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
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment||Behavioral: Water-based Activity + Cognitive Training||Not Applicable|
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)|
|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|
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.
- 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
- 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
- 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
- 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
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
|Contact: Heather L Taylor, MS||(650) 493-5000 ext 68957||Heather.Taylor4@va.gov|
|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|
|Principal Investigator:||Jennifer Kaci Fairchild, PhD||VA Palo Alto Health Care System, Palo Alto, CA|