Activities for Cognitive Enhancement of Seniors

Aging Clinical Trial

— ACE-Seniors  

Official title:

Tai Chi and Guided Autobiography for Remediation of Age-related Cognitive Decline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01094509
• Other study ID #: SU-02042010-4903
• Secondary ID: R01AG034639
• Status: Completed
• Phase: N/A
• First received: March 25, 2010
• Last updated: November 18, 2014
• Start date: March 2010
• Est. completion date: December 2013

Study information

• Verified date: November 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: December 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aging

Intervention

Behavioral:
• Tai Chi
Tai Chi classes and exercises
• Guided autobiography
Autobiographical writing in class and at home
• Qigong
Qigong classes and exercises (exploratory)
• Successful aging
Seminar series on the theme of successful aging
• Combination
Combination of Tai Chi exercises and autobiographical writing
• Comparison
No assigned behavioral activity (exploratory)

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive (executive function and episodic memory)		6 and 12 months	No
Secondary	Other cognitive measures		6 and 12 months	No
Secondary	Physical performance and other non-cognitive measures		6 and 12 months	No
Secondary	Adherence and retention		6 and 12 months	No