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Trial record 1 of 212 for:    Activities for Cognitive Enhancement of Seniors
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Activities for Cognitive Enhancement of Seniors (ACE-Seniors)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Victor W. Henderson, Stanford University
ClinicalTrials.gov Identifier:
NCT01094509
First received: March 25, 2010
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Aging
Behavioral: Tai Chi
Behavioral: Guided autobiography
Behavioral: Qigong
Behavioral: Successful aging
Behavioral: Combination
Behavioral: Comparison

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Tai Chi and Guided Autobiography for Remediation of Age-related Cognitive Decline

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Cognitive (executive function and episodic memory) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other cognitive measures [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Physical performance and other non-cognitive measures [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Adherence and retention [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 175
Study Start Date: March 2010
Study Completion Date: December 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tai Chi
Tai Chi exercises
Behavioral: Tai Chi
Tai Chi classes and exercises
Experimental: Guided autobiography
Autobiographical writing during class sessions and at home
Behavioral: Guided autobiography
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)
Behavioral: Qigong
Qigong classes and exercises (exploratory)
Active Comparator: Successful aging
Seminars on the theme of successful aging
Behavioral: Successful aging
Seminar series on the theme of successful aging
Experimental: Combination
Combination of Tai Chi exercises and autobiographical writing
Behavioral: Combination
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)
Behavioral: Comparison
No assigned behavioral activity (exploratory)

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01094509

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Dr Victor Henderson Stanford University
  More Information

No publications provided

Responsible Party: Victor W. Henderson, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01094509     History of Changes
Other Study ID Numbers: SU-02042010-4903, R01AG034639
Study First Received: March 25, 2010
Last Updated: November 18, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 20, 2014