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Exercise Training to Improve Cognitive Function

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ClinicalTrials.gov Identifier: NCT03824639
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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
Mild Cognitive Impairment 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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 23, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Wechsler Logical Memory Task [ Time Frame: 6 months ]
    A recall test involving 2 short stories


Secondary Outcome Measures :
  1. Rey-Osterrieth Complex Figure Test [ Time Frame: 6 months ]
    A recall test involving a complex figure



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824639


Contacts
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Contact: David W Sparrow, DSc (857) 364-6400 ext 46400 David.Sparrow@va.gov

Locations
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United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Recruiting
Boston, Massachusetts, United States, 02130
Contact: David W Sparrow, DSc    (857) 364-6400 ext 46400    David.Sparrow@va.gov   
Principal Investigator: David William Sparrow, DSc         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: David William Sparrow, DSc VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03824639     History of Changes
Other Study ID Numbers: E2545-P
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Mild cognitive impairment
exercise therapy
patient adherence

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders