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Tai Chi for Osteopenic Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01039012
Recruitment Status : Unknown
Verified December 2009 by Harvard University Faculty of Medicine.
Recruitment status was:  Active, not recruiting
First Posted : December 24, 2009
Last Update Posted : December 24, 2009
Information provided by:
Harvard University Faculty of Medicine

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.

Condition or disease Intervention/treatment Phase
Osteopenia Other: Tai Chi Other: Standard Care Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tai Chi for Osteopenic Women: A Pilot Randomized Controlled Trial
Study Start Date : January 2008
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : June 2010

Arm Intervention/treatment
Tai Chi plus Standard Care 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.

Standard Care Other: Standard Care
Participant follow the standard care recommended by their physician.

Primary Outcome Measures :
  1. 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 ]
  2. Bone mass density of the lumbar spine and proximal femur (dual-energy X-ray absorptiometry). [ Time Frame: Baseline, 9 months ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01039012

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United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Harvard University Faculty of Medicine

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Peter M. Wayne, PhD, Assistant Professor of Medicine, Harvard Medical School Identifier: NCT01039012     History of Changes
Other Study ID Numbers: R21AT003503 ( U.S. NIH Grant/Contract )
First Posted: December 24, 2009    Key Record Dates
Last Update Posted: December 24, 2009
Last Verified: December 2009
Keywords provided by Harvard University Faculty of Medicine:
bone mineral density
bone remodeling
biomotion analysis
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases