Randomized Trial of Exercise and Social Interaction in a Community-Based Sample of Non-Demented Chinese Elders

Alzheimer Disease Clinical Trial

— SCIBHI  

Official title:

A Pilot Randomized Intervention Study of Physical Exercise and Social Engagement in Chinese Elders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696019
• Other study ID #: Byrd-ARG2007
• Status: Completed
• Phase: N/A
• First received: September 26, 2012
• Last updated: September 27, 2012
• Start date: July 2008
• Est. completion date: September 2009

Study information

• Verified date: September 2012
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A pilot randomized clinical trial was conducted in a random sample of 120 non-demented Chinese elders (ages 60-79) living in a defined community in Shanghai, China to compare the effects of interventions (fast walking, Tai Chi, group intellectual discussion) to no intervention with respect to change in cognition and whole brain volume determined by repeated neuropsychological batteries and MRI scans. Aims included determining the feasibility of recruiting and retaining a random sample of people age 60+ for such a trial as well as collection of preliminary data on the efficacy of the interventions. The long-term goal of this research program is to determine whether sustained physical and/or mental exercise interventions are efficacious in delaying the onset of dementia and to understand the role and mechanisms of brain growth in this process.

Description:

Physical exercise has been shown to increase brain volume and improve cognition in randomized trials of non-demented elderly. Although greater social engagement was found to reduce dementia risk in observational studies, randomized trials of social interventions have not been reported. A representative sample of 120 elderly from Shanghai, China was randomized to four groups (Tai Chi, Walking, Social Interaction, No Intervention) for 40 weeks. Two MRI's were obtained, one before the intervention period, the other after. A neuropsychological battery was administered at baseline, 20 weeks and 40 weeks. Comparison of changes in brain volumes in intervention groups with the No Intervention group were assessed by t-tests. Time-intervention group interactions for neuropsychological measures were evaluated with repeated-measures mixed models.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 79 Years

Eligibility

Inclusion Criteria:

• living in defined area

• either sex

• aged 60-79

Exclusion Criteria:

• history of stroke, Parkinson's disease or other neurologic disease

• inability to walk unassisted for two kilometers or maintain balance with feet side-by-side or semi-tandem for 10 seconds each

• education-adjusted Chinese Mini-Mental Examination score < 26 (to exclude individuals with dementia or moderate cognitive impairment

• cardiovascular or musculoskeletal conditions that would be contraindicated for the intervention programs

• contraindications for MRI

• diagnosis of any illness that would preclude participation in the full study

• regular vigorous exercise or Tai Chi practice.

Study Design

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognition Disorders
• Cognitive Impairment
• Dementia
• Mild Cognitive Impairment

Intervention

Other:
• Fast walking
Participants assigned to this group met with two group leaders three times per week in the morning in Jing An Park and were encouraged to walk quickly around a 400 meter circular route. Each session consisted of 10 minutes of warm-up stretching, 30 minutes of brisk walking, and 10 minutes of cool-down exercises. Prior to the first session, each participant was given a pedometer with their name on it. They were asked to take 100 steps and the sensitivity and positioning of the pedometer was adjusted to assure accurate measurement. At the termination of each session, the pedometers were collected and the number of steps taken by each participant at that session recorded. A record of the number of steps taken for every participant at each session over the 40 week period was maintained.
• Tai Chi
Participants assigned to this group met with a Tai Chi master and assistant three times per week in the morning in Jing An Park or at a nearby gymnasium depending on weather conditions. Each session included 20 min of warm-up exercises (lower back and hamstring stretching, gentle calisthenics, and balance training), 20 min of Tai Chi practice, and 10 min of cool-down exercises.
• Intellectual stimulation
Participants assigned to this group met with a group leader and an assistant for one hour three times a week in the morning at the neighborhood community center. Although direction was initially given regarding subjects for discussion, the participants decided on their own to organize and select topics themselves.
• Contact and testing only

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	Fudan University

Country where clinical trial is conducted

China, 

References & Publications (1)

Mortimer JA, Ding D, Borenstein AR, DeCarli C, Guo Q, Wu Y, Zhao Q, Chu S. Changes in brain volume and cognition in a randomized trial of exercise and social interaction in a community-based sample of non-demented Chinese elders. J Alzheimers Dis. 2012;30 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognitive performance on battery of neuropsychological tests	A comprehensive battery of neuropsychological tests was administered by a psychometrist.	Baseline, 4 months, 8 months	No
Secondary	Change in whole brain volume	Structural MRIs were obtained at baseline and 8 months to provide data from which change in whole brain volume was determined.	Baseline, 8 months	No