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Activities for Cognitive Enhancement of Seniors

NCT ID: NCT01094509

Last Updated: 2014-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tai Chi

Tai Chi exercises

Group Type EXPERIMENTAL

Tai Chi

Intervention Type BEHAVIORAL

Tai Chi classes and exercises

Guided autobiography

Autobiographical writing during class sessions and at home

Group Type EXPERIMENTAL

Guided autobiography

Intervention Type BEHAVIORAL

Autobiographical writing in class and at home

Qigong

Qigong exercises (exploratory, not part of the original protocol, added to gain experience with this intervention)

Group Type EXPERIMENTAL

Qigong

Intervention Type BEHAVIORAL

Qigong classes and exercises (exploratory)

Successful aging

Seminars on the theme of successful aging

Group Type ACTIVE_COMPARATOR

Successful aging

Intervention Type BEHAVIORAL

Seminar series on the theme of successful aging

Combination

Combination of Tai Chi exercises and autobiographical writing

Group Type EXPERIMENTAL

Combination

Intervention Type BEHAVIORAL

Combination of Tai Chi exercises and autobiographical writing

Comparison

No assigned experimental activity (exploratory, not part of the original protocol, added to gain experience with a placebo comparator)

Group Type PLACEBO_COMPARATOR

Comparison

Intervention Type BEHAVIORAL

No assigned behavioral activity (exploratory)

Interventions

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Tai Chi

Tai Chi classes and exercises

Intervention Type BEHAVIORAL

Guided autobiography

Autobiographical writing in class and at home

Intervention Type BEHAVIORAL

Qigong

Qigong classes and exercises (exploratory)

Intervention Type BEHAVIORAL

Successful aging

Seminar series on the theme of successful aging

Intervention Type BEHAVIORAL

Combination

Combination of Tai Chi exercises and autobiographical writing

Intervention Type BEHAVIORAL

Comparison

No assigned behavioral activity (exploratory)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Victor W. Henderson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr Victor Henderson

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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R01AG034639

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SU-02042010-4903

Identifier Type: -

Identifier Source: org_study_id