Tai Chi for Osteopenic Women

December 23, 2009 updated by: Harvard University Faculty of Medicine

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

86

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Spaulding Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard Care
Other: Standard Care
Participant follow the standard care recommended by their physician.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, 3 months, 9 months
Bone mass density of the lumbar spine and proximal femur (dual-energy X-ray absorptiometry).
Time Frame: Baseline, 9 months
Baseline, 9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, 3 months, 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard University Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

February 1, 2010

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

December 22, 2009

First Submitted That Met QC Criteria

December 23, 2009

First Posted (Estimate)

December 24, 2009

Study Record Updates

Last Update Posted (Estimate)

December 24, 2009

Last Update Submitted That Met QC Criteria

December 23, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AT003503 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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