RECRUITING

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

Conditions

Long COVID Post-Acute COVID-19 Syndrome Cognitive Training Exercise Veterans Mental Fatigue

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Water-based Activity to Enhance Recovery in Long COVID

Quick Facts

Study Start:2024-12-01

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06142253

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Jennifer K Fairchild, PhD

CONTACT

(650) 439-5000

JenniferKaci.Fairchild@va.gov

Principal Investigator

Jennifer Kaci Fairchild, PhD

PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System, Palo Alto, CA

Study Locations (Sites)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Jennifer Kaci Fairchild, PhD, PRINCIPAL_INVESTIGATOR, VA Palo Alto Health Care System, Palo Alto, CA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-01

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-12-01

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

Post-Acute COVID-19 Syndrome
Cognitive Training
Exercise
Veterans
Mental Fatigue

Additional Relevant MeSH Terms

Long COVID