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
Recruitment status was Recruiting
Sponsor:
Union College, New York
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
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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:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
Dementia
Exercise and Physical Fitness
Mild Cognitive Impairment
U.S. FDA Resources
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:
- 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, 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.
- 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
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 June 18, 2013