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

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.

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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