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

NCT06871293 | Recruiting DMC

• 2 other identifiers: 2024PROEPI0164ATENEA-366-2022
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Functional and cognitive rehabilitation: Attending weekly in-person sessions for 8 weeks, including supervised physical and cognitive exercises.
2. 2.Informational support: Receiving weekly evidence-based educational messages for 8 weeks.

Conditions

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

Keywords

Covid 19; Sars CoV 2; Post-acute Covid-19 syndrome; Long Covid; Hypertension; Diabetes Mellitus; Noncommunicable disease; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.

Secondary Outcomes (7)

• Change in Functional Capacity

  Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.

• Change in Cognitive Function

  Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.

• Change in Health-Related Quality of Life

  Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.

• Change in Health-Related Quality of Life, Visual Analogue Scale

  Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.

• Change in Handgrip Strength, Hydraulic Dynamometer

  Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.

Study Arms (2)

Functional and Cognitive Rehabilitation

ACTIVE COMPARATOR

Participants assigned to the functional and cognitive rehabilitation strategy will attend one weekly session for 8 weeks at study sites. Each session includes one hour of functional rehabilitation (warm-up, aerobic exercise, muscle strengthening, and cool-down) supervised by healthcare professionals who monitor effort levels and heart rate. Additionally, participants will receive 30 minutes of cognitive rehabilitation, focusing on memory, attention, and executive functions, guided by occupational therapists or speech therapists. This intervention aims to enhance physical and cognitive function in patients with chronic diseases and Long Covid-19.

Other: Evidence-Based Informational Support

Evidence-Based Informational Support

ACTIVE COMPARATOR

Participants assigned to the evidence-based informational support arm will receive weekly educational messages for 8 weeks via email or text messages. These messages are derived from a thorough review of high-quality scientific studies and cover key topics related to Covid-19 prevention, treatment, follow-up, and prognosis. A total of 24 informational pieces will be delivered, ensuring patients receive clear, research-based guidance to support their health management. This intervention aims to improve patient awareness and self-care strategies for Long Covid-19 and chronic conditions.

Other: Functional and cognitive rehabilitation strategy

Interventions

Functional and cognitive rehabilitation strategy OTHER

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.

Evidence-Based Informational Support

Evidence-Based Informational Support OTHER

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.

Functional and Cognitive Rehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Cardioinfantil Instituto de Cardiología: lead
• Hospital Militar Central, Colombia: collaborator

Study Sites (1)

Fundación Cardioinfantil-Instituto de cardiología

Bogotá, Bogotá DC, 110131, Colombia

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19; Noncommunicable Diseases; Hypertension; Diabetes Mellitus

Interventions

Functional Status

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; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Activities of Daily Living; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

Karen J Moreno, PT MSc

CONTACT

+6016672727; kmoreno@lacardio.org

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: Parallel-group, randomized controlled trial (RCT) with active control.

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-03

Locations

CO (1)