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.
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).
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%).
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.
Parallel
Functional and cognitive rehabilitation strategy
Other interventionThe 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.
Evidence-Based Informational Support
Other interventionThe 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.
Composite Change in Functional Capacity, Cognitive Function, Health-Related Quality of Life, and Strength
The primary outcome is a composite measure evaluating the aggregated change across four key functional and cognitive scales: * Functional Capacity with six-minute walk test. * Cognitive Function with Montreal Cognitive Assessment, MoCA. The minimum score is 0 points, which would indicate very severe cognitive impairment, since the maximum total score is 30 points. Normally, a score of 26 or higher is considered within the normal range, although the range may vary depending on factors such as the patient's age and educational level. A score below 26 could suggest possible cognitive impairment, and the lower the score, the more indicative it may be of severe cognitive problems. * Health-Related Quality of Life with EuroQol 5 Dimensions 5 Levels, EQ-5D-5L. Maximum value: 1 This value corresponds to the best possible health state. Minimum value: -0.594 This value corresponds to the worst possible. * Handgrip Strength with hydraulic dynamometer.
Change in Functional Capacity
Distance covered in six minutes will be measured and compared to baseline values. Additional tests include the four-step climb power test and the 30-second sit-to-stand test, evaluating lower body strength and endurance. Greater distance indicates better functional capacity. Lower values may indicate physical dysfunction or a chronic illness.
Change in Cognitive Function
Montreal Cognitive Assessment scores will be used to assess changes in memory, visuospatial abilities, executive function, attention, language, and orientation. The minimum score is 0 points, which would indicate very severe cognitive impairment, since the maximum total score is 30 points. Normally, a score of 26 or higher is considered within the normal range, although the range may vary depending on factors such as the patient's age and educational level. A score below 26 could suggest possible cognitive impairment, and the lower the score, the more indicative it may be of severe cognitive problems.
Change in Health-Related Quality of Life
Changes in mobility, self-care, usual activities, pain/discomfort, and anxiety/depression will be evaluated using EuroQol 5 Dimensions 5 Levels. Maximum value: 1 This value corresponds to the best possible health state. Minimum value: -0.594 This value corresponds to the worst possible.
Change in Health-Related Quality of Life, Visual Analogue Scale
In addition to the score based on the 5 dimensions, the VAS scale from 0 to 100, where: 0 represents the worst imaginable health and 100 represents perfect health.
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Fundación Cardioinfantil Instituto de Cardiología
Lead sponsor
Hospital Militar Central, Colombia
Collaborator
