Effects of Strengthening Exercise on the Brain for Early Dementia and Normative Older Adults

March 9, 2015 updated by: Cay Anderson-Hanley, Union College, New York

Neuropsychological and Neuroimaging Effects of Strengthening Exercise for Early Dementia and Normative Older Adults

This study will evaluate the effects of low-intensity strengthening exercise on the brain (thinking and processing speed) for patients with early dementia, compared with normative older adults. Participants will engage in 3 months of exercise 3-5 times per week using a chair and small weights. It is hypothesized that there will be a significant improvement in brain function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Objective(s): This study will evaluate the neuropsychological and neurophysiological effects of low-intensity strengthening exercise for patients with early dementia, compared with normative older adults.
  2. Research Design: This is a quasi-experimental design in which change over time as a result of the exercise intervention will be compared with change over time seen in a normative sample.
  3. Methodology: The aim is to enroll 12 participants with early dementia and 12 normative controls, all who are interested in starting a strengthening exercise program. Neuropsychological evaluation, resting electroencephalography (EEG), and event-related potentials (ERP) data collection will commence prior to the start of exercise. Participants will participate in an exercise class 2-3x/wk for three months. Repeat neuropsychological, EEG, and ERP evaluations will occur at the conclusion of three months of exercise. The exercises consist of low-intensity exercises, using a chair and small weights. A leader trained in the Tufts University exercise model will conduct the classes.
  4. Findings: The investigators hypothesize a positive impact of exercise on neuropsychological function, especially performance on tasks requiring executive functions. This change will be compared with performance of normative controls who also exercise. Changes in brain function will be explored using EEG and ERP, and results are expected to be similar to prior research examining older adult exercisers which shows improvement in function.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Albany, New York, United States, 12208
        • Stratton VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult Day Program Participants with early dementia able to consent or assent with surrogate permission
  • Control participants (55-100+ yo) able to participate at location with doctor permission

Exclusion Criteria:

  • history of significant TBI, psychiatric condition, substance abuse, physical conditions that preclude participation in cognitive testing or strengthening exercises

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early stage dementia
Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week. Participants engaged in a strengthening exercise program three to five times per week for 10 weeks.
Behavioral: Strengthening exercise
3 months of 3-5 times per week of low-intensity exercises using a chair and small weights
Other Names:
  • Strong Bones Program
Active Comparator: Normative older adults
Normative older adults with no known neurological condition. Participants engaged in a strengthening exercise program three to five times per week for 10 weeks.
Behavioral: Strengthening exercise
3 months of 3-5 times per week of low-intensity exercises using a chair and small weights
Other Names:
  • Strong Bones Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroop Test Performance From Pre- to Post-intervention
Time Frame: Baseline and 3 months
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Lower scores on Stroop C (possible range 0-240 sec) represents better performance).
Baseline and 3 months
Digits Backwards Test Performance From Pre- to Post-intervention
Time Frame: Baseline and 3 months
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Digits backwards possible score range is 0-14 points).
Baseline and 3 months
Color Trails Test Performance From Pre- to Post-intervention
Time Frame: Baseline and 3 months
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Color Trails possible score range is 0-300 seconds).
Baseline and 3 months
Fuld Test Performance From Pre- to Post-intervention
Time Frame: Baseline and 3 months
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Fuld Semantic Recall possible score range is 0-20 points; Fuld Immediate and Delayed Recall possible score range is 0-10).
Baseline and 3 months
Figure Copy & Delayed Test Performance From Pre- to Post-intervention
Time Frame: Baseline and 3 months
Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Figure Copy & Delayed possible score range is 0-36 points).
Baseline and 3 months
Neurophysiological Function Pre- & Post- Intervention
Time Frame: Baseline and 3 months
Resting EEG and ERP recordings before (T1) and after (T2) strengthening exercise intervention
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Union College, New York

Collaborators

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Cay Anderson-Hanley, PhD, Union College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

December 21, 2010

First Submitted That Met QC Criteria

December 21, 2010

First Posted (Estimate)

December 22, 2010

Study Record Updates

Last Update Posted (Estimate)

March 11, 2015

Last Update Submitted That Met QC Criteria

March 9, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIRB#00663

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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