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NCT Number: NCT05890599

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Yoga therapy

Behavioral

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 Education

Behavioral

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.

Primary outcomes

  1. Fatigue

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Fatigue

    Time frame: 24 weeks

    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.

  2. Health related quality of life SF-12

    Time frame: 12 weeks

    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.

  3. Health related quality of life SF-12

    Time frame: 24 weeks

    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.

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

    Time frame: 12 weeks

    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.

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

    Time frame: 24 weeks

    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.

  6. Psychological symptoms

    Time frame: 12 weeks

    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.

  7. Psychological symptoms

    Time frame: 24 weeks

    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.

  8. Sleep quality

    Time frame: 12 weeks

    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.

  9. Sleep quality

    Time frame: 24 weeks

    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.

  10. Stress

    Time frame: 12 weeks

    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.

  11. Stress

    Time frame: 24 weeks

    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.

  12. Post-exertional malaise

    Time frame: 12 weeks

    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.

  13. Post-exertional malaise

    Time frame: 24 weeks

    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.

  14. Body awareness

    Time frame: 12 weeks

    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.

  15. Body awareness

    Time frame: 24 weeks

    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.

  16. Self-Efficacy

    Time frame: 12 weeks

    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.

  17. Self-Efficacy

    Time frame: 24 weeks

    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.

  18. Adverse events

    Time frame: Week 0, 1-12, 13 and 25

    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.

  19. C-reactive proteine

    Time frame: 12 weeks

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

  20. C-reactive proteine

    Time frame: 24 weeks

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

  21. Interleukine-6

    Time frame: 12 weeks

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

  22. Interleukine-6

    Time frame: 24 weeks

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

  23. D-dimer

    Time frame: 12 weeks

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

  24. D-dimer

    Time frame: 24 weeks

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

  25. Lactate dehydrogenase

    Time frame: 12 weeks

    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.

  26. Lactate dehydrogenase

    Time frame: 24 weeks

    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.

  27. Leukocytes and lymphocytes

    Time frame: 12 weeks

    Leukocytes and lymphocytes, from blood samples.

  28. Leukocytes and lymphocytes

    Time frame: 24 weeks

    Leukocytes and lymphocytes, from blood samples.

  29. Hand grip strength

    Time frame: 12 weeks

    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.

  30. Hand grip strength

    Time frame: 24 weeks

    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.

  31. Movement tracking

    Time frame: 12 weeks

    General tracking of patients' movement habits via activity monitor

  32. Movement tracking

    Time frame: 24 weeks

    General tracking of patients' movement habits via activity monitor

  33. Heart rate variability

    Time frame: 12 weeks

    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).

  34. Heart rate variability

    Time frame: 24 weeks

    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).

  35. Cost for Patient Questionnaire (CoPaQ)

    Time frame: 12 weeks, 24 weeks

    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.

Other outcomes

  1. Therapy rationale and therapy expectancy

    Time frame: Week 0

    The Credibility Expectancy Questionnaire (CEQ) published by Ametrano, et al. 2011 and validated as German version by Rieke, et al. 2013 is used to measure Therapierationale and Therapieerwartung at baseline. It measures these over 6 items using 9-point Likert scales.

  2. Personality dimensions

    Time frame: Week 0

    Big-Five-Inventory-10 (BFI-10) is used to assess personality dimensions based on the big-5 model.

  3. Qualitative Interviews

    Time frame: 12 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Holger Cramer, Professor

CONTACT

[email protected]

+49 711 8101 7858

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Charite University, Berlin, Germany
  • Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Registry information

Official study title

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

Acronym: YoFaPoCo

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 6, 2023
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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