search
Back to results

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

Primary Purpose

Cognitive Impairment, Dementia, Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fast walking
Tai Chi
Intellectual stimulation
Contact and testing only
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Impairment focused on measuring magnetic resonance imaging, cognition, Tai Chi, physical exercise, mental exercise, intervention trial, prevention, dementia, Alzheimer disease, mild cognitive impairment

Eligibility Criteria

60 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Huashan Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Fast walking

Tai Chi

Intellectual stimulation

Contact and testing only

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in cognitive performance on battery of neuropsychological tests
A comprehensive battery of neuropsychological tests was administered by a psychometrist.

Secondary Outcome Measures

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.

Full Information

First Posted
September 26, 2012
Last Updated
September 27, 2012
Sponsor
University of South Florida
Collaborators
Fudan University
search

1. Study Identification

Unique Protocol Identification Number
NCT01696019
Brief Title
Randomized Trial of Exercise and Social Interaction in a Community-Based Sample of Non-Demented Chinese Elders
Acronym
SCIBHI
Official Title
A Pilot Randomized Intervention Study of Physical Exercise and Social Engagement in Chinese Elders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
Fudan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fast walking
Arm Type
Experimental
Arm Description
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.
Arm Title
Tai Chi
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intellectual stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Contact and testing only
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Fast walking
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Tai Chi
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Intellectual stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Contact and testing only
Primary Outcome Measure Information:
Title
Change in cognitive performance on battery of neuropsychological tests
Description
A comprehensive battery of neuropsychological tests was administered by a psychometrist.
Time Frame
Baseline, 4 months, 8 months
Secondary Outcome Measure Information:
Title
Change in whole brain volume
Description
Structural MRIs were obtained at baseline and 8 months to provide data from which change in whole brain volume was determined.
Time Frame
Baseline, 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James A Mortimer, Ph.D.
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huashan Hospital
City
Shanghai
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22451320
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs