N/A
N=101
Water-based Activity to Enhance Recall in Veterans
Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT02614092 ↗Enrolled (actual)
101
Serious AEs
9.7%
Results posted
Apr 2024
Primary outcome: Primary: Retention and Recruitment Rates — 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Water-based Activity + Cognitive Training (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention and Recruitment Rates |
21 | — |
| SECONDARY Change in Delayed Recall of a Word List |
3.94 | — |
| SECONDARY Participant Adherence to Protocol |
63.5 | — |
| SECONDARY Appropriateness of Inclusion and Exclusion Criteria |
10 | — |
Summary
This two-year study will evaluate the feasibility 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.
Eligibility Criteria
Inclusion Criteria
- Veterans aged 50 - 90
- diagnosis of aMCI
- available informant
- at least one musculoskeletal problem
- sufficient visual and auditory acuity to allow neuropsychological testing
- willingness to participate in exercise training +cognitive training program for eight months
- approval of primary provider to participate in an exercise trial
Exclusion Criteria
- current untreated severe psychiatric disorder, such as:
- Bipolar I
- Schizophrenia
- or Major Depressive Disorder, determined by the Mini International Neuropsychiatric Interview (MINI)
- diagnosis of dementia, Clinical Dementia Rating (CDR) > 0.5; modified Hachinski score 4; or delirium
- history of neurological disorder, e.g.:
- multiple sclerosis
- seizure disorder
- stroke
- history of transient ischemic attacks, or systemic illness affecting central nervous system (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 packed cell volume (PVC) count > 20%; active
- pericarditis or myocarditis
- Class III/IV heart failure and / or ejection fraction 39)
- inability to read, verbalize understanding and voluntarily sign the Informed Consent
Data sourced from ClinicalTrials.gov (NCT02614092). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.