Effects of Strengthening Exercise on the Brain for Early Dementia and Normative Older Adults
Primary Purpose
Cognitive Decline, Dementia, Alzheimer's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strengthening exercise
Sponsored by
About this trial
This is an interventional treatment trial for Cognitive Decline focused on measuring exercise, neuropsychological, dementia, Alzheimer's Disease, mild cognitive impairment, strength, MCI, AD, EEG, neurophysiological, growth factor, cognitive decline, executive function
Eligibility Criteria
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
Sites / Locations
- Stratton VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early stage dementia
Normative older adults
Arm Description
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.
Normative older adults with no known neurological condition. Participants engaged in a strengthening exercise program three to five times per week for 10 weeks.
Outcomes
Primary Outcome Measures
Stroop Test Performance From Pre- to Post-intervention
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).
Digits Backwards Test Performance From Pre- to Post-intervention
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).
Color Trails Test Performance From Pre- to Post-intervention
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).
Fuld Test Performance From Pre- to Post-intervention
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).
Figure Copy & Delayed Test Performance From Pre- to Post-intervention
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).
Neurophysiological Function Pre- & Post- Intervention
Resting EEG and ERP recordings before (T1) and after (T2) strengthening exercise intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT01264614
First Posted
December 21, 2010
Last Updated
March 9, 2015
Sponsor
Union College, New York
Collaborators
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT01264614
Brief Title
Effects of Strengthening Exercise on the Brain for Early Dementia and Normative Older Adults
Official Title
Neuropsychological and Neuroimaging Effects of Strengthening Exercise for Early Dementia and Normative Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Union College, New York
Collaborators
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline, Dementia, Alzheimer's Disease, Mild Cognitive Impairment
Keywords
exercise, neuropsychological, dementia, Alzheimer's Disease, mild cognitive impairment, strength, MCI, AD, EEG, neurophysiological, growth factor, cognitive decline, executive function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early stage dementia
Arm Type
Experimental
Arm Description
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.
Arm Title
Normative older adults
Arm Type
Active Comparator
Arm Description
Normative older adults with no known neurological condition. Participants engaged in a strengthening exercise program three to five times per week for 10 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Strengthening exercise
Other Intervention Name(s)
Strong Bones Program
Intervention Description
3 months of 3-5 times per week of low-intensity exercises using a chair and small weights
Primary Outcome Measure Information:
Title
Stroop Test Performance From Pre- to Post-intervention
Description
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).
Time Frame
Baseline and 3 months
Title
Digits Backwards Test Performance From Pre- to Post-intervention
Description
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).
Time Frame
Baseline and 3 months
Title
Color Trails Test Performance From Pre- to Post-intervention
Description
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).
Time Frame
Baseline and 3 months
Title
Fuld Test Performance From Pre- to Post-intervention
Description
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).
Time Frame
Baseline and 3 months
Title
Figure Copy & Delayed Test Performance From Pre- to Post-intervention
Description
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).
Time Frame
Baseline and 3 months
Title
Neurophysiological Function Pre- & Post- Intervention
Description
Resting EEG and ERP recordings before (T1) and after (T2) strengthening exercise intervention
Time Frame
Baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cay Anderson-Hanley, PhD
Organizational Affiliation
Union College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stratton VA Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22136405
Citation
Yerokhin V, Anderson-Hanley C, Hogan MJ, Dunnam M, Huber D, Osborne S, Shulan M. Neuropsychological and neurophysiological effects of strengthening exercise for early dementia: a pilot study. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2012;19(3):380-401. doi: 10.1080/13825585.2011.628378. Epub 2011 Dec 2.
Results Reference
result
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Effects of Strengthening Exercise on the Brain for Early Dementia and Normative Older Adults
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