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Post-COVID-19 SyndromeYoFaPoCoNCT05890599

Yoga Versus Health Education for the Treatment of Persistent Fatigue in Patients With Post COVID-19 Syndrome

A study testing Yoga Therapy and Health Education in people with Post-COVID-19 Syndrome and Fatigue Post Viral, run by University Hospital Tuebingen at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Evaluation of the short- and medium-term effect of a yoga intervention in addition to routine care compared to health education in addition to routine care on fatigue in patients with post covid syndrome. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Post-COVID-19 Syndrome, Fatigue Post Viral
What is being tested?
Yoga Therapy and Health Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteGermany
Study dates
10 Jun 2023to 31 Mar 2026
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed COVID-19 diagnosis
  • Follow-up symptoms of ≥ 12 weeks
  • Persistent fatigue (scores ≥4 on the binomial Chalder Fatigue Scale).
  • Self-assessment that fatigue was a consequence of COVID-19 disease
  • Age 18-65 years

Who cannot join

  • Chronic medical conditions or regular use of medications associated with fatigue
  • Indication of health cause of fatigue other than post-COVID.
  • Indication of other factors as the main cause of fatigue
  • Physical limitations that do not allow participation in the yoga intervention
  • Pregnancy, breastfeeding
  • Concurrent participation in other clinical trials
  • Current yoga practice

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Germany1 site, 1 recruiting
  • Bosch-Health-Campus

    Stuttgart, 70376

    Recruiting

Other trials in Germany

About this study

Official title: Randomized Multicenter Clinical Trial: Yoga Versus Health Education for the Treatment of Persistent Fatigue in Patients With Post COVID-19 Syndrome

Evaluation of the short- and medium-term effect of a yoga intervention in addition to routine care compared to health education in addition to routine care on fatigue in patients with post covid syndrome.

Being tested
Yoga Therapy, Health Education
Keywords
Fatigue, Covid
Medical subject headings
Post-Acute COVID-19 Syndrome, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yoga TherapyBehavioural

    The range of interventions is based on previous studies on yoga interventions specifically for fatigue patients as well as on recommendations, for example, from the WHO. The yoga therapy includes 3 elements: yoga postures (asanas), breathing techniques (pranayama) and relaxation moments.

    Emphasis on postures and breathing techniques that are considered to be effective for fatigue symptoms, as well as specific breathing exercises to strengthen the respiratory muscles and increase lung volume.

  • Health EducationBehavioural

    Health education courses are conducted on-site once a week for 90 minutes over a 12-week period by a psychologist with clinical experience. The courses are didactic in nature and consist of lectures on topics of interest to patients with post-COVID syndrome and fatigue, followed by questions and discussion sessions. Topics include information on post-COVID syndrome and fatigue, an introduction to self-help for post-viral symptoms, psychosocial problems and fatigue, relaxation and stress management, nutrition, sleep hygiene, exercise, respecting one's own limits, acceptance, finding meaning, and achieving goals.

Study groups in NCT05890599
Study groupRoleWhat they receive
Yoga TherapyExperimental12 week yoga program, one weekly session of 90 minutes each, plus 2 times weekly 30 minutes of self practice.
Receives: Behavioral: Yoga Therapy
Health EducationActive comparator12 week health education program, one weekly session of 90 minutes each, plus 2 times weekly 30 minutes of self practice.
Receives: Behavioral: Health Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fatigue

    The chalder fatigue scale is used to assess the severity of fatigue within the last 4 weeks. It contains 11 questions in a four-step answer format (0-4), 7 of which refer to the degree of physical fatigue and 4 to the degree of mental fatigue. In its binomial evaluation (range 0-11) it can be used with a cut-off of (≥ 4) to divide patients into those with and those without fatigue.

    Measured: 12 weeks

Secondary outcomes (35)
  1. Fatigue

    The chalder fatigue scale is used to assess the severity of fatigue within the last 4 weeks. It contains 11 questions in a four-step answer format (0-4), 7 of which refer to the degree of physical fatigue and 4 to the degree of mental fatigue. In its binomial evaluation (range 0-11) it can be used with a cut-off of (≥ 4) to divide patients into those with and those without fatigue.

    Measured: 24 weeks

  2. Health related quality of life SF-12

    Short Form 12 Health Survey Questionnaire, The SF-12 represents the most commonly used instrument in clinical trials to assess generic quality of life. The questionnaire captures 8 different subscales, which are combined into a physical and a psychological summated scale.

    Measured: 12 weeks

  3. Health related quality of life SF-12

    Short Form 12 Health Survey Questionnaire, The SF-12 represents the most commonly used instrument in clinical trials to assess generic quality of life. The questionnaire captures 8 different subscales, which are combined into a physical and a psychological summated scale.

    Measured: 24 weeks

  4. Health related quality of life EQ-5D-5L

    The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. In this study, the EQ-5D-5L is used for cost-effectiveness analysis, together with healthcare-related costs.

