Long COVIDNCT06142253
Water-based Activity to Enhance Recovery in Long COVID-19
A study testing WATER+CT in people with Long COVID, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Long COVID
- What is being tested?
- WATER+CT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
Jennifer K Fairchild, PhD, (650) 439-5000 ext. 63432, JenniferKaci.Fairchild@va.gov
Jennifer Kaci Fairchild, PhD
About this study
Official title: Water-based Activity to Enhance Recovery in Long COVID
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.
Read the 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? The investigators address the need to enhance recovery in this vulnerable population through an innovative multi-component training program that has successfully been used in other cognitively impaired populations. The aims of the proposed research include: 1) demonstrate feasibility as shown by good recruitment and retention rates and stakeholder ratings; 2) evaluate appropriateness of suggested inclusion and exclusion criteria; 3) evaluate acceptability of water-based physical exercise + cognitive training interventions; 4) assess ability of selected outcome measurement techniques to determine the efficacy of water-based physical exercise + cognitive training; and 5) examine outcome "moderator" and "mediator" measurement techniques.
These aims will be tested in a single-blind randomized controlled pilot trial that will establish the feasibility of WATER+CT. This trial will include 50 Veterans, age 18 - 89, experiencing neurological manifestations of long-COVID, with half randomized to WATER+CT and half to usual care. WATER+CT consists of two phases:
- an exercise training phase and 2) a cognitive training phase. The exercise training (i.e., WATER) consists of a six-month long individualized exercise program of water-based exercises. During this phase, Veterans will come to thrice-weekly group sessions at Aquatic Therapy Center at VA Palo Alto Health Care System (VAPAHCS). After completion of the exercise program, Veterans will begin classroom-based cognitive training at VAPAHCS for up to two months. The CT is based on an efficacious training program that is structured around two components, pre-training, and mnemonic training, both of which have been used successfully in persons with cognitive impairment. Veterans randomized to the UC control condition will receive educational materials about brain health in addition to their usual care, which is the care they would typically receive in the VA. Assessments of adherence will be administered throughout treatment and measures of feasibility will be completed post-treatment.
Participants will complete a variety of neuropsychological measures taping into areas of cognition such as attention, executive functioning, and memory. Participants will also undergo physical fitness assessments including a 6-minute walk test and an exercise treadmill test. To study possible predictors of response to treatment, the investigators will also collect physiological (VO2 max), biological (inflammatory markers and BDNF plasma levels), and genetic data (APOE and BDNF genotypes) from these participants. The investigators hope to provide initial evidence of the feasibility of a water-based exercise training + cognitive training program and provide foundational support for a future program development targeting enhanced recovery in Veterans with neurological manifestations of long-COVID.
- Conditions
- Long COVID
- Being tested
- WATER+CT, Usual Care
- Keywords
- Post-Acute COVID-19 Syndrome, Cognitive Training, Exercise, Veterans, Mental Fatigue
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Motor Activity, Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WATER+CTBehavioural
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.
Usual CareBehavioural
This condition involves receipt of educational materials about brain health and healthy lifestyles as well as regular contact with study staff.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: WATER+CT |
| Usual Care | Other | This arm consists of psychoeducation regarding brain health and healthy lifestyles. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Measure
The FIM is a brief measure of the feasibility of an intervention.
Measured: At the end of study completion, an average of 8 months
Secondary outcomes (13)
Acceptability of Intervention Measure
The AIM is a brief measure that assesses the acceptability of an intervention.
Measured: At the end of study completion, an average of 8 months
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.
Measured: Through study completion, an average of 8 months
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.
Measured: Through study completion, an average of 8 months
Change in Digit Span
The Digit Span subt-test of the WAIS-IV assesses attention and working memory.
Measured: Through study completion, an average of 8 months
Change in Digit Symbol Substitution Test
The Digit Symbol Substitution Test from the WAIS-III assesses attention, processing speed and executive function.
Measured: Through study completion, an average of 8 months
Change in Stroop Color Word Test
The Stroop Color Word test assesses selection attention, cognitive inhibition, and processing speed.
Measured: Through study completion, an average of 8 months
Change in Rey Auditory Verbal Learning Test
The Rey Auditory Verbal Learning Test; (RAVLT) assesses learning and memory.
Measured: Through study completion, an average of 8 months
Change in NIH Toolbox Cognitive Battery
The NIH Toolbox is a computerized battery of test that assesses neuropsychological function.
Measured: Through study completion, an average of 8 months
Change in Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) is a 14-time self-rating scale to assess psychological distress in non-psychiatric patients. Items are rated on a 4-point Likert scale (range 0-3). The total score ranges from 0 to 42 with higher indicating greater severity.
Measured: Through study completion, an average of 8 months
Change in World Health Organization Disability assessment scale 2.0
The World Health Organization Disability assessment scale 2.0 (WHODAS 2.0) assesses multiple domains of function including: cognition, mobility, self-care, getting along, life activities (household and work) and participation.
Measured: Through study completion, an average of 8 months
Change in Canadian Occupation Performance Measure
The Canadian Occupation Performance Measure (COPM) assesses an individual's perceived occupational performance in the areas of self-care, productivity, and leisure.
