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

Sponsor
Fundación Cardioinfantil Instituto de Cardiología
Study ID
NCT06871293
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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 — 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.

Study Details

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.

Key Dates

First listed
Mar 11, 2025
Start date
Oct 30, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
374 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Functional and Cognitive Rehabilitation
    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.
  • Active Comparator: Evidence-Based Informational Support
    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.

Primary Outcome Measure

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

Central Contacts

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