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Completed

NCT Number: NCT01264614

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

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stratton VA Medical Center

Albany, New York, 12208, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strengthening exercise

Behavioral

3 months of 3-5 times per week of low-intensity exercises using a chair and small weights

Other names: Strong Bones Program

Primary outcomes

  1. Stroop Test Performance From Pre- to Post-intervention

    Time frame: Baseline and 3 months

    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).

  2. Digits Backwards Test Performance From Pre- to Post-intervention

    Time frame: Baseline and 3 months

    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).

  3. Color Trails Test Performance From Pre- to Post-intervention

    Time frame: Baseline and 3 months

    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).

  4. Fuld Test Performance From Pre- to Post-intervention

    Time frame: Baseline and 3 months

    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).

  5. Figure Copy & Delayed Test Performance From Pre- to Post-intervention

    Time frame: Baseline and 3 months

    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).

  6. Neurophysiological Function Pre- & Post- Intervention

    Time frame: Baseline and 3 months

    Resting EEG and ERP recordings before (T1) and after (T2) strengthening exercise intervention

Sponsors and collaborators

Lead sponsor

Union College, New York

Other

Collaborators

  • US Department of Veterans Affairs

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 22, 2010
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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