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

NCT ID: NCT01696019

Last Updated: 2012-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-09-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Fast walking

Intervention Type: OTHER

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.

Group Type: ACTIVE_COMPARATOR

Tai Chi

Intervention Type: OTHER

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.

Group Type: ACTIVE_COMPARATOR

Intellectual stimulation

Intervention Type: OTHER

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

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.

Group Type: PLACEBO_COMPARATOR

Contact and testing only

Intervention Type: OTHER

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Contact and testing only

Intervention Type: OTHER

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fudan University

OTHER

Sponsor Role: collaborator

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James A Mortimer, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

Huashan Hospital

Shanghai, , China

Countries

China

References

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.

Reference Type: RESULT

PMID: 22451320 (View on PubMed)

Other Identifiers

Byrd-ARG2007

Identifier Type: -

Identifier Source: org_study_id