Exercise Training to Improve Cognitive Function

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT03824639
Collaborator
(none)
60
1
2
39.3
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Structured exercise
  • Behavioral: Health Education
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Exercise Training to Improve Cognitive Function
Actual Study Start Date :
Apr 23, 2019
Actual Primary Completion Date :
May 31, 2022
Actual Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exercise group

Structured exercise

Behavioral: Structured exercise
Exercise instruction and encouragement

Active Comparator: Control group

Health education

Behavioral: Health Education
Provision of general information about a variety of health topics

Outcome Measures

Primary Outcome Measures

  1. Wechsler Logical Memory Task [6 months]

    A recall test involving 2 short stories

Secondary Outcome Measures

  1. Rey-Osterrieth Complex Figure Test [6 months]

    A recall test involving a complex figure

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Boston Massachusetts United States 02130

Sponsors and Collaborators

  • VA Office of Research and Development

Investigators

  • Principal Investigator: David William Sparrow, DSc, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT03824639
Other Study ID Numbers:
  • E2545-P
First Posted:
Jan 31, 2019
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by VA Office of Research and Development
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2022