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

Study Objective The primary goal of this study is 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. Specific Objectives * Determine the prevalence of Long Covid-19 among participants from previous Covid-19 institutional registries, describing the primary clinical manifestations based on symptom recurrence and severity. * Administer a functional and cognitive rehabilitation strategy in patients with NCDs and Long Covid-19, and compare it with evidence-based informational messages Evaluate the impact of both interventions on key clinical outcomes, including: * Six-minute walk test performance (functional capacity) * Montreal Cognitive Assessment (MoCA) score (cognitive function) * EQ-5D-5L (quality of life assessment) * Incidence of events indicating worsening of underlying conditions Methodology The study has been conducted in two phases. The second phase is the one being registered on this platform: 1. Phase 1: Identification and Diagnosis of Long Covid-19 * Study Design: Identification of eligible patients through institutional registries at Fundación Cardioinfantil - Instituto de Cardiología (FCI-IC) and Hospital Militar Central (HOMIL). * Eligible Population: Adults (≥18 years) with a history of hypertension or type 2 diabetes mellitus who had a suspected acute SARS-CoV-2 infection between March 2020 and December 2021. * Sample Size and Recruitment: Approximately 2,240 individuals were contacted, with an expected 30% prevalence of long COVID, yielding at least 672 eligible participants for the clinical trial. Screening Procedures: * Telephone contact using a pre-established script adapted from one of the registries. * Administration of a structured questionnaire on persistent symptoms, functional limitations, and prior health conditions. Criteria for Long Covid-19 diagnosis: * Presence of at least two persistent, intermittent, or recurrent symptoms for at least four weeks. * At least one symptom significantly impacting daily activities. * Symptoms unexplained by pre-existing health conditions. Data Management: Information has been recorded in the REDCap platform, ensuring secure data collection and monitoring. 2. Phase 2: Randomized Clinical Trial * Study Design: A parallel-group, randomized controlled trial (RCT) with active control. * Eligible Participants: Those diagnosed with Long Covid-19 in Phase 1. Randomization (1:1): * Experimental Group: Functional and cognitive rehabilitation strategy. * Control Group: Informational support with evidence-based messages. Inclusion Criteria: * Confirmed Covid-19 diagnosis. * History of hypertension or diabetes before the SARS-CoV-2 infection. * Persistent symptoms affecting daily life. * Ability to participate in in-person rehabilitation or receive informational support. Exclusion Criteria: * Age \>80 years. * Advanced chronic conditions (e.g., severe heart failure, advanced kidney disease). * Hospitalizations in the year prior to study enrollment. * Cognitive or physical impairments preventing participation. * Interventions Functional and Cognitive Rehabilitation: Duration: 8 weeks, with one session per week at the study site. 1. Functional Rehabilitation (Supervised by trained health professionals) * Warm-up (8 min) * Aerobic exercise (20 min on treadmill/elliptical) * Muscle toning (8 min) * Cool-down (8 min) 2. Cognitive Rehabilitation (Guided by occupational therapy professionals) - 30-minute sessions focusing on memory, attention, and executive functions. Informational Support with evidence-based messages (Active Control): Weekly delivery of evidence-based health information via email, SMS, or WhatsApp. Topics include COVID-19 prevention, treatment, and prognosis. Three informational messages per week for 8 weeks. Outcome Measures 1. Primary Outcomes: * Six-minute walk test. * MoCA cognitive assessment. * EQ-5D-5L quality of life questionnaire. * Incidence of clinical events related to NCD deterioration. 2. Secondary Outcomes: * Fatigue severity (Fatigue Severity Scale). * Anxiety and depression (Hospital Anxiety and Depression Scale). * Disability assessment (WHO Disability Assessment Schedule 2.0). * Dyspnea severity (MRC Dyspnea Scale). Additionally, complementary measurements will be taken at the initial visit, post-intervention, and six months after completion to assess: * WHO Disability Assessment Questionnaire. * Hospital Anxiety and Depression Scale. * Fatigue Severity Scale. * MRC Dyspnea Scale. * Study Timeline and Follow-up Baseline assessment (before intervention). * Post-intervention evaluation (within 4 weeks of completion). * Six-month follow-up assessment. * Evaluations conducted by trained, blinded assessors to ensure objectivity. Ethical Considerations * Confidentiality: Participant data will be managed per ethical guidelines and stored securely. * Voluntary Participation: Participants may withdraw without affecting their standard medical care. * Safety Measures: Rehabilitation sessions will be supervised to mitigate risks such as fatigue or dizziness. * Insurance Coverage: A study-specific insurance policy will provide coverage for any adverse events related to the interventions. This study will contribute to understanding Long Covid-19 management in patients with chronic conditions, providing evidence for the development of effective rehabilitation strategies to improve patient outcomes.