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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Union College, New York.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Union College, New York
ClinicalTrials.gov Identifier:
NCT01264614
First received: December 21, 2010
Last updated: December 30, 2010
Last verified: December 2010
  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 Impairment
Dementia
Alzheimer's Disease
Mild Cognitive Impairment
Behavioral: strengthening exercises

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group 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:
  • Neuropsychological Function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Cognitive function, especially executive functions, assessed with standardized pencil and paper tests.

  • Neurophysiological Function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    This will be assessed using EEG recordings.


Secondary Outcome Measures:
  • Biomarker [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Brain-Derived Neurotrophic Factor (BDNF) will be assessed from periodic saliva samples.


Estimated Enrollment: 24
Study Start Date: December 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: strengthening exercise Behavioral: strengthening exercises
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, EEG neuroimaging, and biomarker 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 biomarker 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 biomarkers (e.g., BDNF), 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
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

Contacts
Contact: Cay Anderson-Hanley, PhD 518-388-6430 andersoc@union.edu
Contact: Mina Dunnam, PhD 518-626-5396 mina.dunnam@va.gov

Locations
United States, New York
Stratton VA Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Mina Dunnam, PhD    518-626-5396    mina.dunnam@va.gov   
Contact: Cay Anderson-Hanley, PhD    518-388-6430    andersoc@union.edu   
Principal Investigator: Cay Anderson-Hanley, PhD         
Principal Investigator: Mina Dunnam, PhD         
Sponsors and Collaborators
Union College, New York
Investigators
Principal Investigator: Cay Anderson-Hanley, PhD Union College
  More Information

Additional Information:
No publications provided

Responsible Party: Cay Anderson-Hanley, PhD - Assistant Professor, Union College
ClinicalTrials.gov Identifier: NCT01264614     History of Changes
Other Study ID Numbers: MIRB#00663
Study First Received: December 21, 2010
Last Updated: December 30, 2010
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
BDNF
growth factor
cognitive decline
executive function

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014