Effectiveness and Safety of a Tele-Rehabilitation Program on Fatigue and Related Variables in Chronic Fatigue Syndrome and Post COVID Syndrome

NCT ID: NCT06978582

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-09-30

Brief 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.

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindful and conscious movement-based exercise

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Conventional exercise

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Seville

OTHER

Sponsor Role: lead

Responsible Party

Hermann Fricke Comellas

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hermann Fricke-Comellas, Principal Investigator

Role: PRINCIPAL_INVESTIGATOR

University of Seville

Locations

Facultad de Enfermería, Fisioterapia y Podología. Universidad de Sevilla (Campus Macarena, Perdigones)

Seville, Sevilla, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Hermann Fricke-Comellas, Principal Investigator

Role: CONTACT

hfricke@us.es

+34 672279589

Alberto M Heredia-Rizo, Clinical Professor

Role: CONTACT

amheredia@us.es

+34 687823894

Facility Contacts

Hermann Fricke-Comellas, PT, MSc

Role: primary

hfricke@us.es

+34 672279589

References

Fricke-Comellas H, Heredia-Rizo AM, Casuso-Holgado MJ, Salas-Gonzalez J, Fernandez-Seguin LM. Exploring the Effects of Qigong, Tai Chi, and Yoga on Fatigue, Mental Health, and Sleep Quality in Chronic Fatigue and Post-COVID Syndromes: A Systematic Review with Meta-Analysis. Healthcare (Basel). 2024 Oct 11;12(20):2020. doi: 10.3390/healthcare12202020.

Reference Type: BACKGROUND

PMID: 39451436 (View on PubMed)

Related Links

https://drive.google.com/drive/folders/1Ge5fJfv5MBSOUL1kSaSC1c_kAUESfZ1F?usp=share_link

Information and contact to participate in the study

Other Identifiers

2025-0180

Identifier Type: -

Identifier Source: org_study_id