Water-based Activity to Enhance Recall in Veterans

Mild Cognitive Impairment Clinical Trial

— WATER-VET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02614092
• Other study ID #: E1884-P
• Secondary ID: 12I1-RX001884-01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: November 30, 2020

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: November 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention and Recruitment Rates	Feasibility will be demonstrated through ratio of enrolled to completed participants	Through Study Completion, an average of 8 months
Secondary	Change in Delayed Recall of a Word List	Change From Baseline on the Delayed Recall of a Word List at 8 months	Through Study Completion, an average of 8 months
Secondary	Participant Adherence to Protocol	Participant completion of study related measurements including pedometers, activity logs, cognitive training homework	Through Study Completion, an average of 8 months
Secondary	Appropriateness of Inclusion and Exclusion Criteria	Number of reported serious and non-serious adverse events reported by participants who were eligible for study participation.	From time of consent until completion of Time 3 assessments, an average of 8 months