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Tai Chi for osteopenic women: design and rationale of a pragmatic randomized controlled trial.
BMC Musculoskelet Disord. 2010 Mar 01; 11:40.BM

Abstract

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.

Authors+Show Affiliations

Division for Research and Education in Complementary and Integrative Medical Therapies, Harvard Medical School, The Landmark Center, Suite 22-A, Boston, MA 02215, USA. peter_wayne@hms.harvard.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

20193083

Citation

Wayne, Peter M., et al. "Tai Chi for Osteopenic Women: Design and Rationale of a Pragmatic Randomized Controlled Trial." BMC Musculoskeletal Disorders, vol. 11, 2010, p. 40.
Wayne PM, Buring JE, Davis RB, et al. Tai Chi for osteopenic women: design and rationale of a pragmatic randomized controlled trial. BMC Musculoskelet Disord. 2010;11:40.
Wayne, P. M., Buring, J. E., Davis, R. B., Connors, E. M., Bonato, P., Patritti, B., Fischer, M., Yeh, G. Y., Cohen, C. J., Carroll, D., & Kiel, D. P. (2010). Tai Chi for osteopenic women: design and rationale of a pragmatic randomized controlled trial. BMC Musculoskeletal Disorders, 11, 40. https://doi.org/10.1186/1471-2474-11-40
Wayne PM, et al. Tai Chi for Osteopenic Women: Design and Rationale of a Pragmatic Randomized Controlled Trial. BMC Musculoskelet Disord. 2010 Mar 1;11:40. PubMed PMID: 20193083.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tai Chi for osteopenic women: design and rationale of a pragmatic randomized controlled trial. AU - Wayne,Peter M, AU - Buring,Julie E, AU - Davis,Roger B, AU - Connors,Ellen M, AU - Bonato,Paolo, AU - Patritti,Benjamin, AU - Fischer,Mary, AU - Yeh,Gloria Y, AU - Cohen,Calvin J, AU - Carroll,Danette, AU - Kiel,Douglas P, Y1 - 2010/03/01/ PY - 2010/01/05/received PY - 2010/03/01/accepted PY - 2010/3/3/entrez PY - 2010/3/3/pubmed PY - 2010/7/10/medline SP - 40 EP - 40 JF - BMC musculoskeletal disorders JO - BMC Musculoskelet Disord VL - 11 N2 - 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. SN - 1471-2474 UR - https://www.unboundmedicine.com/medline/citation/20193083/Tai_Chi_for_osteopenic_women:_design_and_rationale_of_a_pragmatic_randomized_controlled_trial_ DB - PRIME DP - Unbound Medicine ER -