Tai Chi for Osteopenic Women

NCT01039012 | Unknown Phase 2

• 1 other identifier: R21AT003503
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Osteopenia

Keywords

bone mineral density; osteoporosis; exercise; bone remodeling; biomotion analysis

Outcome Measures

Primary Outcomes (2)

• Serum markers of bone resorption (CTX, C-terminal cross linking telopeptide of type I collagen), and bone formation (osteocalcin).

  Baseline, 3 months, 9 months

• Bone mass density of the lumbar spine and proximal femur (dual-energy X-ray absorptiometry).

  Baseline, 9 months

Secondary Outcomes (1)

• 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

Study Arms (2)

Tai Chi plus Standard Care

OTHER

Other: Tai Chi

Standard Care

OTHER

Other: Standard Care

Interventions

Tai Chi OTHER

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.

Tai Chi plus Standard Care

Standard Care OTHER

Participant follow the standard care recommended by their physician.

Standard Care

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard University Faculty of Medicine: lead

Study Sites (2)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

• 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.

  PMID: 22289280 DERIVED

• Wayne PM, Buring JE, Davis RB, Connors EM, Bonato P, Patritti B, Fischer M, Yeh GY, Cohen CJ, Carroll D, Kiel DP. Tai Chi for osteopenic women: design and rationale of a pragmatic randomized controlled trial. BMC Musculoskelet Disord. 2010 Mar 1;11:40. doi: 10.1186/1471-2474-11-40.

  PMID: 20193083 DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis; Motor Activity

Interventions

Tai Ji; Standard of Care

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 24, 2009
• Study Start: January 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: June 1, 2010
• Last Updated: December 24, 2009

Record last verified: 2009-12

Locations

US (2)