A Combined Training Program for Veterans With Amnestic Mild Cognitive Impairment

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Palo Alto Institute for Research and Education, Inc
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Palo Alto Institute for Research and Education, Inc
ClinicalTrials.gov Identifier:
NCT01962038
First received: August 26, 2013
Last updated: December 9, 2013
Last verified: December 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 Institute for Research and Education, Inc:

Primary Outcome Measures:
  • Change from Baseline to 28 weeks in delayed recall of a word list [ Time Frame: Baseline, 24 weeks, 28 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to 28 weeks in Delayed Recall of Names-Face Task [ Time Frame: Baseline, 24 weeks, 28 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Non-Cognitive Outcomes (Depression, Sleep, Quality of Life) [ Time Frame: Baseline, Time 2, Time 3 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Exercise Assessment [ Time Frame: Baseline, Time 2, and Time 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Primary Completion Date: September 2014 (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
Genders Eligible for Study:   Both
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

Contacts
Contact: Janet Zamudio, M.A. 650-493-5000 ext 65992 janet.zamudio@va.gov
Contact: Sunny Atchison, M.A. 650-493-5000 ext 69832 sunny.atchison@va.gov

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

No publications provided

Responsible Party: Palo Alto Institute for Research and Education, Inc
ClinicalTrials.gov Identifier: NCT01962038     History of Changes
Other Study ID Numbers: FAI0002AGG
Study First Received: August 26, 2013
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Palo Alto Institute for Research and Education, Inc:
Mild Cognitive Impairment
Aging

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014