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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264614
• Other study ID #: MIRB#00663
• Status: Completed
• Phase: N/A
• First received: December 21, 2010
• Last updated: March 9, 2015
• Start date: December 2010
• Est. completion date: April 2011

Study information

• Verified date: March 2015
• Source: Union College, New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognition Disorders
• Cognitive Decline
• Dementia
• Mild Cognitive Impairment

Intervention

Behavioral:
• Strengthening exercise
3 months of 3-5 times per week of low-intensity exercises using a chair and small weights

Locations

Country	Name	City	State
United States	Stratton VA Medical Center	Albany	New York

Sponsors (2)

Lead Sponsor	Collaborator
Union College, New York	VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and 3 months	No
Primary	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).	Baseline and 3 months	No
Primary	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).	Baseline and 3 months	No
Primary	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).	Baseline and 3 months	No
Primary	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).	Baseline and 3 months	No
Primary	Neurophysiological Function Pre- & Post- Intervention	Resting EEG and ERP recordings before (T1) and after (T2) strengthening exercise intervention	Baseline and 3 months	No