Water-Based Exercise + Cognitive Training for Mild Cognitive Impairment

(WATER-Vet Trial)

Overseen By Jennifer K Fairchild, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: VA Office of Research and Development

Disqualifiers: Bipolar, Schizophrenia, Dementia, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining water-based exercise with cognitive training, known as WATER+CT, can improve memory in veterans with mild memory problems, specifically amnestic Mild Cognitive Impairment (aMCI). The trial will last eight months and include two main parts: six months of pool exercises followed by a month of cognitive training sessions. Veterans diagnosed with aMCI who can participate in water exercises might be suitable candidates for this study. As a Phase 4 trial, it involves an FDA-approved treatment and focuses on understanding how it can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for the WATER+CT treatment?

Studies have shown that exercise programs in water are generally easy for participants to handle. Research indicates that similar programs have been safely used with older adults, even those with mild memory problems. Most people experience some muscle soreness, which is normal with any new exercise. Serious side effects rarely occur.

The mental training component has also been studied and is considered safe. It includes exercises to help improve memory and thinking skills. Participants usually find these sessions engaging and report few negative effects.

This trial is in a more advanced stage, meaning earlier studies have already demonstrated the treatments' safety. This suggests that both the water exercise and mental training are expected to be safe for most people. As always, discussing any health concerns with a doctor before joining is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the WATER+CT treatment for mild cognitive impairment because it combines water-based exercise with cognitive training, offering a holistic approach that's different from traditional treatments. While most current options primarily focus on medications or mental exercises alone, this treatment integrates physical activity in water, which can be gentler on the body and improve overall brain function. Additionally, the cognitive training component is designed to enhance mental agility, making it a comprehensive option for tackling cognitive challenges from multiple angles.

What evidence suggests that the WATER+CT program could be effective for improving memory in Veterans with aMCI?

This trial will compare the effects of usual care with a combined water-based exercise and cognitive training program, known as WATER+CT, for individuals with mild cognitive impairment (MCI). Research has shown that combining water-based exercise with brain training can greatly improve memory in people with mild memory problems. One study found that a short program of water exercises improved both physical fitness and mental skills like focus and decision-making. Earlier studies also discovered that combining exercise and brain training enhances memory more than either activity alone. This combined approach has been successful for healthy older adults, and adapting it for those with memory issues appears promising. This method has improved memory in other contexts, suggesting it could also benefit people with memory problems like amnestic MCI. ^{2 3 4 6 7}

Who Is on the Research Team?

Jennifer Kaci Fairchild, PhD

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Are You a Good Fit for This Trial?

Veterans aged 50-90 with mild cognitive impairment (aMCI) who can undergo neuropsychological testing and are approved for water-based exercise by their primary care provider. They need an informant for clinical assessments and must commit to a 14-month trial period. Excluded are those with severe psychiatric disorders, dementia, unstable chronic illnesses, or conditions affecting central nervous system function.

Inclusion Criteria

I am a veteran aged between 50 and 90.

I can see and hear well enough to take psychological tests.

I have been diagnosed with mild cognitive impairment as per national guidelines.

Exclusion Criteria

I do not have an uncontrolled severe psychiatric disorder.

I do not have severe heart problems or recent serious blood clots.

I have been diagnosed with dementia or have symptoms of it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Phase

Participants engage in a water-based exercise program for six months, attending thrice-weekly group sessions at the Aquatic Therapy Center.

6 months

Thrice-weekly group sessions

Cognitive Training Phase

Participants undergo classroom-based cognitive training, consisting of ten sessions over four weeks.

4 weeks

10 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a final follow-up visit at the VA.

6 months

Final follow-up visit

What Are the Treatments Tested in This Trial?

Interventions

• Usual Care
• WATER+CT

Trial Overview The study is examining the effectiveness of combining aquatic exercises with cognitive training to improve memory in veterans with aMCI. Participants will first engage in water-based physical activities followed by a program designed to enhance cognitive functions over an eight-month treatment phase.

How Is the Trial Designed?

Group I: WATER+CT Experimental Treatment 1 Intervention

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.

Group II: Usual Care Experimental Treatment 1 Intervention

Usual Care condition involves receipt of educational materials about brain health and healthy lifestyles as well as regular contact with study staff.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a study of 87 patients with Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD) over 6 months, cognitive and physical activity treatments (CT and PT) were found to effectively mitigate cognitive decline, as patients in the control group showed significant deterioration.

While both CT and PT did not show significant differences in improving global cognitive function, they helped maintain cognitive abilities in MCI and AD patients, with PT also improving cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between physical and cognitive treatment in patients with MCI and Alzheimer's disease. Fonte, C., Smania, N., Pedrinolla, A., et al.[2020]

A 16-week water-based aerobic training program significantly improved functional capacity and reduced blood pressure in older women, with improvements ranging from 3-11% in functional capacity and 4-10 mmHg in blood pressure.

