Official Title
Digital Rehabilitation With Cognitive Training, Physical Activity and Mindfulness for People With Post-acute COVID-19 Syndrome With Cognitive Impairment. REHABCOVID Project.
Brief Summary

Although most infected people survive the infection, many have persistent sequelae orsymptoms, which cause disability or decreased quality of life. The World HealthOrganization has called on countries to prioritize the rehabilitation of the consequencesof COVID-19 in both the medium and long term, as this chronicity is expected to impactthe health public and the economy in the coming years.RehabCOVID (also referred to as RehabNautilus) is born from the need to provide solutionsto persistent cognitive impairment symptoms of people who have suffered from COVID-19.Thus, we will offer people with long COVID that accomplish inclusion/exclusion criteriato participate in a randomized clinical trial to evaluate the effectiveness of cognitivestimulation therapy combined with physical exercise and mindfulness. The current projectis a single-blind randomized control study, where we will compare two combinedinterventions with a control group that will encompass different functional, structural,and biochemical changes and interactions in the brain. We will study the effects thatthis combined intervention produces in the brain. We expect to gain more insight into thespecific neuroplasticity mechanisms of cognitive persistent COVID symptoms.

Detailed Description

The current project is a single-blind randomized clinical study, where we will compare
two combined interventions with a control group that will encompass different functional,
structural, and biochemical changes and interactions in the brain. We will study the
effects that this combined intervention produces in the brain. We expect to gain more
insight into the specific neuroplasticity mechanisms of cognitive persistent COVID
symptoms.

Specifically, we aim to:

1. Examine the effects of a combined intervention in a population of long-COVID
patients on various domains: cognition; emotion; physical health and quality of
life.

2. Study the molecular mechanisms (biomarkers of inflammation, vascular risk, growth
factors, angiogenesis, neurogenesis, and cellular metabolism markers of neural
plasticity) by which the combined interventions influence brain functions.

3. Compare the levels of neural plasticity-related miRNAs and Sirt-1 protein in the
plasma of long-COVID patients of the experimental groups versus the active control
group.

4. Examine specific plasticity effects of each of the two interventions regarding
structural magnetic resonance imaging (MRI) combined with volumetry and morphometry,
resting-state functional MRI.

5. Determine the influence that demographic characteristics, previous pathologies,
lifestyle, baseline brain state, and genetic polymorphisms can have on
neuroplasticity.

We hypothesize that we will find recovery in our three groups, although it will be
enhanced in the two experimental groups (those that combine cognitive training with
physical activity and mindfulness) compared to our control group.

1. Post-COVID patients of the experimental groups will perform better than those
patients of the active control group in cognition (episodic memory tests, executive
function, attention, and speed processing), functional capacity, mental health, and
quality of life measures at the end of the intervention.

2. Post-COVID patients of the experimental groups will show greater changes in
biomarkers than those patients of the active control group at the end of the
intervention. These changes will include higher levels of Sirt-1 and regulation of
neural plasticity-related miRNAs in plasma from patients in the experimental group.

3. We will find an association between changes in biomarkers and cognitive, functional
capacity and mental health outcomes in individuals of the experimental groups.

4. Post-COVID patients of the experimental groups will show greater improvements in
grey and white matter structural data and functional connectivity than those
patients of the active control group at the end of the intervention.

Recruiting
Post-Covid Syndrome

Behavioral: RehabCovid_Telematic

A multimodal and digitally-based cognitive training, physical exercise, and mindfulness
intervention delivered remotely.

Behavioral: RehabCovid_ImmersiveVR

A multimodal and digitally-based cognitive training, physical exercise and mindfulness
intervention delivered face to face and through 360MK Virtual Reality technology

Behavioral: Control_Condition

Traditional paper or pdf format multimodal intervention that will combine cognitive,
mediation and physical activities.

Eligibility Criteria

Inclusion Criteria:

- Over 18 years old.

- Participants with a diagnosis of COVID-19 presenting persistent neurological
symptoms at least 12 weeks after acute infection.

- They will have cognitive complaints

- Consent from a physician to engage in an exercise intervention

Exclusion Criteria:

- Established diagnosis before COVID-19 disease of psychiatric, neurological,
developmental disorder, or systemic pathologies are known to cause cognitive
deficits.

- Motor or sensory alterations that impede the rehabilitation program.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 100 Years
Countries
Spain
Locations

Consorci Sanitari de Terrassa
Terrassa, Spain

Investigator: Maite Garolera
Contact: +34937310007
mgarolera@cst.cat

Contacts

Maite Garolera
+34937310007
mgarolera@cst.cat

Not Provided

Consorci Sanitari de Terrassa
NCT Number
Keywords
Covid-19
Immersive Virtual Reality
Cognition
Cognitive Training
physical exercise
Mindfulness
MeSH Terms
COVID-19
Post-Acute COVID-19 Syndrome
Syndrome