Clinical trial NCT01696019: Randomized Trial of Exercise and Social Interaction in a Community-Based Sample of Non-Demented Chinese Elders
Official title: A Pilot Randomized Intervention Study of Physical Exercise and Social Engagement in Chinese Elders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Dementia
Mild Cognitive Impairment
Alzheimer Disease
Keywords: magnetic resonance imaging
cognition
Tai Chi
physical exercise
mental exercise
intervention trial
prevention
dementia
Alzheimer disease
mild cognitive impairment
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Fudan University
First posted: 2012-09-28
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in cognitive performance on battery of neuropsychological tests
timeFrame: Baseline, 4 months, 8 months
Secondary outcomes:
measure: Change in whole brain volume
timeFrame: Baseline, 8 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
Study officials:
affiliation: University of South Florida
name: James A Mortimer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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(4):757-66. doi: 10.3233/JAD-2012-120079.