This is a randomized, single-blind clinical trial that aims to evaluate the effectivenessof a therapeutic conscious movement program (including yoga, breathing exercises, andbody awareness) compared to conventional exercise (low-intensity strength and aerobictraining) and usual medical care (control group) over twelve weeks. The study is forpeople diagnosed with Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME) orPost-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 therapeutic conscious
movement program in individuals with Chronic Fatigue Syndrome/ Myalgic Encephalitis
(CFS/ME) or Post-Covid Syndrome (PCS). The study includes three parallel groups: (1)
therapeutic conscious movement (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.
Primary outcomes include fatigue levels (measured by the Chalder Fatigue Questionnaire)
and heart rate variability (HRV) as an indicator of autonomic function. Secondary
outcomes involve physical capacity, pain, sleep quality, mental health, interoceptive
awareness, quality of life, 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, the Doctoralia platform, 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: Therapeutic conscious movement
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: • 10 minutes of health education,
covering topics such as self-management and physical activity planning, mechanisms
through which exercise and awareness training can improve health status, guidance on how
to detect and work with bodily awareness, key concepts in proprioception and
interoception, and strategies for autonomous symptom regulation. • 35 minutes of
conscious movement 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:
- 10 minutes of health education, addressing topics such as self-management, physical
activity planning, mechanisms through which exercise can benefit health, and
strategies for autonomous symptom regulation.
- 35 minutes of 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)
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