University of Seville
Hermann Fricke Comellas
This is a randomized, single-blind clinical trial that aims to evaluate the effectiveness of a therapeutic conscious movement program (including 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.
Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME)
Post COVID Syndrome
Therapeutic conscious movement
Conventional exercise
NA
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 147 participants |
| Masking : | SINGLE |
| Masking Description : | Statistician |
| Primary Purpose : | TREATMENT |
| Official Title : | Effectiveness of a Therapeutic Yoga and Interoception Program vs Traditional Exercise on Fatigue and Related Variables in Patients With Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME) or Post Covid Syndrome (PCS) |
| Actual Study Start Date : | 2025-10-01 |
| Estimated Primary Completion Date : | 2027-04-30 |
| Estimated Study Completion Date : | 2027-09-30 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 70 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Faculty of Nursing, Physiotherapy and Podiatry. University of Seville (Macarena Campus, pellets)
Sevilla, Spain, 41009