    Measured: 12 weeks

  5. Health related quality of life EQ-5D-5L

    The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. In this study, the EQ-5D-5L is used for cost-effectiveness analysis, together with healthcare-related costs.

    Measured: 24 weeks

  6. Psychological symptoms

    The Hospital Anxiety and Depression Scale asks 14 questions, of which 7 are about anxiety and 7 about depression in patients with physical illnesses and physical complaints. More precisely, it measures the self-assessed severity of patients' anxious and depressive symptoms in relation to the past week.

    Measured: 12 weeks

  7. Psychological symptoms

    The Hospital Anxiety and Depression Scale asks 14 questions, of which 7 are about anxiety and 7 about depression in patients with physical illnesses and physical complaints. More precisely, it measures the self-assessed severity of patients' anxious and depressive symptoms in relation to the past week.

    Measured: 24 weeks

  8. Sleep quality

    The Pittsburgh Sleep Quality Index (PSQI) assesses the quality of sleep over the past 4 weeks using 24 questions, 17 for self-assessment and 7 for external assessment. It is used clinically to monitor patients with sleep disorders and to screen for sleep disorders in epidemiological studies. In this study, only the 17 self-assessment items are collected.

    Measured: 12 weeks

  9. Sleep quality

    The Pittsburgh Sleep Quality Index (PSQI) assesses the quality of sleep over the past 4 weeks using 24 questions, 17 for self-assessment and 7 for external assessment. It is used clinically to monitor patients with sleep disorders and to screen for sleep disorders in epidemiological studies. In this study, only the 17 self-assessment items are collected.

    Measured: 24 weeks

  10. Stress

    The current stress perception of the patients is assessed by means of the Perceived Stress Scale (PSS-10). This measures the current subjective perceived stress of the patients on the basis of 10 items.

    Measured: 12 weeks

  11. Stress

    The current stress perception of the patients is assessed by means of the Perceived Stress Scale (PSS-10). This measures the current subjective perceived stress of the patients on the basis of 10 items.

    Measured: 24 weeks

  12. Post-exertional malaise

    Post-exertional malaise (PEM) is a delayed worsening of symptoms that occurs after minimal physical or mental activity. The DePaul-Symptom Questionaire (DSQ) is used to asses PEM.

    Measured: 12 weeks

  13. Post-exertional malaise

    Post-exertional malaise (PEM) is a delayed worsening of symptoms that occurs after minimal physical or mental activity. The DePaul-Symptom Questionaire (DSQ) is used to asses PEM.

    Measured: 24 weeks

  14. Body awareness

    The Body Awareness Questionnaire (BAQ) assesses participants' subjective body awareness in four subdimensions: note responses or changes in body processes, predict bodily reaction, sleep-wake cycle, and onset of illness. The validated single-factor German version consists of 17 questions on a 7-point Likert scale from 1 (not at all true about me) to 7 (very true about me). The values of the individual items are added together to form a total score. Body awareness will be used in mediation analyses of treatment effects.

    Measured: 12 weeks

  15. Body awareness

    The Body Awareness Questionnaire (BAQ) assesses participants' subjective body awareness in four subdimensions: note responses or changes in body processes, predict bodily reaction, sleep-wake cycle, and onset of illness. The validated single-factor German version consists of 17 questions on a 7-point Likert scale from 1 (not at all true about me) to 7 (very true about me). The values of the individual items are added together to form a total score. Body awareness will be used in mediation analyses of treatment effects.

    Measured: 24 weeks

  16. Self-Efficacy

    The Arthritis Self-Efficacy Scale (ASES) was originally developed in 1989 as part of the Stanford Arthritis Self-Management Study to assess self-efficacy in arthritis patients and has since been used to assess it in many disease conditions. A short version (ASES-8/ASES-D) has been validated. This version surveys in scale level 1-10 the perceived ability to deal with occurring symptoms such as: Pain or fatigue. Self-efficacy will be used in mediation analyses of treatment effects.

    Measured: 12 weeks

  17. Self-Efficacy

    The Arthritis Self-Efficacy Scale (ASES) was originally developed in 1989 as part of the Stanford Arthritis Self-Management Study to assess self-efficacy in arthritis patients and has since been used to assess it in many disease conditions. A short version (ASES-8/ASES-D) has been validated. This version surveys in scale level 1-10 the perceived ability to deal with occurring symptoms such as: Pain or fatigue. Self-efficacy will be used in mediation analyses of treatment effects.

    Measured: 24 weeks

  18. Adverse events

    Adverse events and serious adverse events are documented. Adverse events include any adverse symptoms, illnesses, disorders, or accidents that occur during the course of the study. Serious adverse events include events occurring during the course of the study that are immediately life-threatening and/or result in serious health problems (specifically, requiring unanticipated hospitalization or prolongation of hospitalization, or resulting in serious disability or incapacitation). Adverse events (including PEM) and serious adverse events will be documented by participants on a weekly basis throughout the intervention period. Participants will be instructed to immediately notify the study site upon the occurrence of any serious adverse event. The severity as well as the possible causal relationship with the intervention will be assessed by the study physician.

