Water-based Activity to Enhance Recall in Veterans

NCT04296565 | Active Not Recruiting Phase 4

• 2 other identifiers: E3143-R1I01RX003143-01A2
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; Cognition; Alzheimer's Disease; Physical Exercise; Cognitive Training

Outcome Measures

Primary Outcomes (1)

• Cognitive Function Composite Score (ADAS-Cog-Exe)

  The ADAS-Cog is a structured scale that evaluates multiple cognitive domains including: orientation, memory, reasoning, language, and praxis.

  8 months

Secondary Outcomes (1)

• Peak VO2

  8 months

Study Arms (2)

Usual Care

OTHER

Usual Care condition involves receipt of educational materials about brain health and healthy lifestyles as well as regular contact with study staff.

Behavioral: Usual Care

WATER+CT

EXPERIMENTAL

This is an 8 month long two phase intervention. The first phase consists of 6 months of thrice weekly pool based physical activity occurring at the Palo Alto VA Health Care System. After completion of the 6 month long water based physical activity, participants transition to a ten session cognitive training program at the Palo Alto VA. The cognitive training classes are approximately two hours in length and will be spread over ten sessions across 4 weeks.

Behavioral: WATER+CT

Interventions

Usual Care BEHAVIORAL

Usual Care condition involves receipt of educational materials about brain health and healthy lifestyles as well as regular contact with study staff

Usual Care

WATER+CT BEHAVIORAL

This is an 8 month long two phase intervention. The first phase consists of 6 months of thrice weekly pool based physical activity occurring at the Palo Alto VA Health Care System. After completion of the 6 month long water based physical activity, participants transition to a ten session cognitive training program at the Palo Alto VA. The cognitive training classes are approximately two hours in length and will be spread over ten sessions across 4 weeks.

WATER+CT

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Motor Activity

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Behavior

Study Officials

• Jennifer Kaci Fairchild, PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 5, 2020
• Study Start: January 3, 2022
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)