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

NCT05846126 | Completed

• 1 other identifier: TED2021-130409B-C51
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-COVID Syndrome

Keywords

COVID-19; Immersive Virtual Reality; Cognition; Cognitive Training; Physical Exercise; Mindfulness

Outcome Measures

Primary Outcomes (13)

• Differences between groups in scores of global cognition

  Global cognition was assessed with the Montreal Cognitive Assessment (MoCA) a screening tool designed to identify mild cognitive impairment (MCI) and other cognitive deficits. The MoCA takes around 10-15 minutes to complete and consists of 30 items (range=0-30). Higher scores mean a better outcome.

  Before the intervention and 12 weeks later

• Differences between groups in scores of selective attention, inhibition, and processing speed

  Selective attention, inhibition, and processing speed are measured with the Stroop Color and Word Test. Participants are asked to name the color of a series of color patches (Stroop Color Naming), read a series of color words (Stroop Word Reading), and name the color of a series of color words where the word and color do not match (e.g., the word "red" written in blue ink), Stroop Color-Word Interference. Higher scores mean a better outcome.

  Before the intervention and 12 weeks later

• Differences between groups in scores of Visual scanning and processing speed

  Visual scanning and processing speed are measured with the Trail-Making Test-A version. Participants are asked to connect a series of numbered circles on a page in numerical order. Higher scores mean a better outcome.

  Before the intervention and 12 weeks later

• Differences between groups in scores of Executive functioning and cognitive flexibility

  Executive functioning and cognitive flexibility are measured with the Trail-Making Test-B version. Participants are asked to connect a series of circles that contain both numbers and letters in alternating numerical and alphabetical order. Higher scores mean a better outcome.

  Before the intervention and 12 weeks later

• Differences between groups in scores of auditory attention

  Auditory attention is measured with Digit Span Forward from WAIS-IV. Participants are asked to repeat numbers in the same order as read aloud by the examiner. Higher scores mean a better outcome.

  Before the intervention and 12 weeks later

• Differences between groups in scores of working memory_DSB

  Working memory is measured with Digit Span Backward from WAIS-IV. Participants are asked to repeat the numbers in the reverse order of that presented by the examiner. Higher scores mean a better outcome.

  Before the intervention and 12 weeks later

• Differences between groups in scores of Perceptual Reasoning

  Perceptual Reasoning is measured with Matrices from the WAIS-IV. Participants are presented with a pattern or design with one missing piece and are asked to select the correct piece from a set of options to complete the pattern. Higher scores on the Perceptual Reasoning Index mean a better outcome.

  Before the intervention and 12 weeks later

• Differences between groups in scores of sustained attention and impulsivity

  Conners Continuous Performance Test - 2nd edition (CPT-II) is task-oriented computerised assessment of attention-related problems. Participants are presented with a repetitive array of visual stimuli on a computer screen for 14 min. Participants are instructed to press the space bar every time a letter other than "X" appears and to not press the space bar when "X" appears. The rate of stimulus presentation varies according to 1, 2, and 4 s intervals throughout the task. Measures: Correct Detection (Higher rates indicate better outcome), Reaction times (Lower scores indicate better outcome), Omission errors (Lower rates indicate better outcome), and Commission errors (Lower rates indicate better outcome).

  Before the intervention and 12 weeks later

• Differences between groups in scores of processing speed

  The Digit Symbol Coding subtest from the WAIS-III is a neuropsychological assessment instrument for the detection of brain dysfunction in children and adults. It consists of replacing symbols that lack verbal meaning with numbers based on a key. Higher scores indicate better outcomes.

  Before the intervention and 12 weeks later

• Differences between groups in scores of verbal memory and learning

  Verbal memory and learning are measured with the Rey Auditory Verbal Learning Test (RAVLT). It is a word-learning test where five presentations of a 15-word list are given, each followed by an attempted recall. This is followed by a second 15-word interference list (list B), followed by a recall of list A. Delayed recall and recognition are also tested. Higher scores mean a better outcome.

  Before the intervention and 12 weeks later

• Differences between groups in scores of phonetic fluency

  Phonetic fluency is measured with the FAS test. It consists of saying words that start with a certain letter, as many words as possible must be mentioned during a specific time of 1 minute. The standard administration of the test provides three letters, the most used are the letters F, A, and S. Higher scores indicate better performance.

  Before the intervention and 12 weeks later

• Differences between groups in scores of semantic verbal fluency

  Semantic verbal fluency is measured with the ANIMAL test. It consists of generating the name of as many species of animals as possible within 1min. Higher scores indicate better performance.

  Before the intervention and 12 weeks later

• Differences between groups in scores of memory and everyday forgetfulness

  Memory and everyday forgetfulness are measured with The Memory Failures of Everyday-MFE Questionnaire is a self-reported test that allows an assessment of memory and everyday forgetfulness. It is a unifactorial questionnaire and consists of 30 items. The total score results from the sum of the scores in each item, from 1 to 30. The MFE can assess the current situation of the patients and their evolution long-term or changes due to treatment. Scores \<8 represent an optimal memory function. Lower scores indicate better outcomes.

  Before the intervention and 12 weeks later

Secondary Outcomes (14)

• Differences between groups in scores of anxiety

  Before the intervention and 12 weeks later

• Differences between groups in scores of depression

  Before the intervention and 12 weeks later

• Differences between groups in scores of Mindfulness levels

  Before the intervention and 12 weeks later

• Differences between groups in scores of Fatigue

  Before the intervention and 12 weeks later

• Differences between groups in scores of psychological flexibility

  Before the intervention and 12 weeks later

Study Arms (3)

Telematic group

EXPERIMENTAL

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.

Behavioral: RehabCovid_Telematic

Immersive Virtual Reality group

EXPERIMENTAL

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.

Behavioral: RehabCovid_ImmersiveVR

Active control program

ACTIVE COMPARATOR

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.

Behavioral: Control_Condition

Interventions

RehabCovid_Telematic BEHAVIORAL

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

Telematic group

RehabCovid_ImmersiveVR BEHAVIORAL

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

Immersive Virtual Reality group

Control_Condition BEHAVIORAL

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

Active control program

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorci Sanitari de Terrassa: lead
• University of Barcelona: collaborator
• Universitat de Girona: collaborator
• Unitat Assistencial i Preventiva de l'Esport- Centre d'Alt rendiment: collaborator
• Universitat Politècnica de Catalunya: collaborator
• Corporación Fisiogestión: collaborator

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, 08227, Spain

Location

Related Publications (1)

• Ariza M, Cano N, Carnes-Vendrell A, Gelonch O, Plana Y, Porras-Garcia B, Lopez-Soley E, Moron S, Pinol-Ripoll G, Garolera M; REHAB Project Collaborative Group. Addressing persistent symptoms in post-COVID condition: Through a multimodal intervention delivered in two technology-based formats. Digit Health. 2026 Apr 23;12:20552076261428205. doi: 10.1177/20552076261428205. eCollection 2026 Jan-Dec.

  PMID: 42058732 DERIVED

MeSH Terms

Conditions

COVID-19; Motor Activity

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of the Brain, Cognition, and Behavior Research Group (C3-CST).

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 6, 2023
• Study Start: May 5, 2023
• Primary Completion: December 20, 2024
• Study Completion: December 31, 2024
• Last Updated: April 30, 2026

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)