Water-based Activity to Enhance Recovery in Long COVID-19
ConditionLong COVID
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorVA Office of Research and Development
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
WATER+CT
BehavioralThis 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.
Usual Care
BehavioralThis condition involves receipt of educational materials about brain health and healthy lifestyles as well as regular contact with study staff.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: WATER+CTExperimental treatment 1 intervention
Group B: Usual CareOther 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of Intervention Measure
The FIM is a brief measure of the feasibility of an intervention.
Time frame
At the end of study completion, an average of 8 monthsSecondary outcomes
1
Acceptability of Intervention Measure
The AIM is a brief measure that assesses the acceptability of an intervention.
Time frame
At the end of study completion, an average of 8 months2
Change in Fatigue Severity Scale
The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue on a person. The FSS is a short questionnaire that requires a person to rate his/her level of fatigue using a scale of 1 (completely disagree) to 7 (completely agree). Scores range from 9 to 63 with higher scores indicating greater fatigue severity.
Time frame
Through study completion, an average of 8 months3
Change in Mental Fatigue Scale
The Mental Fatigue Scale (MFS) is self-report scale that includes 15 questions which assess mental fatigue. Items are rated on a scale that ranges from 0 (normal function) to 3 (serious problems). Higher scores indicate greater symptom severity.
Time frame
Through study completion, an average of 8 months4
Change in Digit Span
The Digit Span subt-test of the WAIS-IV assesses attention and working memory.
Time frame
Through study completion, an average of 8 monthsSponsors and contacts
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Source ClinicalTrials.gov