Water-Based Exercise + Cognitive Training for Mild Cognitive Impairment

(WATER-Vet Trial)

Overseen by Jennifer Kaci Fairchild, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Bipolar, Schizophrenia, Dementia, Stroke, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This four-year study will evaluate the efficacy 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.

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 data supports the effectiveness of the treatment Water-Based Exercise + Cognitive Training for Mild Cognitive Impairment?

Research shows that combining physical exercise and cognitive training can improve memory and attention in older adults with mild cognitive impairment. Water-based exercise, in particular, offers similar benefits to land-based exercise with a lower risk of injury, making it a suitable option for older adults. ^{1 2 3 4 5}

Is water-based exercise with cognitive training safe for humans?

Water-based exercise is generally safe for humans, providing benefits like improved fitness and reduced injury risk. Studies show it helps with balance, strength, and quality of life in both healthy adults and those with chronic diseases. ^{1 4 5 6 7}

How does the WATER+CT treatment differ from other treatments for mild cognitive impairment?

The WATER+CT treatment is unique because it combines water-based exercise with cognitive training, which may be more accessible for older adults compared to traditional land-based exercises. This combination aims to maximize cognitive benefits by addressing both physical and mental aspects, potentially offering greater improvements than either approach alone. ^{3 4 5 7 8}

Research Team

Jennifer Kaci Fairchild, PhD

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Usual Care (Behavioral Intervention)
• WATER+CT (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

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]

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]

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]

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]

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 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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The effects of a brief, water-based exercise intervention on cognitive function in older adults. [2015]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

The benefits of combining water and land-based therapy. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Comparison between physical and cognitive treatment in patients with MCI and Alzheimer's disease. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Head-Out Aquatic Exercise for Generally Healthy Postmenopausal Women: A Systematic Review. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Cognitive Improvement Following Physical Exercise and Cognitive Training Intervention for Older Adults With MCI. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Water-Based Training Programs Improve Functional Capacity, Cognitive and Hemodynamic Outcomes? The ACTIVE Randomized Clinical Trial. [2023]

7. Denmark pubmed.ncbi.nlm.nih.gov

Benefits of aquatic exercise in adults with and without chronic disease-A systematic review with meta-analysis. [2022]

8. Switzerland 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. [2021]