Exercise Training to Improve Cognitive Function
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background/Rationale:
Alzheimer's disease (AD) afflicts nearly 6 million Americans, a number projected to grow in coming decades. AD is known to have a long preclinical phase in which pathophysiologic processes develop many years, even decades, before the onset of clinical symptoms. During this preclinical phase there is evidence of unremitting decline in cognitive function, particularly in episodic memory. Thus far, evidence of the efficacy of pharmacological interventions to slow this decline in cognitive function has been limited, leading to increasing interest in the utility of nonpharmacological interventions including exercise.
Objective:
The investigators propose to assess the feasibility of a novel home-based exercise intervention to improve episodic memory in Veterans with mild cognitive impairment (MCI).
Methods:
The investigators will estimate the difference between the intervention (n=30) and the control group (n=30) on 6-month change in episodic memory (Rey-Osterrieth Complex Figure Test, Wechsler Logical Memory Test) as well as the effect size, which will be used as a basis for sample size calculation for a proposed larger study. Participants will be male and female Veterans 50 years of age or older with amnestic MCI.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Massachusetts
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Boston, Massachusetts, United States, 02130
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Amnestic MCI
- Ability to use a telephone without assistance
Exclusion Criteria:
- Angina Pectoris
- History of myocardial infarction within 6 months
- History of ventricular dysrhythmia requiring current therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise group
Structured exercise
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Exercise instruction and encouragement
|
|
Active Comparator: Control group
Health education
|
Provision of general information about a variety of health topics
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Delayed Recall Score on Wechsler Logical Memory Task From Baseline to 6 Months
Time Frame: baseline and 6 months
|
Wechsler Logical Memory Task is a recall test involving 2 short stories.
Possible scores on the delayed recall task range from 0 (no details recalled for both stories) to 50 (all details recalled on both stories).
Outcome is change in the delayed recall score from baseline to 6 months.
|
baseline and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Delayed Recall Score on the Rey-Osterrieth Complex Figure Test From Baseline to 6 Months
Time Frame: baseline and 6 months
|
Rey-Osterrieth Complex Figure Test is a recall test involving a complex figure.
Possible scores on the delayed recall task range from 0 (no accurate details recalled for the figure) to 36 (all details accurately recalled for the figure).
Outcome is change in the delayed recall score from baseline to 6 months.
|
baseline and 6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: David Sparrow, DSc, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2545-P
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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