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

NCT06142253 | Recruiting

• 1 other identifier: F4647-P
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Long COVID

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Feasibility of Intervention Measure

  The FIM is a brief measure of the feasibility of an intervention.

  At the end of study completion, an average of 8 months

Secondary Outcomes (13)

• Acceptability of Intervention Measure

  At the end of study completion, an average of 8 months

• Change in Fatigue Severity Scale

  Through study completion, an average of 8 months

• Change in Mental Fatigue Scale

  Through study completion, an average of 8 months

• Change in Digit Span

  Through study completion, an average of 8 months

• Change in Digit Symbol Substitution Test

  Through study completion, an average of 8 months

Study Arms (2)

WATER+CT

EXPERIMENTAL

This is 8-month long two phase intervention consisting of: 1) 6 months of aquatic exercise followed by 2) 2 months of cognitive training.

Behavioral: WATER+CT

Usual Care

OTHER

This arm consists of psychoeducation regarding brain health and healthy lifestyles.

Behavioral: Usual Care

Interventions

WATER+CT BEHAVIORAL

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.

WATER+CT

Usual Care BEHAVIORAL

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

Usual Care

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Motor Activity; Mental Fatigue

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Fatigue; Signs and Symptoms; Behavioral Symptoms

Study Officials

• Jennifer Kaci Fairchild, PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer K Fairchild, PhD

CONTACT

(650) 439-5000; JenniferKaci.Fairchild@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will be blinded to study allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Eligible participants will be randomly assigned to one of two groups: 1) Usual Care or 2) WATER+CT

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 21, 2023
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)