Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
86 participants
INTERVENTIONAL
2008-01-31
2010-06-30
Brief Summary
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Detailed Description
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Tai Chi, a mind-body exercise that is growing in popularity in the U.S., shows may be an effective, safe and practical intervention for women with low bone density. Preliminary studies suggest Tai Chi can reduce rates of BMD decline in post-menopausal women. While suggestive, these studies have numerous design limitations.
We propose a pilot randomized controlled trial to assess the efficacy and feasibility of Tai Chi as an adjunct to standard care for post-menopausal osteopenic women. Eight-six osteopenic women ages 45-70 will be recruited from a large multi-specialty group practice. Our primary aim is to assess the feasibility for recruiting and retaining osteopenic women into a randomized controlled trial of 9 months of Tai Chi. Our secondary aim is to collect preliminary data on the efficacy of Tai Chi in reducing rates of bone loss in osteopenic women using sensitive markers of bone turnover and dual-energy x-ray absorptiometry. The results of this study will inform the design of a future trial evaluating the benefits and safety for Tai Chi for osteopenic women, as well as the physiological and biomechanical mechanisms through which Tai Chi may impact BMD and fracture risks associated with osteopenia.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tai Chi plus Standard Care
Tai Chi
Participants randomized to the Tai Chi group select a Tai Chi school from a pre-screened list of community-based Tai Chi programs and enroll for 9 months. Participants are asked to attend classes twice a week for the first month and once a week for the remaining 8 months. They are also asked to practice at home, or attend more classes for 2-3 additional hours per week. While in the study they are also encouraged to follow the standard care as recommended by their physician.
Standard Care
Standard Care
Participant follow the standard care recommended by their physician.
Interventions
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Tai Chi
Participants randomized to the Tai Chi group select a Tai Chi school from a pre-screened list of community-based Tai Chi programs and enroll for 9 months. Participants are asked to attend classes twice a week for the first month and once a week for the remaining 8 months. They are also asked to practice at home, or attend more classes for 2-3 additional hours per week. While in the study they are also encouraged to follow the standard care as recommended by their physician.
Standard Care
Participant follow the standard care recommended by their physician.
Eligibility Criteria
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Inclusion Criteria
* BMD T-scores of the hip (femoral neck or trochanter) and/or spine between -1.0 and -2.5
* Post-menopausal w/out menses for ≥ 12 months
* Sedentary, i.e. do not regularly participate in physical exercise on average 1 or more times per week
Exclusion Criteria
* Prior or current use of use of medication that increase risks of fracture (e.g. steroids, anti-convulsants, anticoagulants, lithium)
* Prior or current use of medications that modify bone metabolism (e.g. bisphosphonates, selective estrogen receptor modulators such as Raloxifene)
* Use of calcium supplements above levels suggested within the recommendations of standard care (i.e., above 1200-1500 mg)
* Current or prior year use of estrogen or calcitonin
* Malignancies other than skin cancer
* Diagnosis of anorexia along with a BMI of \< 17.5
* Conditions that cause secondary osteoporosis (e.g. Cushing's syndrome, Marfan's syndrome)
* Tobacco use in past year
* Physical or mental disabilities that will preclude informed consent or active study participation
* Geographic or scheduling limitations that would preclude required participation in weekly Tai Chi classes and study procedures
* Current regular practice of Tai Chi
45 Years
70 Years
FEMALE
No
Sponsors
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Harvard University Faculty of Medicine
OTHER
Responsible Party
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Harvard Medical School
Locations
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Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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References
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Wayne PM, Kiel DP, Buring JE, Connors EM, Bonato P, Yeh GY, Cohen CJ, Mancinelli C, Davis RB. Impact of Tai Chi exercise on multiple fracture-related risk factors in post-menopausal osteopenic women: a pilot pragmatic, randomized trial. BMC Complement Altern Med. 2012 Jan 30;12:7. doi: 10.1186/1472-6882-12-7.
Wayne PM, Buring JE, Davis RB, Connors EM, Bonato P, Patritti B, Fischer M, Yeh GY, Cohen CJ, Carroll D, Kiel DP. Tai Chi for osteopenic women: design and rationale of a pragmatic randomized controlled trial. BMC Musculoskelet Disord. 2010 Mar 1;11:40. doi: 10.1186/1471-2474-11-40.
Other Identifiers
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