Digital Multimodal Rehabilitation for People With Post-acute COVID-19 Syndrome.

NCT ID: NCT05846126

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-12-31

Brief Summary

Although most infected people survive the infection, many have persistent sequelae or symptoms, which cause disability or decreased quality of life. The World Health Organization has called on countries to prioritize the rehabilitation of the consequences of COVID-19 in both the medium and long term, as this chronicity is expected to impact the health public and the economy in the coming years.

RehabCOVID (also referred to as RehabNautilus) is born from the need to provide solutions to persistent cognitive impairment symptoms of people who have suffered from COVID-19. Thus, we will offer people with long COVID that accomplish inclusion/exclusion criteria to participate in a randomized clinical trial to evaluate the effectiveness of cognitive stimulation therapy combined with physical exercise and mindfulness. The current project is a single-blind randomized control 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.

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.

Conditions

Post-COVID Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Telematic group

This program combines cognitive training, physical exercise, and mindfulness tasks delivered remotely to participants. The cognitive training includes 24 interactive sessions over 12 weeks aimed at training attention, memory, and executive function. The physical exercise program is personalized and includes balance work, stretching, and muscle strengthening exercises, with two sessions per week for 12 weeks. The mindfulness component adapts the Mindfulness-Based Stress Reduction program, including body scanning, seated meditation, and gentle Hatha yoga, with one supervised session per week via video call over 12 weeks. The program is designed for autonomous use by participants.

Group Type: EXPERIMENTAL

RehabCovid_Telematic

Intervention Type: BEHAVIORAL

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

Immersive Virtual Reality group

The sessions will consist of carrying out a face-to-face multimodal stimulation program with the application of MK360 immersive technology for the cognitive, emotional, behavioral, physical, functional - social areas. The multimodal intervention includes 24 interactive sessions two sessions per week, over 12 weeks. They will follow the following scheme:

1. Welcome and awareness of the here and now.

2. Physical activation.

3. Cognitive stimulation.

4. Relaxation techniques and Mindfulness.

5. Feedback and end of session.

During the intervention period, patients will be provided with a downloadable App with a username and password, so they can access it. From the App, they will view the tests to answer according to tempos and therapeutic direction.

Group Type: EXPERIMENTAL

RehabCovid_ImmersiveVR

Intervention Type: BEHAVIORAL

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

Active control program

In paper or pdf format, patients in the active control group will receive guidelines for physical and cognitive stimulation to do autonomously at home. Patients in the active control group will receive guidelines for cognitive and physical stimulation and meditation exercises in paper or pdf format, to be done independently at home. They will be encouraged to do physical exercises, meditation, and cognitive activities two times a week.

Group Type: ACTIVE_COMPARATOR

Control_Condition

Intervention Type: BEHAVIORAL

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

Interventions

RehabCovid_Telematic

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Control_Condition

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Barcelona

OTHER

Sponsor Role: collaborator

Universitat de Girona

OTHER

Sponsor Role: collaborator

Unitat Assistencial i Preventiva de l'Esport- Centre d'Alt rendiment

UNKNOWN

Sponsor Role: collaborator

Universitat Politècnica de Catalunya

OTHER

Sponsor Role: collaborator

Corporación Fisiogestión

UNKNOWN

Sponsor Role: collaborator

Consorci Sanitari de Terrassa

OTHER

Sponsor Role: lead

Responsible Party

Maite Garolera

Principal Investigator of the Brain, Cognition, and Behavior Research Group (C3-CST).

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Consorci Sanitari de Terrassa

Terrassa, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Maite Garolera

Role: CONTACT

mgarolera@cst.cat

+34937310007

Facility Contacts

Maite Garolera

Role: primary

mgarolera@cst.cat

+34937310007

Other Identifiers

TED2021-130409B-C51

Identifier Type: -

Identifier Source: org_study_id