Status:
RECRUITING
Effectiveness and Safety of a Tele-Rehabilitation Program on Fatigue and Related Variables in Chronic Fatigue Syndrome and Post COVID Syndrome
Lead Sponsor:
University of Seville
Conditions:
Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME)
Post COVID Syndrome
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This is a randomized, single-blind clinical trial that aims to evaluate the effectiveness of a tele-rehabilitation program based on mindful and conscious movement-based exercise (including adapted yog...
Detailed Description
This clinical trial aims to evaluate the effectiveness of a tele-rehabilitation program based on mindful and conscious movement-based exercise (MBE) in individuals with Chronic Fatigue Syndrome/ Myalg...
Eligibility Criteria
Inclusion
- Participants must be over 18 and under 70 years of age (to minimize the presence of comorbidities).
- Participants must meet the latest established diagnostic criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Post-Covid Syndrome, respectively.
- Participants must have access to a computer, tablet, or mobile device with an internet connection to attend videoconference sessions.
- Participants must have a mobile device compatible with the applications Cardiio: Heart Rate Monitor and Welltory, which will be used to measure heart rate (HR) and heart rate variability (HRV), respectively.
- Participants must be able to remain seated in a chair for at least 45 continuous minutes.
- Participants must have fluent comprehension of the Spanish language.
- Any comorbid condition that could explain the symptomatology associated with the syndrome (such as post-infectious organ damage, heart disease, neurological disorders, cancer, severe psychiatric illness, or metabolic syndrome) must have been ruled out by a physician.
Exclusion
- Recent suspicion of comorbid conditions that could explain the syndrome's associated symptoms, not yet ruled out by a qualified healthcare professional.
- Inability to use basic software required for participation in the study (e.g., Microsoft Teams, completing a Google Forms questionnaire).
- Unwillingness to make minor adjustments to daily habits.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT06978582
Start Date
October 1 2025
End Date
September 30 2027
Last Update
October 3 2025
Active Locations (1)
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1
Facultad de Enfermería, Fisioterapia y Podología. Universidad de Sevilla (Campus Macarena, Perdigones)
Seville, Sevilla, Spain, 41009