Evaluating the Impact of a Functional and Cognitive Strategy in Patients With Long Covid-19 (NCT06871293) | Clinical Trial Compass
RecruitingNot Applicable
Evaluating the Impact of a Functional and Cognitive Strategy in Patients With Long Covid-19
Colombia374 participantsStarted 2025-10-30
Plain-language 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. 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ca…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite Change in Functional Capacity, Cognitive Function, Health-Related Quality of Life, and Strength
Timeframe: Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.
Trial details
NCT IDNCT06871293
SponsorFundación Cardioinfantil Instituto de Cardiología