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

This study has been completed.
Sponsor:
Collaborator:
Fudan University
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01696019
First received: September 26, 2012
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Cognitive Impairment
Dementia
Mild Cognitive Impairment
Alzheimer Disease
Other: Fast walking
Other: Tai Chi
Other: Intellectual stimulation
Other: Contact and testing only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Pilot Randomized Intervention Study of Physical Exercise and Social Engagement in Chinese Elders

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Change in cognitive performance on battery of neuropsychological tests [ Time Frame: Baseline, 4 months, 8 months ] [ Designated as safety issue: No ]
    A comprehensive battery of neuropsychological tests was administered by a psychometrist.


Secondary Outcome Measures:
  • Change in whole brain volume [ Time Frame: Baseline, 8 months ] [ Designated as safety issue: No ]
    Structural MRIs were obtained at baseline and 8 months to provide data from which change in whole brain volume was determined.


Enrollment: 120
Study Start Date: July 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Active Comparator: 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.
Other: 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.
Active Comparator: 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.
Other: 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.
Placebo Comparator: Contact and testing only
The fourth group received no intervention. Contact was maintained by phone during the intervention period to reduce dropout. Participants were called four times during the 40 weeks intervention period by the study coordinator.
Other: Contact and testing only

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

Ages Eligible for Study:   60 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01696019

Locations
China
Huashan Hospital
Shanghai, China
Sponsors and Collaborators
University of South Florida
Fudan University
Investigators
Principal Investigator: James A Mortimer, Ph.D. University of South Florida
  More Information

Publications:
Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01696019     History of Changes
Other Study ID Numbers: Byrd-ARG2007
Study First Received: September 26, 2012
Last Updated: September 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
magnetic resonance imaging
cognition
Tai Chi
physical exercise
mental exercise
intervention trial
prevention
dementia
Alzheimer disease
mild cognitive impairment

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Dementia
Mild Cognitive Impairment
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014