    Measured: Week 0, 1-12, 13 and 25

  19. C-reactive proteine

    CRP as marker of pro-inflammatory cytokine activity, from blood samples.

    Measured: 12 weeks

  20. C-reactive proteine

    CRP as marker of pro-inflammatory cytokine activity, from blood samples.

    Measured: 24 weeks

  21. Interleukine-6

    IL-6, as marker of pro-inflammatory cytokine activity, from blood samples.

    Measured: 12 weeks

  22. Interleukine-6

    IL-6, as marker of pro-inflammatory cytokine activity, from blood samples.

    Measured: 24 weeks

  23. D-dimer

    D-dimer, as a by-product of the blood clotting and break-down process that can be measured via analysis of a blood sample

    Measured: 12 weeks

  24. D-dimer

    D-dimer, as a by-product of the blood clotting and break-down process that can be measured via analysis of a blood sample

    Measured: 24 weeks

  25. Lactate dehydrogenase

    Lactate dehydrogenase (LDH), measuring the amount of LDH in the blood. Lactate dehydrogenase is an enzyme that the body uses during the process of turning sugar into energy for your cells to use.

    Measured: 12 weeks

  26. Lactate dehydrogenase

    Lactate dehydrogenase (LDH), measuring the amount of LDH in the blood. Lactate dehydrogenase is an enzyme that the body uses during the process of turning sugar into energy for your cells to use.

    Measured: 24 weeks

  27. Leukocytes and lymphocytes

    Leukocytes and lymphocytes, from blood samples.

    Measured: 12 weeks

  28. Leukocytes and lymphocytes

    Leukocytes and lymphocytes, from blood samples.

    Measured: 24 weeks

  29. Hand grip strength

    Repeated measurement of hand strength can help detect physical decline and inflammatory processes Hand grip strength measurement can be an invaluable tool for monitoring physical performance decline.

    Measured: 12 weeks

  30. Hand grip strength

    Repeated measurement of hand grip strength can help detect physical decline and inflammatory processes Hand strength measurement can be an invaluable tool for monitoring physical performance decline.

    Measured: 24 weeks

  31. Movement tracking

    General tracking of patients' movement habits via activity monitor

    Measured: 12 weeks

  32. Movement tracking

    General tracking of patients' movement habits via activity monitor

    Measured: 24 weeks

  33. Heart rate variability

    24-hour measurement of heart rate variability (HRV) to determine the functionality of the participant's autonomic nervous system. A 3-channel ECG recorder (SRA/Multi-ECG recorder, SR-Medizinelektronik, Stuttgart, Germany) is used. Several HRV time-domain and HRV frequency-domain measures will be evaluated and analyzed for the total day and night (sleeping time) period as well as for 5-minutes-intervals within these two periods (SDNN, RMSSD, pNN50, SDANN, SDNNI, VLF power, LF power, HF power, LF/HF).

    Measured: 12 weeks

  34. Heart rate variability

    24-hour measurement of heart rate variability (HRV) to determine the functionality of the participant's autonomic nervous system. A 3-channel ECG recorder (SRA/Multi-ECG recorder, SR-Medizinelektronik, Stuttgart, Germany) is used. Several HRV time-domain and HRV frequency-domain measures will be evaluated and analyzed for the total day and night (sleeping time) period as well as for 5-minutes-intervals within these two periods (SDNN, RMSSD, pNN50, SDANN, SDNNI, VLF power, LF power, HF power, LF/HF).

    Measured: 24 weeks

  35. Cost for Patient Questionnaire (CoPaQ)

    Direct medical and non-medical costs are collected using this questionnaire. The questionnaire is a modified version of the Cost for Patient Questionnaire (CoPaQ), designed to collect all information on health care costs.

    Measured: 12 weeks, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2023
  2. Study start10 Jun 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Mar 2026 (estimated)

Resources

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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05890599
Sponsor's protocol ID
S00766-RBK
Acronym
YoFaPoCo
Status last verified
Jul 2025
First submitted
2 Jun 2023
Last updated
10 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cramer H, Morchen L, Vagedes J, Klenk J, Jager S, Schleinzer A, Anheyer D, Bilc M, Schroter M, Kessler C, Jeitler M. Yoga versus health education for persistent fatigue in patients with post-COVID-19 syndrome: protocol for a multicentre randomised controlled trial. BMJ Open. 2025 Oct 23;15(10):e107840. doi: 10.1136/bmjopen-2025-107840.

    PubMed 41130694

Questions about this trial

What is this clinical trial studying?

A study testing Yoga Therapy and Health Education in people with Post-COVID-19 Syndrome and Fatigue Post Viral, run by University Hospital Tuebingen at 1 site in Germany.

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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 10 Jul 2025. 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 Germany. 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?

Contact Holger Cramer, Professor (+49 711 8101 7858, yasemin.anguelov@bosch-health-campus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fatigue (time frame: 12 weeks). 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 NCT05890599, which also lists 1 linked publication.

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 10 Jul 2025.

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