Recruiting

Evaluating the Impact of a Functional and Cognitive Strategy in Patients With Long Covid-19

ClinicalTrials.gov IDNCT06871293

PhaseNA

Enrollment374

SponsorFundación Cardioinfantil Instituto de Cardiología

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Long COVID-19 Syndrome, COVID 19, Noncommunicable Disease, Hypertension, Diabetes Mellitus, Long COVID

About this study

This study aims to evaluate the impact of a functional and cognitive rehabilitation strategy compared to evidence-based informational messages, on functional capacity, cognitive abilities, quality of life, and disease progression in adults with chronic non-communicable diseases (NCDs) and Long Covid-19. Researchers will compare a structured rehabilitation program to informational support through evidence-based messages to determine if rehabilitation leads to better functional and cognitive outcomes in patients with Long Covid-19. Participants will be randomly assigned to one of two groups: 1. Functional and cognitive rehabilitation: Attending weekly in-person sessions for 8 weeks, including supervised physical and cognitive exercises. 2. Informational support: Receiving weekly evidence-based educational messages for 8 weeks. Participants will undergo assessments at baseline, post-intervention, and six months later, including a six-minute walk test, handgrip strength measurement, and questionnaires on disability, anxiety, depression, fatigue, dyspnea, cognitive function, and quality of life.

Interventions

Other: Functional and cognitive rehabilitation strategy — The functional and cognitive rehabilitation strategy is a structured, supervised program, designed to improve physical and cognitive function in patients with Long Covid-19 and chronic diseases. Participants will attend weekly in-person sessions for 8 weeks at study sites. Each session includes: * Functional Rehabilitation (60 min): Warm-up, aerobic exercise (elliptical/treadmill), muscle strengthening, and cool-down, all supervised by trained healthcare professionals who monitor effort levels and heart rate. * Cognitive Rehabilitation (30 min): Memory, attention, and executive function exercises, guided by occupational therapists or speech therapists.
Other: Evidence-Based Informational Support — The evidence-based informational support intervention provides structured, research-based health information to patients with Long Covid-19 and chronic diseases. Participants receive weekly digital messages for 8 weeks via email or text, covering key topics such as Covid-19 prevention, treatment, follow-up, and prognosis. Content is derived from high-quality scientific studies and clinical guidelines. A total of 24 informational pieces are delivered, ensuring comprehensive coverage of essential health recommendations. This intervention is remote, accessible, and designed to enhance patient knowledge and self-management, distinguishing it from traditional in-person education programs.

Primary outcomes

Composite Change in Functional Capacity, Cognitive Function, Health-Related Quality of Life, and Strength (Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.)

Eligibility information

Inclusion Criteria: * Covid-19 confirmed. * History of arterial hypertension or diabetes mellitus before entering the institutional registries of the FCI-IC or HOMIL, institutional registries of the FCI-IC or HOMIL or before having the diagnosis of SARSCoV-2 infection. * Persistence of two or more concurrent symptoms, related to Covid-19 prologue, for at least 4 weeks (persistent, intermittent, or intermittent). * At least one of these symptoms must have an impact on activities of daily living. They can be physical (fatigue, dyspnea, myalgias, arthralgias) or neuropsychiatric (cognitive, sleep and emotional alterations). * Symptoms unexplained by underlying disease or other condition concomitant with SARS-CoV-2 infection. SARS-CoV-2 infection (determined by prior medical history review and participant interview). participant interview). \- Ability to read and attend functional and cognitive rehabilitation sessions or to receive the with evidence-based informational messages. Exclusion Criteria: * Age \>80 years. * Severely advanced baseline comorbidities prior to SARS-CoV-2 infection. * Presence of chronic respiratory disease (partial or permanent supplemental oxygen use), cardiac failure (LVEF\<40%) or advanced renal disease (GFR\<30%). heart failure (LVEF\<40%) or advanced renal disease (GFR\<30). * Two hospitalizations in the year prior to admission to the institutional registries of the FCI-IC and the HOMIL for the patient's underlying disease. * Dependence on a caregiver. * Orthopedic or cardiopulmonary problems that contraindicate the performance of aerobic exercise. * Neuropsychiatric or cognitive limitations that limit understanding or following commands and performing attention exercises.

Study locations

Fundación Cardioinfantil-Instituto de cardiología, Bogotá, Bogotá DC 110131 Colombia

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-28.