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

NCT01696019 | Completed

• 1 other identifier: Byrd-ARG2007
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in whole brain volume

  Baseline, 8 months

Study Arms (4)

Fast walking

EXPERIMENTAL

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

Tai Chi

ACTIVE COMPARATOR

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

Intellectual stimulation

ACTIVE COMPARATOR

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

Contact and testing only

PLACEBO COMPARATOR

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

Interventions

Fast walking 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.

Fast walking

Tai Chi 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.

Tai Chi

Intellectual stimulation 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.

Intellectual stimulation

Contact and testing only OTHER

Contact and testing only

Eligibility Criteria

• Age: 60 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• living in defined area
• either sex
• aged 60-79

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead
• Fudan University: collaborator

Study Sites (1)

Huashan Hospital

Shanghai, China

Location

Related 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(4):757-66. doi: 10.3233/JAD-2012-120079.

  PMID: 22451320 RESULT

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Alzheimer Disease; Motor Activity

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• James A Mortimer, Ph.D.

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: September 28, 2012
• Study Start: July 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 28, 2012

Record last verified: 2012-09

Locations

CN (1)