Status:
RECRUITING
Water-based Activity to Enhance Recovery in Long COVID-19
Lead Sponsor:
VA Office of Research and Development
Conditions:
Long COVID
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
This two-year study will evaluate the feasibility and safety of an exercise + cognitive training program to improve neurological symptoms of long-COVID. This is a two-phased trial: 1) an exercise phas...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06142253
Start Date
December 1 2024
End Date
December 31 2026
Last Update
January 28 2025
Active Locations (1)
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1
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1207