Cognitive function did not show any significant changes across all groups, indicating that while physical training is beneficial for functional and hemodynamic responses, it may not impact cognitive abilities in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Water-Based Training Programs Improve Functional Capacity, Cognitive and Hemodynamic Outcomes? The ACTIVE Randomized Clinical Trial. Häfele, MS., Alberton, CL., Häfele, V., et al.[2023]

A study involving 67 older adults with mild cognitive impairment (MCI) showed that both water-based and land-based exercise combined with cognitive training significantly improved learning and memory outcomes over 6 months.

However, improvements in executive functioning, processing speed, language, and visuospatial abilities were only observed in the water-based exercise group, suggesting that aquatic activities may offer additional cognitive benefits for older adults with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Improvement Following Physical Exercise and Cognitive Training Intervention for Older Adults With MCI. Campbell, EB., Delgadillo, M., Lazzeroni, LC., et al.[2023]

A brief, six-day water-based exercise program significantly improved cardiovascular fitness and cognitive functions, including executive function, attention, and memory, in older adults compared to a control group.

The study involved 60 community-dwelling older adults, with the exercise group attending daily moderate-intensity water aerobics, highlighting that even short-term exercise can have meaningful benefits for cognitive health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a brief, water-based exercise intervention on cognitive function in older adults. Fedor, A., Garcia, S., Gunstad, J.[2015]

A 12-month structured exercise program did not lead to significant improvements in cognitive performance for individuals with mild cognitive impairment (MCI) compared to a non-exercise control group, based on a study of 183 participants.

However, the exercise intervention did result in improved physical fitness, as indicated by higher VO2 peak levels in the exercise groups, suggesting that while cognitive benefits were not observed, enhanced physical fitness may play a role in long-term disease progression and should be explored further.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NeuroExercise: The Effect of a 12-Month Exercise Intervention on Cognition in Mild Cognitive Impairment-A Multicenter Randomized Controlled Trial. Stuckenschneider, T., Sanders, ML., Devenney, KE., et al.[2021]

Head-out aquatic exercise (AE) is effective for improving strength, flexibility, functional movements, bone density, and quality of life in healthy postmenopausal women aged 50-70, based on a review of 15 studies.

While some anthropometric and biochemical outcomes were inconclusive, the overall benefits of AE suggest it is a valuable rehabilitation method for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Head-Out Aquatic Exercise for Generally Healthy Postmenopausal Women: A Systematic Review. Binkley, HM., Rudd, LE.[2019]

Water-based exercise can be a beneficial alternative for individuals with chronic diseases or disabilities who may struggle with traditional land-based therapy, enhancing their ability to participate in physical activity.

Combining water and land exercise modalities, as exemplified by the Burdenko Method, can lead to improved therapeutic outcomes and greater overall benefits for clients, supported by over 40 years of research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The benefits of combining water and land-based therapy. Carayannopoulos, AG., Han, A., Burdenko, IN.[2020]

A systematic review of 62 studies found that water-based training (WT) significantly improves strength, balance, and cardiorespiratory fitness in healthy adults when performed for at least 12 weeks, 2-3 times a week.

For adults with chronic diseases, WT led to notable health benefits, including improved quality of life and physical fitness in conditions like fibromyalgia, diabetes, and Parkinson's disease, particularly after 8-16 weeks of training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of aquatic exercise in adults with and without chronic disease-A systematic review with meta-analysis. Faíl, LB., Marinho, DA., Marques, EA., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/9552003

Water-based Activities to Enhance Recall in Veterans ... 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 ...

2. reporter.nih.gov reporter.nih.gov/project-details/9952843

RePORT RePORTER - National Institutes of Health (NIH) | The proposed four-year randomized controlled trial will compare water-based exercise + cognitive training (WATER+CT) to a Usual Care Control Condition (UC). The ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04296565/water-based-activity-to-enhance-recall-in-veterans

Water-based Activity to Enhance Recall in Veterans This four-year study will evaluate the efficacy of an exercise training augmentation for cognitive training intervention to improve memory ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04296565?term=WATER&rank=9

Water-based Activity to Enhance Recall in Veterans Types of outcome measures include primary outcome measure and secondary outcome measure. ... A type of intervention model describing a clinical trial in which two ...

5. withpower.com withpower.com/trial/phase-4-cognitive-dysfunction-9-2021-e71b4

Water-Based Exercise + Cognitive Training for Mild ... A brief, six-day water-based exercise program significantly improved cardiovascular fitness and cognitive functions, including executive function, attention, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04296565

Water-based Activity to Enhance Recall in Veterans ... This four-year study will evaluate the efficacy of an exercise training augmentation for cognitive training intervention to improve memory performance in ...

7. trial.medpath.com trial.medpath.com/clinical-trial/00d8eb3f1e51f5f3/nct02614092-water-based-activities-enhance-recall-veterans

Water-based Activity to Enhance Recall in Veterans - MedPath This two-year study will evaluate the feasibility of an exercise training augmentation for cognitive training intervention to improve memory performance in ...