This is a randomized, single-blind clinical trial that aims to evaluate the effectivenessof a tele-rehabilitation program based on mindful and conscious movement-based exercise(including adapted yoga, breathing exercises, and body awareness) compared toconventional exercise (low-intensity strength and aerobic training) and usual medicalcare (control group) over twelve weeks. The study is for people diagnosed with ChronicFatigue Syndrome/ Myalgic Encephalitis (CFS/ME) or Post-Covid Syndrome (PCS).We will also look at how the program affects the autonomic nervous system by measuringheart rate variability (HRV).All sessions will be delivered remotely via Telehealth, so participants can take partfrom home. Assessments will be completed online at the beginning of the study, afterthree months (at the end of the intervention), and again three months later.
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/ Myalgic Encephalitis (CFS/ME) or Post-Covid Syndrome (PCS). The study
includes three parallel groups: (1) MBE (including yoga, breathwork, and interoceptive
awareness); (2) conventional low-intensity aerobic and strength exercise; and (3) usual
medical care as a control. Participants will be randomly assigned to one of the three
groups in a 1:1:1 ratio.
All interventions will be delivered via Telehealth, allowing participants to follow the
program from home, which increases accessibility and is especially important for people
experiencing severe fatigue. The intervention period will last 12 weeks. Both the
conscious movement program and the conventional exercise program include a weekly live
session of 45 minutes, progressively increased by 5 minutes per month to adapt to
tolerance and avoid post-exertional symptom exacerbation. The program is designed with
special attention to pacing, allowing participants to self-regulate effort levels based
on daily condition and feedback from the body. Participants will also engage in a
supportive WhatsApp group and complete digital daily logs.
The primary outcome is fatigue level (measured by the Chalder Fatigue Questionnaire).
Secondary outcomes involve heart rate variability (HRV) as an indicator of autonomic
function, physical capacity, pain, sleep quality, mental health, interoceptive awareness,
quality of life, pain-related fear and somatic vigilance, adverse events, and adherence
to the intervention. Assessment points are: baseline (T0), 3 months, at the end of
intervention (T1), and follow-up at 6 months (T2). The study follows CONSORT guidelines
and is single-blinded (evaluators/statisticians blinded to group assignment).
The expected sample size is 147 participants (49 per group), calculated for sufficient
statistical power and accounting for 20% dropout. Recruitment will occur through patient
associations, social media, and clinical collaborators. Data analysis will follow an
intention-to-treat approach using appropriate mixed models for repeated measures.
The study addresses the need for safe and feasible therapeutic options for people with
post-viral fatigue syndromes. It also explores the potential role of interoception and
vagal modulation in symptom relief, contributing to a growing body of research on
holistic, home-based interventions for chronic conditions.
Behavioral: Mindful and conscious movement-based exercise
The program will last for 12 weeks and will consist of one weekly 45-minute session, with
an additional 5 minutes of exercise added each month: • 15 minutes of health education.
Educational content will focus on self-management, pacing, planning of activity and rest,
basic theoretical framework about the conditions, and familiarization with mindful and
awareness practices and their purported benefits. • 30 minutes of conscious
movement-based exercise practice, increasing by 5 minutes each month and guided by pacing
recommendations. Additionally, participants will be encouraged to engage in at least 15
minutes of daily practice with the support of recorded material.
Behavioral: Conventional exercise
The program will last for 12 weeks and will consist of one weekly 45-minute session, with
an additional 5 minutes of exercise added each month:
- 15 minutes of health education. Educational content will now focus on
self-management, pacing, planning of activity and rest, basic theoretical framework
about the conditions, and the rationale for the impact of exercise in symptom
management.
- 30 minutes of low intensity strength and aerobic exercise practice, with session
duration progressively increased by increasing by 5 minutes each month and guided by
pacing recommendations.
Additionally, participants will be encouraged to engage in at least 15 minutes of daily
practice with the support of recorded material.
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.
Facultad de Enfermería, Fisioterapia y Podología. Universidad de Sevilla (Campus Macarena, Perdigones)
Seville 2510911, Sevilla, Spain
Investigator: Hermann Fricke-Comellas, PT, MSc
Contact: +34 672279589
hfricke@us.es
Investigator: Hermann Fricke-Comellas, PT, MSc
Hermann Fricke-Comellas, Principal Investigator
+34 672279589
hfricke@us.es
Alberto M Heredia-Rizo, Clinical Professor
+34 687823894
amheredia@us.es
Hermann Fricke-Comellas, Principal Investigator, Principal Investigator
University of Seville