Measured: Through study completion, an average of 8 months
Change in Blood labs
Standard blood labs include C-Reactive Protein, Interleukin-6, metabolic panel, and lipid panels
Measured: Through study completion, an average of 8 months
Genetic Testing
Genetic testing includes assessment of APOE and BDNF genotypes.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be randomly assigned to one of two groups: 1) Usual Care or 2) WATER+CT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jennifer Kaci Fairchild, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142253
- Sponsor's protocol ID
- F4647-P
- Status last verified
- Jun 2026
- First submitted
- 17 Nov 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water-based Activity to Enhance Recovery in Long COVID
- ClinicalTrials.gov ID
- NCT06142253
- Acronym / sponsor ID
- F4647-P
- Conditions
- Long COVID
- Keywords
- Post-Acute COVID-19 Syndrome, Cognitive Training, Exercise, Veterans, Mental Fatigue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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? The investigators address the need to enhance recovery in this vulnerable population through an innovative multi-component training program that has successfully been used in other cognitively impaired populations. The aims of the proposed research include: 1) demonstrate feasibility as shown by good recruitment and retention rates and stakeholder ratings; 2) evaluate appropriateness of suggested inclusion and exclusion criteria; 3) evaluate acceptability of water-based physical exercise + cognitive training interventions; 4) assess ability of selected outcome measurement techniques to determine the efficacy of water-based physical exercise + cognitive training; and 5) examine outcome "moderator" and "mediator" measurement techniques.
These aims will be tested in a single-blind randomized controlled pilot trial that will establish the feasibility of WATER+CT. This trial will include 50 Veterans, age 18 - 89, experiencing neurological manifestations of long-COVID, with half randomized to WATER+CT and half to usual care. WATER+CT consists of two phases:
- an exercise training phase and 2) a cognitive training phase. The exercise training (i.e., WATER) consists of a six-month long individualized exercise program of water-based exercises. During this phase, Veterans will come to thrice-weekly group sessions at Aquatic Therapy Center at VA Palo Alto Health Care System (VAPAHCS). After completion of the exercise program, Veterans will begin classroom-based cognitive training at VAPAHCS for up to two months. The CT is based on an efficacious training program that is structured around two components, pre-training, and mnemonic training, both of which have been used successfully in persons with cognitive impairment. Veterans randomized to the UC control condition will receive educational materials about brain health in addition to their usual care, which is the care they would typically receive in the VA. Assessments of adherence will be administered throughout treatment and measures of feasibility will be completed post-treatment.
Participants will complete a variety of neuropsychological measures taping into areas of cognition such as attention, executive functioning, and memory. Participants will also undergo physical fitness assessments including a 6-minute walk test and an exercise treadmill test. To study possible predictors of response to treatment, the investigators will also collect physiological (VO2 max), biological (inflammatory markers and BDNF plasma levels), and genetic data (APOE and BDNF genotypes) from these participants. The investigators hope to provide initial evidence of the feasibility of a water-based exercise training + cognitive training program and provide foundational support for a future program development targeting enhanced recovery in Veterans with neurological manifestations of long-COVID.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible participants will be randomly assigned to one of two groups: 1) Usual Care or 2) WATER+CT
| Arm | Type | Receives |
|---|---|---|
| WATER+CT | Experimental | Behavioral: WATER+CTThis is 8-month long two phase intervention consisting of: 1) 6 months of aquatic exercise followed by 2) 2 months of cognitive training. |
| Usual Care | Other | Behavioral: Usual CareThis arm consists of psychoeducation regarding brain health and healthy lifestyles. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WATER+CTThis 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. | Behavioural | WATER+CT |
| Usual CareThis condition involves receipt of educational materials about brain health and healthy lifestyles as well as regular contact with study staff. | Behavioural | Usual Care |
Primary outcome
Feasibility of Intervention Measure
Time frame: At the end of study completion, an average of 8 months
The FIM is a brief measure of the feasibility of an intervention.
13 secondary outcomes
Acceptability of Intervention Measure
Time frame: At the end of study completion, an average of 8 months
Change in Fatigue Severity Scale
Time frame: Through study completion, an average of 8 months
Change in Mental Fatigue Scale
Time frame: Through study completion, an average of 8 months
Change in Digit Span
Time frame: Through study completion, an average of 8 months
Change in Digit Symbol Substitution Test
Time frame: Through study completion, an average of 8 months
Change in Stroop Color Word Test
Time frame: Through study completion, an average of 8 months
Change in Rey Auditory Verbal Learning Test
Time frame: Through study completion, an average of 8 months
Change in NIH Toolbox Cognitive Battery
Time frame: Through study completion, an average of 8 months
Change in Hospital Anxiety and Depression Scale
Time frame: Through study completion, an average of 8 months
Change in World Health Organization Disability assessment scale 2.0
Time frame: Through study completion, an average of 8 months
Change in Canadian Occupation Performance Measure
Time frame: Through study completion, an average of 8 months
Change in Blood labs
Time frame: Through study completion, an average of 8 months
Genetic Testing
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Long COVID
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Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Kaci Fairchild, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WATER+CT in people with Long COVID, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer K Fairchild, PhD ((650) 439-5000 ext. 63432, JenniferKaci.Fairchild@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention Measure (time frame: At the end of study completion, an average of 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.