Back to resultsA Combined Training Program for Veterans With Amnestic Mild Cognitive Impairment
Primary Purpose
Amnestic Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Combined Aerobic and Resistance Exercise
Stretching Exercises
Cognitive Training
Sponsored by
About this trial
This is an interventional treatment trial for Amnestic Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, Aging
Eligibility 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
Sites / Locations
- VA Palo Alto Health Care System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Combined Aerobic and Resistance Exercise/Cognitive Training
Stretching Exercises/Cognitive Training
Arm Description
Outcomes
Primary Outcome Measures
Change from Baseline to 28 weeks in delayed recall of a word list
Change from Baseline to 28 weeks in Delayed Recall of Names-Face Task
Secondary Outcome Measures
Non-Cognitive Outcomes (Depression, Sleep, Quality of Life)
Full Information
NCT ID
NCT01962038
First Posted
August 26, 2013
Last Updated
April 3, 2018
Sponsor
Palo Alto Veterans Institute for Research
Collaborators
U.S. Army Medical Research and Development Command
1. Study Identification
Unique Protocol Identification Number
NCT01962038
Brief Title
A Combined Training Program for Veterans With Amnestic Mild Cognitive Impairment
Official Title
A Combined Training Program for Veterans With Amnestic Mild Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Palo Alto Veterans Institute for Research
Collaborators
U.S. Army Medical Research and Development Command
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amnestic Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment, Aging
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combined Aerobic and Resistance Exercise/Cognitive Training
Arm Type
Active Comparator
Arm Title
Stretching Exercises/Cognitive Training
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Combined Aerobic and Resistance Exercise
Intervention Description
Gym and home based aerobic and resistance exercises
Intervention Type
Behavioral
Intervention Name(s)
Stretching Exercises
Intervention Description
Gym and home based stretching exercises
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
Group-based cognitive training
Primary Outcome Measure Information:
Title
Change from Baseline to 28 weeks in delayed recall of a word list
Time Frame
Baseline, 24 weeks, 28 weeks
Title
Change from Baseline to 28 weeks in Delayed Recall of Names-Face Task
Time Frame
Baseline, 24 weeks, 28 weeks
Secondary Outcome Measure Information:
Title
Non-Cognitive Outcomes (Depression, Sleep, Quality of Life)
Time Frame
Baseline, Time 2, Time 3
Other Pre-specified Outcome Measures:
Title
Exercise Assessment
Time Frame
Baseline, Time 2, and Time 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer K Fairchild, PhD
Organizational Affiliation
VA Palo Alto Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Combined Training Program for Veterans With Amnestic Mild Cognitive Impairment
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