Mild Cognitive ImpairmentWATER-VETNCT02614092
Water-based Activity to Enhance Recall in Veterans
A study testing Water-based Activity + Cognitive Training in people with Mild Cognitive Impairment, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Water-based Activity + Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.:
Show all 32Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
About this study
Official title: Water-based Activities to Enhance Recall in Veterans (WATER-VET)
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Water-based Activity + Cognitive Training
- Keywords
- Mild Cognitive Impairment, memory impairment, Physical Activity, Exercise, Cognitive Training, Veterans, Older Adults
- Medical subject headings
- Cognitive Dysfunction, Memory Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water-based Activity + Cognitive TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Water based Activity+ Cognitive Training | Experimental | water-based physical activity + classroom based cognitive training Receives: Behavioral: Water-based Activity + Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention and Recruitment Rates
Feasibility will be demonstrated through ratio of enrolled to completed participants
Measured: Through Study Completion, an average of 8 months
Secondary outcomes (3)
Change in Delayed Recall of a Word List
Change From Baseline on the Delayed Recall of a Word List at 8 months
Measured: Through Study Completion, an average of 8 months
Participant Adherence to Protocol
Participant completion of study related measurements including pedometers, activity logs, cognitive training homework
Measured: Through Study Completion, an average of 8 months
Appropriateness of Inclusion and Exclusion Criteria
Number of reported serious and non-serious adverse events reported by participants who were eligible for study participation.
Measured: From time of consent until completion of Time 3 assessments, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study start1 Jan 2016
- Primary completion30 Apr 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jennifer Kaci Fairchild, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614092
- Sponsor's protocol ID
- E1884-P
- Other IDs
- 12I1-RX001884-01A1
- Acronym
- WATER-VET
- Status last verified
- Apr 2024
- First submitted
- 23 Nov 2015
- Last updated
- 17 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water-based Activities to Enhance Recall in Veterans (WATER-VET)
- ClinicalTrials.gov ID
- NCT02614092
- Acronym / sponsor ID
- WATER-VET / E1884-P
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, memory impairment, Physical Activity, Exercise, Cognitive Training, Veterans, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Posted 17 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Water based Activity+ Cognitive Training | Experimental | Behavioral: Water-based Activity + Cognitive Trainingwater-based physical activity + classroom based cognitive training |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Veterans aged 50 - 90
- diagnosis of aMCI
- available informant
- at least one musculoskeletal problem
- sufficient visual and auditory acuity to allow neuropsychological testing
Key exclusion criteria (32 listed)
- current untreated severe psychiatric disorder, such as:
- diagnosis of dementia, Clinical Dementia Rating (CDR) > 0.5; modified Hachinski score 4; or delirium
- history of neurological disorder, e.g.:
- history of transient ischemic attacks, or systemic illness affecting central nervous system (CNS) function, e.g.:
- acute illness or unstable chronic illness e.g., history of severe liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water-based Activity + Cognitive TrainingThis 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. | Behavioural | Water based Activity+ Cognitive Training |
Primary outcome
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
3 secondary outcomes
Change in Delayed Recall of a Word List
Time frame: Through Study Completion, an average of 8 months
Participant Adherence to Protocol
Time frame: Through Study Completion, an average of 8 months
Appropriateness of Inclusion and Exclusion Criteria
Time frame: From time of consent until completion of Time 3 assessments, an average of 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Kaci Fairchild, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water-based Activity + Cognitive Training in people with Mild Cognitive Impairment, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention and Recruitment Rates (time frame: Through Study Completion, an average of 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.