- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01094509
Activities for Cognitive Enhancement of Seniors (ACE-Seniors)
November 18, 2014 updated by: Victor W. Henderson, Stanford University
Tai Chi and Guided Autobiography for Remediation of Age-related Cognitive Decline
Cognitive aging and cognitive decline are important public health concerns in an aging US population.
The investigators will conduct a randomized controlled trail among healthy older adults to assess effects of several innovative activities on remediation of age-related cognitive decline.
Study Overview
Status
Completed
Conditions
Detailed Description
ACE-Seniors is designed as a single-site trial of four randomly assigned interventions, Tai Chi exercise, autobiographical writing, both Tai Chi and autobiography (dual intervention), and general health education.
Participants are relatively healthy adults aged 70 years or older, who are not regular practitioners of Tai Chi or regular writers.
They are without medical or neurological disorders that would substantially limit the ability to participate in study interventions, without dementia or mild cognitive impairment, relatively sedentary, able to walk unassisted, and able to score 4 or better on the Short Physical Performance Battery.
Interventions are administered over a 6 month period of time, with similar exposure times among the four groups.
The prespecified primary endpoint is derived from a composite neuropsychological measure, based on three tests of executive function and three tests of episodic memory.
The planned sample size is 96 (24 per group).
Intention-to-treat analysis will include all eligible participants who complete baseline assessments.
Study Type
Interventional
Enrollment (Actual)
175
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 70 years of age or older.
- No other household member already enrolled.
- In reasonably good health: no serious cognitive problem; free of any condition that would limit your ability to participate in Tai Chi classes (a moderate intensity exercise), in Qigong exercises, in a writing program, or in a seminar series.
- Not presently engaged in a regular exercise program; not presently engaged in Tai Chi Qigong or another form of Eastern exercise; and not a regular writer.
- Not now engaged in research to enhance cognitive skills.
- Willing to travel to Stanford for ACE-Seniors program classes. Planning to be in the area during most of the coming year;
- Willing to be assigned randomly (by chance) to one of the ACE-Senior activities.
Exclusion Criteria:
- Failure to meet inclusion criteria.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tai Chi
Tai Chi exercises
|
Tai Chi classes and exercises
|
Experimental: Guided autobiography
Autobiographical writing during class sessions and at home
|
Autobiographical writing in class and at home
|
Experimental: Qigong
Qigong exercises (exploratory, not part of the original protocol, added to gain experience with this intervention)
|
Qigong classes and exercises (exploratory)
|
Active Comparator: Successful aging
Seminars on the theme of successful aging
|
Seminar series on the theme of successful aging
|
Experimental: Combination
Combination of Tai Chi exercises and autobiographical writing
|
Combination of Tai Chi exercises and autobiographical writing
|
Placebo Comparator: Comparison
No assigned experimental activity (exploratory, not part of the original protocol, added to gain experience with a placebo comparator)
|
No assigned behavioral activity (exploratory)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cognitive (executive function and episodic memory)
Time Frame: 6 and 12 months
|
6 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Other cognitive measures
Time Frame: 6 and 12 months
|
6 and 12 months
|
Physical performance and other non-cognitive measures
Time Frame: 6 and 12 months
|
6 and 12 months
|
Adherence and retention
Time Frame: 6 and 12 months
|
6 and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dr Victor Henderson, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
March 25, 2010
First Submitted That Met QC Criteria
March 26, 2010
First Posted (Estimate)
March 29, 2010
Study Record Updates
Last Update Posted (Estimate)
November 20, 2014
Last Update Submitted That Met QC Criteria
November 18, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- SU-02042010-4903
- R01AG034639 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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