Effectiveness and Safety of a Tele-rehabilitation Program Based on Mindful and Conscious Movement-based Exercise vs Conventional Low-intensity Exercise on Fatigue and Related Variables in Patients With Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME) or Post COVID Syndrome (PCS)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Facultad de Enfermería, Fisioterapia y Podología. Universidad de Sevilla (Campus Macarena, Perdigones)
RECRUITING
Seville
Contact Information
Primary
Hermann Fricke-Comellas, Principal Investigator
hfricke@us.es
+34 672279589
Backup
Alberto M Heredia-Rizo, Clinical Professor
amheredia@us.es
+34 687823894
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 147
Treatments
Experimental: Mindful and conscious movement-based exercise
The intervention will be based on adapted yoga, meditation, breathing exercises, and proprioceptive awareness, in addition to the medical recommendations and pharmacological treatment prescribed by the general practitioner or specialist overseeing each case. 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. Additionally, participants will be encouraged to engage in at least 15 minutes of daily practice with the support of recorded material.
Active_comparator: Conventional exercise
The intervention will be based on low-intensity aerobic and strength exercise, in addition to the medical recommendations and prescribed pharmacological treatment provided by the participant's general practitioner or specialist. 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. Additionally, participants will be encouraged to engage in at least 15 minutes of daily practice with the support of recorded material.
No_intervention: Control
The control group will continue with their usual medical care and will not participate in either of the two interventions until all assessments are completed. After the final evaluation, participants in this group will be offered the choice to receive either of the two interventions and will be provided with the corresponding recorded materials.
Sponsors
Leads: University of Seville

This content was sourced from clinicaltrials.gov