ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Tai Chi on Frailty in Elderly Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tai Chi Group 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).
Educational Control Group 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)

Participant Flow:   Overall Study
    Tai Chi Group   Educational Control Group
STARTED   35   31 
COMPLETED   29   28 
NOT COMPLETED   6   3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tai Chi Group 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).
Educational Control Group 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 Total of all reporting groups

Baseline Measures
   Tai Chi Group   Educational Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   31   66 
Age 
[Units: Years]
Mean (Standard Deviation)
 87  (5)   86  (6)   87  (6) 
Gender 
[Units: Participants]
     
Female   7   7   14 
Male   28   24   52 
Frailty Index 
[Units: Participants]
     
Frail   10   6   16 
Prefrail   20   23   43 
Nonfrail   5   2   7 


  Outcome Measures

1.  Primary:   Frailty Index   [ Time Frame: post-intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: lipsitz@hsl.harvard.edu



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