design and rationale of a pragmatic randomized controlled trial.

BACKGROUND: 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. DISCUSSION: 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. TRIAL REGISTRATION: This trial is registered in ClinicalTrials.gov, with the ID number of NCT01039012.

Increasing research capacity at the New England School of Acupuncture: building grants management infrastructure.

A significant practical, yet perhaps under-appreciated, barrier to a more active role of complementary and alternative medicine (CAM) institutions in research is the organizational infrastructure required for submitting and managing research grants. In this article, we discuss how the New England School of Acupuncture, in collaboration with the Harvard Medical School Osher Institute and with the support of a Developmental Center for Research on Complementary and Alternative Medicine grant awarded by the National Center for Complementary and Alternative Medicine of the National Institutes of Health, developed its grants management infrastructure and increased its research capacity. We highlight initiatives that have been successful, challenges we have encountered, and lessons we learned that may be relevant to other CAM institutions that may wish to develop a research program.