Effectiveness of a Therapeutic Yoga Program on Fatigue and Related Variables in Patients With Chronic Fatigue Syndrome or Long Covid

University of Seville

Status: Enrolling

Conditions: Post COVID Syndrome; Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME)

Treatments: Behavioral: Conventional exercise; Behavioral: Therapeutic conscious movement

Study type: Interventional

Funder types: Other

Identifiers

NCT06978582

2025-0180

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 147 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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147 participants in 3 patient groups

Therapeutic conscious movement

Experimental group

Description:

The intervention will be based on 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.

Treatment:

Behavioral: Therapeutic conscious movement

Conventional exercise

Active Comparator group

Description:

The intervention will be based on 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.

Treatment:

Behavioral: Conventional exercise

Control

No Intervention group

Description:

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.