Back to resultsEffects of Tai Chi on Frailty in Elderly Adults
Primary Purpose
Frailty
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tai Chi
Education-Control
Sponsored by
About this trial
This is an interventional treatment trial for Frailty
Eligibility Criteria
Inclusion Criteria:
- Men and women over age 70 will be included if they are able to stand and walk unassisted, are free of any acute or unstable medical conditions, and are able to understand directions and participate in the protocol.
Exclusion Criteria:
- Potential subjects will be excluded 1) if they cannot stand and ambulate unassisted, 2) are experiencing any symptomatic cardiovascular or respiratory disease, or have 3) a myocardial infarction or stroke within 6 months, 4) painful arthritis, spinal stenosis, amputation, painful foot lesions, or neuropathy that limits balance and mobility, 5) systolic BP above 160 or diastolic BP above 100 mm Hg, 6) a cardiac pacemaker, 7) Parkinson's Disease or other neuromuscular disorder, 8) metastatic cancer or immunosuppressive therapy, or 9) have significant visual impairment.
Sites / Locations
- Hebrew Rehabilitation Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tai Chi group
Educational Control group
Arm Description
Outcomes
Primary Outcome Measures
Frailty Index
Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness.
Secondary Outcome Measures
Full Information
NCT ID
NCT01126723
First Posted
May 18, 2010
Last Updated
February 4, 2015
Sponsor
Hebrew SeniorLife
Collaborators
National Institutes of Health (NIH), National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT01126723
Brief Title
Effects of Tai Chi on Frailty in Elderly Adults
Official Title
The Effects of Tai Chi on the Nonlinear Dynamics of Frailty in Elderly Adults
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebrew SeniorLife
Collaborators
National Institutes of Health (NIH), National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is determine the effects of Tai Chi exercise, as compared to an education-based control intervention, on cardiovascular and balance system function in older people at risk of developing frailty. We hypothesize that long-term Tai Chi training will improve specific nonlinear properties associated of cardiovascular and balance dynamics in this population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tai Chi group
Arm Type
Experimental
Arm Title
Educational Control group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Tai Chi
Intervention Description
The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
Intervention Type
Other
Intervention Name(s)
Education-Control
Intervention Description
The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
Primary Outcome Measure Information:
Title
Frailty Index
Description
Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness.
Time Frame
post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women over age 70 will be included if they are able to stand and walk unassisted, are free of any acute or unstable medical conditions, and are able to understand directions and participate in the protocol.
Exclusion Criteria:
Potential subjects will be excluded 1) if they cannot stand and ambulate unassisted, 2) are experiencing any symptomatic cardiovascular or respiratory disease, or have 3) a myocardial infarction or stroke within 6 months, 4) painful arthritis, spinal stenosis, amputation, painful foot lesions, or neuropathy that limits balance and mobility, 5) systolic BP above 160 or diastolic BP above 100 mm Hg, 6) a cardiac pacemaker, 7) Parkinson's Disease or other neuromuscular disorder, 8) metastatic cancer or immunosuppressive therapy, or 9) have significant visual impairment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lewis Lipsitz, MD
Organizational Affiliation
Hebrew Rehabilitation Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hebrew Rehabilitation Center
City
Roslindale
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Tai Chi on Frailty in Elderly Adults
We'll reach out to this number within 24 hrs