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Tai Chi for Osteopenic Women

Primary Purpose

Osteopenia

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tai Chi
Standard Care
Sponsored by
Harvard University Faculty of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteopenia focused on measuring bone mineral density, osteoporosis, exercise, bone remodeling, biomotion analysis

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Spaulding Rehabilitation Hospital
  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Tai Chi plus Standard Care

Standard Care

Arm Description

Outcomes

Primary Outcome Measures

Serum markers of bone resorption (CTX, C-terminal cross linking telopeptide of type I collagen), and bone formation (osteocalcin).
Bone mass density of the lumbar spine and proximal femur (dual-energy X-ray absorptiometry).

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).

Full Information

First Posted
December 22, 2009
Last Updated
December 23, 2009
Sponsor
Harvard University Faculty of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01039012
Brief Title
Tai Chi for Osteopenic Women
Official Title
Tai Chi for Osteopenic Women: A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Harvard University Faculty of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia
Keywords
bone mineral density, osteoporosis, exercise, bone remodeling, biomotion analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tai Chi plus Standard Care
Arm Type
Other
Arm Title
Standard Care
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Tai Chi
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Participant follow the standard care recommended by their physician.
Primary Outcome Measure Information:
Title
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
Title
Bone mass density of the lumbar spine and proximal femur (dual-energy X-ray absorptiometry).
Time Frame
Baseline, 9 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22289280
Citation
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.
Results Reference
derived
PubMed Identifier
20193083
Citation
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.
Results Reference
derived

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Tai Chi for Osteopenic Women

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