Active — Not RecruitingNot Applicable

Effectiveness and Safety of a Tele-Rehabilitation Program on Fatigue and Related Variables in Chronic Fatigue Syndrome and Post COVID Syndrome

Spain147 participantsStarted 2025-10-01

Plain-language 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 yoga, breathing exercises, and body awareness) compared to conventional exercise (low-intensity strength and aerobic training) and usual medical care (control group) over twelve weeks. The study is for people diagnosed with Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME) or Post-Covid Syndrome (PCS). We will also look at how the program affects the autonomic nervous system by measuring heart rate variability (HRV). All sessions will be delivered remotely via Telehealth, so participants can take part from home. Assessments will be completed online at the beginning of the study, after three months (at the end of the intervention), and again three months later.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion Criteria: * 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 Criteria: * 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.

What they're measuring

Fatigue

Timeframe: From baseline to three months after intervention completion

Trial details

NCT IDNCT06978582

SponsorUniversity of Seville

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-30

View on ClinicalTrials.gov More Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME) trials