Status:
ACTIVE_NOT_RECRUITING
Water-based Activity to Enhance Recall in Veterans
Lead Sponsor:
VA Office of Research and Development
Conditions:
Mild Cognitive Impairment
Eligibility:
All Genders
50-90 years
Phase:
PHASE4
Brief Summary
This four-year study will evaluate the efficacy of an exercise training augmentation for cognitive training intervention to improve memory performance in Veterans with a diagnosis of amnestic Mild Cog...
Detailed Description
The primary research question of the proposed study is this: Is a water-based exercise plus cognitive training intervention efficacious in improving cognitive outcomes for Veterans with Mild Cognitive...
Eligibility Criteria
Inclusion
- Veterans, aged 50 to 90, of any racial or ethnic group
- Diagnosis of single or multi-domain amnestic MCI using criteria per National Institute on Aging/Alzheimer's Association Guidelines
- Available informant for completion of the Clinical Dementia Rating Scale
- Visual and auditory acuity to allow neuropsychological testing
- Willingness to participate in clinical trial for 14 months (8-month treatment phase, 6-month no-contact follow-up phase)
- Musculoskeletal illness or injury (i.e., osteoporosis, degenerative disc or joint disease, arthritis, obesity)
- Approval by Primary Care Provider to participate in water-based physical exercise
Exclusion
- Psychiatric Exclusions
- Current, uncontrolled severe psychiatric disorder, such as Bipolar I, Schizophrenia, or Major Depressive Disorder as determined by the Mini International Neuropsychiatric Interview (MINI)
- Diagnosis of dementia, Clinical Dementia Rating Scale (CDR) \> 0.5; modified Hachinksi score 4; or delirium. Those Veterans with scores indicative of dementia (CDR \> 0.5, modified Hachinksi 4) will be referred to the Memory Disorders Clinic at VAPAHCS for a full diagnostic work-up
- Medical Exclusions
- History of neurological (e.g., multiple sclerosis, seizure disorder, stroke,) or system illness affecting CNS function (e.g., liver failure, kidney failure, congestive heart failure, systemic cancer)
- Acute illness or unstable chronic illness, e.g., history of severe liver disease (cirrhosis, esophageal varices, ascites, portal hypertension, hepatic encephalopathy)
- Current severe cardiac disease (e.g., uncontrolled atrial fibrillation, defined as mean 24 hour heart rate \>85 beats/min, or 24 hour maximal ventricular rate \>150 beats/min; uncontrolled ventricular arrhythmias, defined as recurrent ventricular tachycardia \>3 beats in succession, or 24 hour PVC count \>20%; active pericarditis or myocarditis; Class III/IV heart failure and / or ejection fraction \< 20%; thrombophlebitis; pulmonary disease with a drop in O2 Sat with exercise to 90% without oxygen; embolism within past 6 months)
- Inability to participate in an exercise stress test
- Inability to read, verbalize understanding and voluntarily sign the Informed Consent
Key Trial Info
Start Date :
January 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT04296565
Start Date
January 3 2022
End Date
June 30 2026
Last Update
August 17 2025
Active Locations (1)
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1
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1207