RecruitingNot ApplicableNCT06142253

Water-based Activity to Enhance Recovery in Long COVID-19

Water-based Activity to Enhance Recovery in Long COVID


Sponsor

VA Office of Research and Development

Enrollment

50 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

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 phase and 2) a cognitive training phase. The exercise phase will be an aquatic based exercise program. A combination exercise + memory training programs designed for persons with 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 adults, it is important to adapt these programs for persons with neurological symptoms of long-COVID.


Eligibility

Min Age: 18 YearsMax Age: 89 Years

Inclusion Criteria6

  • 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 Criteria6

  • 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

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Interventions

BEHAVIORALWATER+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.

BEHAVIORALUsual Care

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


Locations(1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

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NCT06142253


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