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

NCT06978582 | Active Not Recruiting

• 1 other identifier: 2025-0180
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

exercise movement techniques; Chronic Fatigue Syndrome; Post COVID Syndrome; mind-body therapies; exercise; pacing; Telerehabilitation

Outcome Measures

Primary Outcomes (1)

• Fatigue

  Fatigue will be measured through the Spanish version of the Chadler Fatigue Scale. It is a 14-item psychometric questionnaire designed to assess the subjective perception of physical and mental fatigue over the past few weeks. Items are rated on a 4-point Likert scale (0 = never, 1 = sometimes, 2 = often, 3 = always). The total score ranges from 0 to 42, with higher scores indicating greater levels of fatigue.

  From baseline to three months after intervention completion

Secondary Outcomes (10)

• Heart Rate Variability

  From baseline to three months after intervention completion

• Perceived pain

  From baseline to three months after intervention completion

• Perceived Quality of life

  From baseline to three months after intervention completion

• Physical function

  From baseline to three months after intervention completion

• Interoceptive awareness

  From baseline to three months after intervention completion

Study Arms (3)

Mindful and conscious movement-based exercise

EXPERIMENTAL

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.

Behavioral: Mindful and conscious movement-based exercise

Conventional exercise

ACTIVE COMPARATOR

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.

Behavioral: Conventional exercise

Control

NO INTERVENTION

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.

Interventions

Mindful and conscious movement-based exercise 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.

Mindful and conscious movement-based exercise

Conventional exercise 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.

Conventional exercise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

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

Seville, Sevilla, 41009, Spain

Location

Related Publications (2)

• 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.

  PMID: 39451436 BACKGROUND

• Fricke-Comellas H, Infante-Cano M, Heredia-Rizo AM, Martin-Fernandez A, Escudero-Perez P, Fernandez-Seguin LM. Safety and Effectiveness of an Exercise-Based Telerehabilitation Program in Myalgic Encephalomyelitis and Post COVID Syndrome: Protocol for a Randomized Controlled Clinical Trial. Healthcare (Basel). 2025 Nov 26;13(23):3062. doi: 10.3390/healthcare13233062.

  PMID: 41373279 DERIVED

Related Links

• Information and contact to participate in the study

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Hermann Fricke-Comellas, Principal Investigator

  University of Seville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 18, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The IPD will be available from the initial protocol registration till the final study publication.
• Access Criteria: The information will be available by contacting the principal investigator.

Locations

ES (1)