Tai Chi for Osteopenic Women

Osteopenia Clinical Trial

Official title:

Tai Chi for Osteopenic Women: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01039012
• Other study ID #: R21AT003503
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 22, 2009
• Last updated: December 23, 2009
• Start date: January 2008
• Est. completion date: June 2010

Study information

• Verified date: December 2009
• Source: Harvard University Faculty of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 86
• Est. completion date: June 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteopenia

Intervention

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
Participant follow the standard care recommended by their physician.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Harvard University Faculty of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum markers of bone resorption (CTX, C-terminal cross linking telopeptide of type I collagen), and bone formation (osteocalcin).		Baseline, 3 months, 9 months	No
Primary	Bone mass density of the lumbar spine and proximal femur (dual-energy X-ray absorptiometry).		Baseline, 9 months	No
Secondary	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).		Baseline, 3 months, 9 months	No