A Combined Training Program for Veterans With Amnestic Mild Cognitive Impairment

April 3, 2018 updated by: J. Kaci Fairchild, PhD, Palo Alto Veterans Institute for Research
The purpose of this study is examine the efficacy of a combination physical exercise and cognitive training program on improving memory in older Veterans with amnestic Mild Cognitive Impairment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • VA Palo Alto Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of amnestic Mild Cognitive Impairment
  • available informant
  • visual and auditory acuity to allow neuropsychological testing
  • willingness to participate in exercise training + cognitive training for 8 months
  • approval of primary provider to participate in exercise trial

Exclusion Criteria:

  • current severe psychiatric disorder
  • diagnosis of dementia
  • history of neurological or system illness affecting CNS function
  • acute illness or unstable chronic illness
  • current severe cardiac disease
  • inability to exercise consistently because of orthopedic or musculoskeletal problems
  • morbid obesity
  • inability to read, verbalize understanding and voluntarily sign the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Combined Aerobic and Resistance Exercise/Cognitive Training
Behavioral: Combined Aerobic and Resistance Exercise
Gym and home based aerobic and resistance exercises
Behavioral: Cognitive Training
Group-based cognitive training
Active Comparator: Stretching Exercises/Cognitive Training
Behavioral: Cognitive Training
Group-based cognitive training
Behavioral: Stretching Exercises
Gym and home based stretching exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline to 28 weeks in delayed recall of a word list
Time Frame: Baseline, 24 weeks, 28 weeks
Baseline, 24 weeks, 28 weeks
Change from Baseline to 28 weeks in Delayed Recall of Names-Face Task
Time Frame: Baseline, 24 weeks, 28 weeks
Baseline, 24 weeks, 28 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Non-Cognitive Outcomes (Depression, Sleep, Quality of Life)
Time Frame: Baseline, Time 2, Time 3
Baseline, Time 2, Time 3

Other Outcome Measures

Outcome Measure
Time Frame
Exercise Assessment
Time Frame: Baseline, Time 2, and Time 3
Baseline, Time 2, and Time 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Palo Alto Veterans Institute for Research

Collaborators

U.S. Army Medical Research and Development Command

Investigators

  • Principal Investigator: Jennifer K Fairchild, PhD, VA Palo Alto Health Care System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

August 26, 2013

First Submitted That Met QC Criteria

October 9, 2013

First Posted (Estimate)

October 14, 2013

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAI0002AGG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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