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Exercise Training to Improve Cognitive Function

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VA Office of Research and Development

Status

Completed

Conditions

Mild Cognitive Impairment

Treatments

Behavioral: Health Education
Behavioral: Structured exercise

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT03824639
E2545-P

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Exercise group
Experimental group
Description:
Structured exercise
Treatment:
Behavioral: Structured exercise
Control group
Active Comparator group
Description:
Health education
Treatment:
Behavioral: Health Education

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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