Tai Chi for Osteopenic Women
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Osteopenia||Other: Tai Chi Other: Standard Care||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|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.
Other: Standard Care
Participant follow the standard care recommended by their physician.
- 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 ]
- Bone mass density of the lumbar spine and proximal femur (dual-energy X-ray absorptiometry). [ Time Frame: Baseline, 9 months ]
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT01039012
|United States, Massachusetts|
|Spaulding Rehabilitation Hospital|
|Boston, Massachusetts, United States, 02114|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|