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
  Purpose

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 Intervention Phase
Osteopenia
Other: Tai Chi
Other: Standard Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tai Chi for Osteopenic Women: A Pilot Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Harvard University Faculty of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 86
Study Start Date: January 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039012

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

No publications provided by Harvard University Faculty of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter M. Wayne, PhD, Assistant Professor of Medicine, Harvard Medical School
ClinicalTrials.gov Identifier: NCT01039012     History of Changes
Other Study ID Numbers: R21AT003503
Study First Received: December 22, 2009
Last Updated: December 23, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Harvard University Faculty of Medicine:
bone mineral density
osteoporosis
exercise
bone remodeling
biomotion analysis

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 21, 2014