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Effects of Tai Chi on Frailty in Elderly Adults

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ClinicalTrials.gov Identifier: NCT01126723
Recruitment Status : Completed
First Posted : May 20, 2010
Results First Posted : January 30, 2015
Last Update Posted : February 23, 2015
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Hebrew Rehabilitation Center, Boston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Frailty
Interventions Other: Tai Chi
Other: Education-Control
Enrollment 66

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tai Chi Group Educational Control Group
Hide Arm/Group Description Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week). Education-Control: 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)
Period Title: Overall Study
Started 35 31
Completed 29 28
Not Completed 6 3
Arm/Group Title Tai Chi Group Educational Control Group Total
Hide Arm/Group Description Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week). Education-Control: 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) Total of all reporting groups
Overall Number of Baseline Participants 35 31 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 31 participants 66 participants
87  (5) 86  (6) 87  (6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 31 participants 66 participants
Female
7
  20.0%
7
  22.6%
14
  21.2%
Male
28
  80.0%
24
  77.4%
52
  78.8%
Frailty Index  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants 31 participants 66 participants
Frail 10 6 16
Prefrail 20 23 43
Nonfrail 5 2 7
1.Primary Outcome
Title Frailty Index
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Tai Chi Group Educational Control Group
Hide Arm/Group Description:
Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
Education-Control: 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)
Overall Number of Participants Analyzed 29 28
Measure Type: Number
Unit of Measure: participants
Frail 7 5
Prefrail 16 21
Nonfrail 6 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tai Chi Group, Educational Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments The a priori threshold for statistical significance was set to 0.05.
Method Fisher Exact
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tai Chi Group Educational Control Group
Hide Arm/Group Description Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week). Education-Control: 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)
All-Cause Mortality
Tai Chi Group Educational Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tai Chi Group Educational Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/31 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tai Chi Group Educational Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/31 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Lewis Lipsitz
Organization: Institute for Aging Research, Hebrew SeniorLife
Phone: 617-971-5318
Responsible Party: Hebrew Rehabilitation Center, Boston
ClinicalTrials.gov Identifier: NCT01126723     History of Changes
Other Study ID Numbers: 10-005
R37AG025037 ( U.S. NIH Grant/Contract )
First Submitted: May 18, 2010
First Posted: May 20, 2010
Results First Submitted: January 20, 2015
Results First Posted: January 30, 2015
Last Update Posted: February 23, 2015