search
Back to results

Exercise Training to Improve Cognitive Function

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Structured exercise
Health Education
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mild Cognitive Impairment focused on measuring Mild cognitive impairment, exercise therapy, patient adherence

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise group

Control group

Arm Description

Structured exercise

Health education

Outcomes

Primary Outcome Measures

Wechsler Logical Memory Task
A recall test involving 2 short stories

Secondary Outcome Measures

Rey-Osterrieth Complex Figure Test
A recall test involving a complex figure

Full Information

First Posted
January 29, 2019
Last Updated
August 18, 2022
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT03824639
Brief Title
Exercise Training to Improve Cognitive Function
Official Title
Exercise Training to Improve Cognitive Function
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 23, 2019 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild cognitive impairment, exercise therapy, patient adherence

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Description
Structured exercise
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Health education
Intervention Type
Behavioral
Intervention Name(s)
Structured exercise
Intervention Description
Exercise instruction and encouragement
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Provision of general information about a variety of health topics
Primary Outcome Measure Information:
Title
Wechsler Logical Memory Task
Description
A recall test involving 2 short stories
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Rey-Osterrieth Complex Figure Test
Description
A recall test involving a complex figure
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David William Sparrow, DSc
Organizational Affiliation
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Exercise Training to Improve Cognitive Function

We'll reach out to this number within 24 hrs