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 range

18 Years – 70 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: * 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.

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

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