This two-year study will evaluate the feasibility and safety of an exercise + cognitivetraining program to improve neurological symptoms of long-COVID. This is a two-phasedtrial: 1) an exercise phase and 2) a cognitive training phase. The exercise phase will bean aquatic based exercise program. A combination exercise + memory training programsdesigned for persons with cognitive impairment have significantly improved memory morethan other single intervention groups (exercise only, cognitive training only) and giventhe success of combination training programs with healthy adults, it is important toadapt these programs for persons with neurological symptoms of long-COVID.
The primary research question of the proposed study is this: Is a water-based exercise +
cognitive training (WATER+CT) intervention for Veterans with neurological manifestations
of long-COVID feasible? The investigators address the need to enhance recovery in this
vulnerable population through an innovative multi-component training program that has
successfully been used in other cognitively impaired populations. The aims of the
proposed research include: 1) demonstrate feasibility as shown by good recruitment and
retention rates and stakeholder ratings; 2) evaluate appropriateness of suggested
inclusion and exclusion criteria; 3) evaluate acceptability of water-based physical
exercise + cognitive training interventions; 4) assess ability of selected outcome
measurement techniques to determine the efficacy of water-based physical exercise +
cognitive training; and 5) examine outcome "moderator" and "mediator" measurement
techniques.
These aims will be tested in a single-blind randomized controlled pilot trial that will
establish the feasibility of WATER+CT. This trial will include 50 Veterans, age 18 - 89,
experiencing neurological manifestations of long-COVID, with half randomized to WATER+CT
and half to usual care. WATER+CT consists of two phases:
1) an exercise training phase and 2) a cognitive training phase. The exercise training
(i.e., WATER) consists of a six-month long individualized exercise program of
water-based exercises. During this phase, Veterans will come to thrice-weekly group
sessions at Aquatic Therapy Center at VA Palo Alto Health Care System (VAPAHCS).
After completion of the exercise program, Veterans will begin classroom-based
cognitive training at VAPAHCS for up to two months. The CT is based on an
efficacious training program that is structured around two components, pre-training,
and mnemonic training, both of which have been used successfully in persons with
cognitive impairment. Veterans randomized to the UC control condition will receive
educational materials about brain health in addition to their usual care, which is
the care they would typically receive in the VA. 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. Participants will also
undergo physical fitness assessments including a 6-minute walk test and an exercise
treadmill test. To study possible predictors of response to treatment, the investigators
will also collect physiological (VO2 max), biological (inflammatory markers and 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 water-based
exercise training + cognitive training program and provide foundational support for a
future program development targeting enhanced recovery in Veterans with neurological
manifestations of long-COVID.
Behavioral: WATER+CT
This is an 8-month long two phase intervention. The first phase consists of 6 months of
thrice weekly pool-based exercise occurring at VA Palo Alto. After completion of the 6
month long pool based exercise, participants transition to ten sessions of cognitive
training that will occur over 2 months at the VA Palo Alto.
Behavioral: Usual Care
This condition involves receipt of educational materials about brain health and healthy
lifestyles as well as regular contact with study staff.
Inclusion Criteria:
- Veterans, age 18 to 89, of any racial or ethnic group
- Previous COVID-19 infection at least 6 months after diagnosis documented in clinical
record
- Persistent neurological symptoms (e.g., "brain fog", cognitive impairment) occurring
within 3 months of onset of COVID-19 infection and lasting at least 8 weeks in
duration
- Visual and auditory acuity to allow neuropsychological testing
- Willingness to participate in clinical trial for 8 months
- Approval by Primary Care Provider to participate in water-based physical exercise
Exclusion Criteria:
Psychiatric Exclusions
- Current, uncontrolled severe psychotic disorder determined by the Mini International
Neuropsychiatric Interview (MINI) Medical Exclusions
- History of neurological (e.g., multiple sclerosis, seizure disorder, stroke,)
neurodegenerative (e.g., Parkinson's disease, Alzheimer's disease) or system illness
affecting CNS function (e.g., liver failure, kidney failure, congestive heart
failure, systemic cancer) occurring before COVID-19 diagnosis
- 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 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 6 months)
- Inability to participate in an exercise stress test
- Inability to read, verbalize understanding and voluntarily sign the Informed Consent
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States
Investigator: Jennifer K Fairchild, PhD
Contact: (650) 439-5000
JenniferKaci.Fairchild@va.gov
Investigator: Jennifer Kaci Fairchild, PhD
Jennifer K Fairchild, PhD
(650) 439-5000 - 63432
JenniferKaci.Fairchild@va.gov
Jennifer Kaci Fairchild, PhD, Principal Investigator
VA Palo Alto Health Care System, Palo Alto, CA