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A Combined Training Program for Veterans With Amnestic Mild Cognitive Impairment

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
J. Kaci Fairchild, PhD, Palo Alto Veterans Institute for Research
ClinicalTrials.gov Identifier:
NCT01962038
First received: August 26, 2013
Last updated: April 3, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Amnestic Mild Cognitive Impairment
Behavioral: Combined Aerobic and Resistance Exercise
Behavioral: Stretching Exercises
Behavioral: Cognitive Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Combined Training Program for Veterans With Amnestic Mild Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by Palo Alto Veterans Institute for Research:

Primary Outcome Measures:
  • Change from Baseline to 28 weeks in delayed recall of a word list [ Time Frame: 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 ]

Secondary Outcome Measures:
  • Non-Cognitive Outcomes (Depression, Sleep, Quality of Life) [ Time Frame: Baseline, Time 2, Time 3 ]

Other Outcome Measures:
  • Exercise Assessment [ Time Frame: Baseline, Time 2, and Time 3 ]

Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Stretching Exercises
Gym and home based stretching exercises
Behavioral: Cognitive Training
Group-based cognitive training

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01962038

Locations
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Palo Alto Veterans Institute for Research
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Jennifer K Fairchild, PhD VA Palo Alto Health Care System
  More Information

Responsible Party: J. Kaci Fairchild, PhD, Clinical Psychologist, Palo Alto Veterans Institute for Research
ClinicalTrials.gov Identifier: NCT01962038     History of Changes
Other Study ID Numbers: FAI0002AGG
Study First Received: August 26, 2013
Last Updated: April 3, 2017

Keywords provided by Palo Alto Veterans Institute for Research:
Mild Cognitive Impairment
Aging

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2017