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

This study has been completed.
Sponsor:
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
Cay Anderson-Hanley, Union College, New York
ClinicalTrials.gov Identifier:
NCT01264614
First received: December 21, 2010
Last updated: March 9, 2015
Last verified: March 2015
  Purpose
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.

Condition Intervention
Cognitive Decline
Dementia
Alzheimer's Disease
Mild Cognitive Impairment
Behavioral: Strengthening exercise

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neuropsychological and Neuroimaging Effects of Strengthening Exercise for Early Dementia and Normative Older Adults

Resource links provided by NLM:


Further study details as provided by Union College, New York:

Primary Outcome Measures:
  • Stroop Test Performance From Pre- to Post-intervention [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    Resting EEG and ERP recordings before (T1) and after (T2) strengthening exercise intervention


Enrollment: 22
Study Start Date: December 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Strong Bones Program

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.
  Eligibility

Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264614

Locations
United States, New York
Stratton VA Medical Center
Albany, New York, United States, 12208
Sponsors and Collaborators
Union College, New York
VA Office of Research and Development
Investigators
Principal Investigator: Cay Anderson-Hanley, PhD Union College
  More Information

Publications:
Responsible Party: Cay Anderson-Hanley, Principal Investigator, Union College, New York
ClinicalTrials.gov Identifier: NCT01264614     History of Changes
Other Study ID Numbers: MIRB#00663 
Study First Received: December 21, 2010
Results First Received: December 2, 2014
Last Updated: March 9, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Union College, New York:
exercise
neuropsychological
dementia
Alzheimer's Disease
mild cognitive impairment
strength
MCI
AD
EEG
neurophysiological
growth factor
cognitive decline
executive function

Additional relevant MeSH terms:
Dementia
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 27, 2016