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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Consorci Sanitari de Terrassa
RECRUITING
Terrassa
Contact Information
Primary
Maite Garolera
mgarolera@cst.cat
+34937310007
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 158
Treatments
Experimental: 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.
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Corporación Fisiogestión, University of Barcelona, Universitat de Girona, Unitat Assistencial i Preventiva de l'Esport- Centre d'Alt rendiment, Universitat Politècnica de Catalunya
Leads: Consorci Sanitari de Terrassa

This content was sourced from clinicaltrials.gov