NCT04296565CompletedPhase 4
Water-based Activity to Enhance Recall in Veterans: A Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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 Cognitive Impairment (aMCI). This is a two-phased trial: 1) an exercise phase and 2) a cognitive training program. The exercise phase will be an aquatic based exercise program. A combination of exercise and cognitive training programs designed for persons without cognitive impairment have significantly improved memory more than other single intervention groups (exercise only, cognitive training only) and given the success of combination training programs with healthy older adults, it is important to adapt these programs for persons beginning to exhibit clinically significant memory problems, such as those with aMCI.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 121 (actual)
- First submitted
- 2 Mar 2020
- Start date
- 3 Jan 2022
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Alzheimer disease
- NCT number
- NCT04296565
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 121
- From 3 Jan 2022 to the primary completion date, 31 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Lab values
- 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)
Other
- Inability to participate in an exercise stress test
- Inability to read, verbalize understanding and voluntarily sign the Informed Consent
Who the study is looking for
- Veterans 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
Age in the registry: 50 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.