Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME)NCT06978582
Effectiveness and Safety of a Tele-Rehabilitation Program on Fatigue and Related Variables in Chronic Fatigue Syndrome and Post COVID Syndrome
A study testing Mindful and conscious movement-based exercise and Conventional exercise in people with Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME) and Post COVID Syndrome, run by University of Seville at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME), Post COVID Syndrome
- What is being tested?
- Mindful and conscious movement-based exercise and Conventional exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2025to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site
Facultad de Enfermería, Fisioterapia y Podología. Universidad de Sevilla (Campus Macarena, Perdigones)
Seville, Sevilla, 41009
About this study
Official title: 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)
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.
Read the 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.
- Being tested
- Mindful and conscious movement-based exercise, Conventional exercise
- Keywords
- exercise movement techniques, Chronic Fatigue Syndrome, Post COVID Syndrome, mind-body therapies, exercise, pacing, Telerehabilitation
- Medical subject headings
- Fatigue Syndrome, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful and conscious movement-based exerciseBehavioural
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 exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to three months after intervention completion
Secondary outcomes (10)
Heart Rate Variability
Welltory Mobile Application (v.4.16.100) is a mobile application that uses photoplethysmography through the phone's camera to measure resting heart rate. Based on these data, it estimates heart rate variability (HRV) parameters, including autonomic balance indicators such as RMSSD and SSDN. The tool has been validated in previous studies for assessing resting HRV, showing a significant correlation with reference medical devices such as electrocardiograms and heart rate monitors (intraclass correlation coefficient > 0.90).
Measured: From baseline to three months after intervention completion
Perceived pain
Perceived pain will be assessed through the Spanish version of the Brief Pain Inventory (BPI), which is a self-administered instrument composed of two sections: pain intensity and the degree of interference in daily activities (such as sleep, mood, work, among others). It consists of 9 items, each rated on a numerical scale from 0 to 10, where higher scores indicate greater pain intensity and/or interference.
Measured: From baseline to three months after intervention completion
Perceived Quality of life
Perceived quality of life will be assessed through the completion of the Spanish version of the SF-36 Health Questionary. It is a widely used tool for measuring health-related quality of life. This instrument consists of 36 items grouped into eight dimensions: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores are transformed to a scale from 0 to 100 for each dimension, with higher scores indicating a better perceived health status in that domain.
Measured: From baseline to three months after intervention completion
Physical function
Physical function will be quantified through the Sit-To-Stand Test. This test is a functional test that measures lower limb muscular endurance. It involves recording the number of repetitions of standing up from and sitting down on a standard armless chair over a 60-second period. The participant must keep their arms crossed over the chest and perform the movement as quickly as possible while maintaining proper technique. This test is a reliable indicator of functional strength and muscular endurance, widely used in both healthy populations and individuals with chronic conditions.
Measured: From baseline to three months after intervention completion
Interoceptive awareness
Interoceptive awareness will be quantified through the Spanish version of the Multidimensional Assessment of Interoceptive Awareness. This is a self-administered 32-item questionnaire that measures interoceptive awareness across eight dimensions, such as attention to internal bodily sensations, emotional regulation through bodily signals, and interoceptive confidence. Each item is rated on a Likert scale from 0 (never) to 5 (always), with higher scores indicating greater interoceptive awareness.
Measured: From baseline to three months after intervention completion
Anxiety and depression levels
Anxiety and depression levels will be measured with the Hospital Anxiety and Depression Scale (HADS) which is a brief questionnaire composed of 14 items divided into two subscales: anxiety (7 items) and depression (7 items). Each item is rated on a scale from 0 to 3, with total scores ranging from 0 to 21 for each subscale. A cutoff score of ≥8 is considered indicative of clinically significant levels of anxiety or depression.
Measured: From baseline to three months after intervention completion
Perceived sleep quality
Perceived sleep quality will be measured with the Pittsburg Sleep Quality Index (PSQI). This is a self-administered questionnaire that assesses sleep quality over the past month. It consists of 19 items grouped into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3, and the total score ranges from 0 to 21. Scores greater than 5 indicate significant sleep problems.
Measured: From baseline to three months after intervention completion
Fear of movement
Fear of movement will be measured through the Tampa Scale for Kinesiophobia. The Tampa Scale for Kinesiophobia assesses fear of movement related to pain through 17 items rated on a 4-point Likert scale (1 = strongly disagree, 4 = strongly agree). Total scores range from 17 to 68, with higher scores indicating greater levels of kinesiophobia.
Measured: From baseline to three months after intervention completion
Somatic vigilance
Somatic vigilance will be evaluated using the Anxiety Sensitivity Index (ASI; Spanish version). The ASI consists on 16 items (total score 0-64) assessing fear of anxiety-related bodily sensations, with higher scores denoting greater sensitivity.
Measured: From baseline to three months after intervention completion
Treatment feasibility
Treatment feasibility will be measured through quantification of adherence to treatment and adverse events. An individual digital diary will be used to record this data.
Measured: From baseline to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Oct 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hermann Fricke Comellas, University of Seville
- Investigators
- Hermann Fricke-Comellas, Principal Investigator, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978582
- Sponsor's protocol ID
- 2025-0180
- Status last verified
- Apr 2026
- First submitted
- 14 May 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only data included in the final study publication will be shared, in accordance with the recommendations of the institutional ethics committee
Publications
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.
PubMed 39451436Fricke-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.
PubMed 41373279
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06978582
- Acronym / sponsor ID
- 2025-0180
- Keywords
- exercise movement techniques, Chronic Fatigue Syndrome, Post COVID Syndrome, mind-body therapies, exercise, pacing, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindful and conscious movement-based exercise | Experimental | Behavioral: Mindful and conscious movement-based exerciseThe 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. |
| Conventional exercise | Active comparator | Behavioral: Conventional exerciseThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful and conscious movement-based exerciseThe 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. | Behavioural | Mindful and conscious movement-based exercise |
| Conventional exerciseThe 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. | Behavioural | Conventional exercise |
Primary outcome
Fatigue
Time frame: From baseline to three months after intervention completion
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.
10 secondary outcomes
Heart Rate Variability
Time frame: From baseline to three months after intervention completion
Perceived pain
Time frame: From baseline to three months after intervention completion
Perceived Quality of life
Time frame: From baseline to three months after intervention completion
Physical function
Time frame: From baseline to three months after intervention completion
Interoceptive awareness
Time frame: From baseline to three months after intervention completion
Anxiety and depression levels
Time frame: From baseline to three months after intervention completion
Perceived sleep quality
Time frame: From baseline to three months after intervention completion
Fear of movement
Time frame: From baseline to three months after intervention completion
Somatic vigilance
Time frame: From baseline to three months after intervention completion
Treatment feasibility
Time frame: From baseline to the end of treatment at 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background: PubMed 39451436Fricke-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.
- Derived from this study: PubMed 41373279Fricke-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.
- Information and contact to participate in the studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Only data included in the final study publication will be shared, in accordance with the recommendations of the institutional ethics committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hermann Fricke-Comellas, Principal Investigator principal investigator
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful and conscious movement-based exercise and Conventional exercise in people with Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME) and Post COVID Syndrome, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: From baseline to three months after intervention completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06978582, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.