Tai Chi for Osteopenic Women

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2009 by Harvard University Faculty of Medicine.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Harvard University Faculty of Medicine

ClinicalTrials.gov Identifier:

NCT01039012

First received: December 22, 2009

Last updated: December 23, 2009

Last verified: December 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	December 22, 2009
Last Updated Date	December 23, 2009
Start Date ^ICMJE	January 2008
Estimated Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 23, 2009)	Serum markers of bone resorption (CTX, C-terminal cross linking telopeptide of type I collagen), and bone formation (osteocalcin). [ Time Frame: Baseline, 3 months, 9 months ] [ Designated as safety issue: No ] Bone mass density of the lumbar spine and proximal femur (dual-energy X-ray absorptiometry). [ Time Frame: Baseline, 9 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01039012 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 23, 2009)	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). [ Time Frame: Baseline, 3 months, 9 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Tai Chi for Osteopenic Women
Official Title ^ICMJE	Tai Chi for Osteopenic Women: A Pilot Randomized Controlled Trial
Brief Summary	This study will assess the effectiveness of Tai Chi to affect the rate of bone loss in post-menopausal women who have been diagnosed with the initial stages of bone thinning.
Detailed Description	Osteopenia is a serious and growing public health concern for women. Osteopenic women are at greater risk for fractures than women with normal bone mineral densities (BMD). Low BMD-related fractures are associated with significant long-term impairment, high morbidity rates and high medical costs. Optimal preventive and sustainable interventions for osteopenic women are not yet well-defined. 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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Osteopenia
Intervention ^ICMJE	Other: 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. Other: Standard Care Participant follow the standard care recommended by their physician.
Study Arm (s)	Tai Chi plus Standard Care Intervention: Other: Tai Chi Standard Care Intervention: Other: Standard Care
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	86
Estimated Completion Date	June 2010
Estimated Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Women ages 45-70 years 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: Osteoporotic (T-score < -2.5) or a fracture in the past 2 years not caused by motor vehicle accident 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
Gender	Female
Ages	45 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01039012
Other Study ID Numbers ^ICMJE	R21AT003503
Has Data Monitoring Committee	No
Responsible Party	Peter M. Wayne, PhD, Assistant Professor of Medicine, Harvard Medical School
Study Sponsor ^ICMJE	Harvard University Faculty of Medicine
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Harvard University Faculty of Medicine
Verification Date	December 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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