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Clinical Trials/NCT03824639
NCT03824639
Completed
N/A

Exercise Training to Improve Cognitive Function

VA Office of Research and Development1 site in 1 country60 target enrollmentApril 23, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
VA Office of Research and Development
Enrollment
60
Locations
1
Primary Endpoint
Change in Delayed Recall Score on Wechsler Logical Memory Task From Baseline to 6 Months
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This project is assessing the feasibility of a novel home-based exercise intervention to improve episodic memory in individuals with mild cognitive impairment.

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.

Registry
clinicaltrials.gov
Start Date
April 23, 2019
End Date
July 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change in Delayed Recall Score on the Rey-Osterrieth Complex Figure Test From Baseline to 6 Months(baseline and 6 months)

Study Sites (1)

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