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

December 22, 2009
December 23, 2009
January 2008
February 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01039012 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Tai Chi for Osteopenic Women
Tai Chi for Osteopenic Women: A Pilot Randomized Controlled Trial

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Osteopenia
  • 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.
  • Tai Chi plus Standard Care
    Intervention: Other: Tai Chi
  • Standard Care
    Intervention: Other: Standard Care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
86
June 2010
February 2010   (final data collection date for primary outcome measure)

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
Female
45 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01039012
R21AT003503
No
Peter M. Wayne, PhD, Assistant Professor of Medicine, Harvard Medical School
Harvard University Faculty of Medicine
Not Provided
Not Provided
Harvard University Faculty of Medicine
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP