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Trial record 25 of 145 for:    Recruiting, Not yet recruiting, Available Studies | "Drinking Water"

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

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ClinicalTrials.gov Identifier: NCT02614092
Recruitment Status : Recruiting
First Posted : November 25, 2015
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: Water-based Activity + Cognitive Training Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Water-based Activities to Enhance Recall in Veterans (WATER-VET)
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: Water based Activity+ Cognitive Training
water-based physical activity + classroom based cognitive training
Behavioral: Water-based Activity + Cognitive Training
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 Measures :
  1. Retention and Recruitment Rates [ Time Frame: Through Study Completion, an average of 8 months ]
    Feasibility will be demonstrated through ratio of enrolled to completed participants


Secondary Outcome Measures :
  1. Change in Delayed Recall of a Word List [ Time Frame: Through Study Completion, an average of 8 months ]
    Change From Baseline on the Delayed Recall of a Word List at 8 months

  2. Participant Adherence to Protocol [ Time Frame: Through Study Completion, an average of 8 months ]
    Participant completion of study related measurements including pedometers, activity logs, cognitive training homework

  3. Appropriateness of Inclusion and Exclusion Criteria [ Time Frame: Through Study Completion, an average of 8 months ]
    Number of participants reported adverse events and most frequent reasons for screen failures



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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614092


Contacts
Contact: Heather L Taylor, MS (650) 493-5000 ext 68957 Heather.Taylor4@va.gov

Locations
United States, California
VA Palo Alto Health Care System, Palo Alto, CA Recruiting
Palo Alto, California, United States, 94304-1290
Contact: Jennifer K Fairchild, PhD    (650) 439-5000 ext 63432    JenniferKaci.Fairchild@va.gov   
Principal Investigator: Jennifer Kaci Fairchild, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Jennifer Kaci Fairchild, PhD VA Palo Alto Health Care System, Palo Alto, CA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02614092     History of Changes
Other Study ID Numbers: E1884-P
12I1-RX001884-01A1 ( Other Grant/Funding Number: Department of Veterans Affairs RRD )
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by VA Office of Research and Development:
Mild Cognitive Impairment
memory impairment
Physical Activity
Exercise
Cognitive Training
Veterans
Older Adults

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders