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Water-based Activity to Enhance Recall in Veterans (WATER-VET)

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Water-based Activity + Cognitive Training
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, memory impairment, Physical Activity, Exercise, Cognitive Training, Veterans, Older Adults

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 < 20%
    • thrombophlebitis
    • pulmonary disease with a drop in O2 Sat with exercise to 90% without oxygen
    • embolism within past six months
  • inability to participate in an exercise stress test or inability to exercise consistently because of orthopedic or musculoskeletal problems
  • morbid obesity (BMI > 39)
  • inability to read, verbalize understanding and voluntarily sign the Informed Consent

Sites / Locations

  • VA Palo Alto Health Care System, Palo Alto, CA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Water based Activity+ Cognitive Training

Arm Description

water-based physical activity + classroom based cognitive training

Outcomes

Primary Outcome Measures

Retention and Recruitment Rates
Feasibility will be demonstrated through ratio of enrolled to completed participants

Secondary Outcome Measures

Change in Delayed Recall of a Word List
Change From Baseline on the Delayed Recall of a Word List at 8 months
Participant Adherence to Protocol
Participant completion of study related measurements including pedometers, activity logs, cognitive training homework
Appropriateness of Inclusion and Exclusion Criteria
Number of participants reported adverse events and most frequent reasons for screen failures

Full Information

First Posted
November 23, 2015
Last Updated
February 24, 2021
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02614092
Brief Title
Water-based Activity to Enhance Recall in Veterans
Acronym
WATER-VET
Official Title
Water-based Activities to Enhance Recall in Veterans (WATER-VET)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The primary research question of the proposed study is this: Is a combination water-based physical exercise + cognitive training program for older Veterans with amnestic Mild Cognitive Impairment (MCI) feasible? The primary aims of the proposed research are: 1) demonstrate adequate recruitment and retention rates; 2) refinement of inclusion/exclusion criteria; and 3) further refine the combination waterbased physical exercise + cognitive training (WATER+CT) intervention. These aims will be tested in a two-phase clinical trial with a single group design: 1) exercise training phase and 2) a cognitive training phase. The exercise training phase consists of a water-based physical exercise program that emphasizes cardiovascular fitness and strength training through a combination of non-weight bearing exercises that include land-based stretching and water-based activities. This 2-year pilot project will include 50 Veterans diagnosed with amnestic MCI age 50-90. The exercise component consists of a six-month water-based exercise program followed by a four-week cognitive training program. For the first two months of the water-based exercise program, Veterans will come to thrice-weekly group sessions at Aquatic Therapy Center at the VA Palo Alto Health Care System. This will transition to a self-paced exercise program for the remaining four months. After completion of the exercise program, Veterans will begin classroom-based cognitive training at the VA Palo Alto Health Care System (VAPAHCS). The cognitive training is based on an efficacious cognitive program that is structured around two components, pre-training and mnemonic training, both of which have been used successfully in persons with aMCI. Assessments of adherence will be administered throughout treatment and measures of feasibility will be completed post-treatment. Participants will complete a variety of neuropsychological measures taping into areas of cognition such as attention, executive functioning, and memory. To study possible predictors of treatment response, the investigators will also collect biological (cardiovascular functioning and brain derived neurotrophic factor [BDNF] plasma levels) and genetic data (APOE and BDNF genotypes) from these participants. The investigators hope to provide initial evidence of the feasibility of a waterbased exercise training augmentation for cognitive training thus laying the groundwork for full-scale clinical trials targeting the lessening of cognitive impairment in persons with amnestic MCI by non-pharmacological means.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment, memory impairment, Physical Activity, Exercise, Cognitive Training, Veterans, Older Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Water based Activity+ Cognitive Training
Arm Type
Experimental
Arm Description
water-based physical activity + classroom based cognitive training
Intervention Type
Behavioral
Intervention Name(s)
Water-based Activity + Cognitive Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Retention and Recruitment Rates
Description
Feasibility will be demonstrated through ratio of enrolled to completed participants
Time Frame
Through Study Completion, an average of 8 months
Secondary Outcome Measure Information:
Title
Change in Delayed Recall of a Word List
Description
Change From Baseline on the Delayed Recall of a Word List at 8 months
Time Frame
Through Study Completion, an average of 8 months
Title
Participant Adherence to Protocol
Description
Participant completion of study related measurements including pedometers, activity logs, cognitive training homework
Time Frame
Through Study Completion, an average of 8 months
Title
Appropriateness of Inclusion and Exclusion Criteria
Description
Number of participants reported adverse events and most frequent reasons for screen failures
Time Frame
Through Study Completion, an average of 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 < 20% thrombophlebitis pulmonary disease with a drop in O2 Sat with exercise to 90% without oxygen embolism within past six months inability to participate in an exercise stress test or inability to exercise consistently because of orthopedic or musculoskeletal problems morbid obesity (BMI > 39) inability to read, verbalize understanding and voluntarily sign the Informed Consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Kaci Fairchild, PhD
Organizational Affiliation
VA Palo Alto Health Care System, Palo Alto, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Water-based Activity to Enhance Recall in Veterans

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