Supervised Computerized Active Program for People With Post-COVID Syndrome (SuperCAP Study)

NCT06315894 | Completed

• 1 other identifier: PI-22-191
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

SuperCAP study is a project aimed at designing and implementing an online program for improvement of cognitive, emotional, and functional status in post-COVID condition.

Conditions

Post-COVID Condition

Keywords

Long COVID (LC); Post-Acute COVID-19 Syndrome (PACS); Post-Acute Sequelae of COVID-19 (PASC); Post-Acute Sequelae of SARS-CoV-2 (PASS); Post-COVID Condition (PCC); Post-COVID Syndrome (PCS)

Outcome Measures

Primary Outcomes (1)

• Change in Self-reported Cognitive Functioning

  Understanding and Communicating Scale (D1) from WHODAS 2.0 questionnaire. Scores from 0 to 20. Lower scores indicate better functioning, higher scores worse functioning.

  From Baseline to Week 12

Secondary Outcomes (6)

• Change in Performance-based Cognitive Functioning

  From Baseline to Week 12

• Change in Depression Symptoms

  From Baseline to Week 12

• Change in Anxiety Symptoms

  From Baseline to Week 12

• Change in Daily Activities Functioning

  From Baseline to Week 12

• Change in Physical Activity

  From Baseline to Week 12

Study Arms (2)

Experimental

EXPERIMENTAL

People with post-COVID syndrome following the intervention

Device: SuperCAP Program

Control

NO INTERVENTION

People with post-COVID syndrome not following the intervention

Interventions

SuperCAP Program DEVICE

Distance program including tasks and exercises to improve cognitive, emotional, and functional status. The intervention will be applied via cell phone and will have a duration of 3 months (12 weeks). Tasks and exercises will be performed 5 days per week. Contents of the program will include daily exercises, daily games, daily videos, and weekly videos. They will address cognitive functions, daily habits, and lifestyle factors in general. Compliance will be monitored to control the adherence to the intervention. The program has been designed specifically for people with post-COVID syndrome.

Experimental

Eligibility Criteria

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

You may qualify if:

• Presenting Post-COVID Syndrome, defined as presenting 3 or more symptoms associated with post-COVID condition for at least 3 months.
• Age of 18-65 years old.
• Presence of self-reported cognitive complaints associated with post-COVID infection.
• Positive and favorable attitude on the use of electronic devices.
• Will to participate in a stimulation program for improvement of cognitive symptoms.
• Availability of cell phone and computer or tablet with the minimum technical features considered.

You may not qualify if:

• Inability to undergo the neuropsychological tests or complementary study assessments.
• Current participation in a trial or program for improvement of post-COVID symptoms.
• Any condition that in the opinion of the investigator would make study participation unsafe, complicate interpretation of study outcome data, interfere with achieving the study objectives, or otherwise could impair the subject's ability to complete the study.

Sponsors & Collaborators

• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia: lead
• Institut de Recerca de la SIDA IrsiCaixa: collaborator
• Germans Trias i Pujol Hospital: collaborator

Study Sites (1)

Germans Trias I Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 18, 2024
• Study Start: October 3, 2023
• Primary Completion: September 5, 2024
• Study Completion: September 5, 2024
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

ES (1)