Water-based Activity to Enhance Recall in Veterans

NCT02614092 | Completed Results

• 2 other identifiers: E1884-P12I1-RX001884-01A1
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; memory impairment; Physical Activity; Exercise; Cognitive Training; Veterans; Older Adults

Outcome Measures

Primary Outcomes (1)

• Retention and Recruitment Rates

  Feasibility will be demonstrated through ratio of enrolled to completed participants

  Through Study Completion, an average of 8 months

Secondary Outcomes (3)

• Change in Delayed Recall of a Word List

  Through Study Completion, an average of 8 months

• Participant Adherence to Protocol

  Through Study Completion, an average of 8 months

• Appropriateness of Inclusion and Exclusion Criteria

  From time of consent until completion of Time 3 assessments, an average of 8 months

Study Arms (1)

Water based Activity+ Cognitive Training

EXPERIMENTAL

water-based physical activity + classroom based cognitive training

Behavioral: Water-based Activity + Cognitive Training

Interventions

Water-based Activity + Cognitive Training 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 based Activity+ Cognitive Training

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Memory Disorders; Motor Activity

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

The final participant completed cognitive training in a remote environment due to COVID19 shelter-in-place orders.

Results Point of Contact

• Title: Dr. Kaci Fairchild
• Organization: VISN 21 MIRECC, VA Palo Alto Health Care System

jenniferkaci.fairchild@va.gov

6504935000

Study Officials

• Jennifer Kaci Fairchild, PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: November 25, 2015
• Study Start: January 1, 2016
• Primary Completion: April 30, 2020
• Study Completion: November 30, 2020
• Last Updated: April 17, 2024
• Results First Posted: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)