Yoga Versus Health Education for the Treatment of Persistent Fatigue in Patients With Post COVID-19 Syndrome
YoFaPoCo
Randomized Multicenter Clinical Trial: Yoga Versus Health Education for the Treatment of Persistent Fatigue in Patients With Post COVID-19 Syndrome
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2023
CompletedFirst Posted
Study publicly available on registry
June 6, 2023
CompletedStudy Start
First participant enrolled
June 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedJuly 10, 2025
July 1, 2025
2.6 years
June 2, 2023
July 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
12 weeks
Secondary Outcomes (35)
Fatigue
24 weeks
Health related quality of life SF-12
12 weeks
Health related quality of life SF-12
24 weeks
Health related quality of life EQ-5D-5L
12 weeks
Health related quality of life EQ-5D-5L
24 weeks
- +30 more secondary outcomes
Other Outcomes (3)
Therapy rationale and therapy expectancy
Week 0
Personality dimensions
Week 0
Qualitative Interviews
12 weeks
Study Arms (2)
Yoga Therapy
EXPERIMENTAL12 week yoga program, one weekly session of 90 minutes each, plus 2 times weekly 30 minutes of self practice.
Health Education
ACTIVE COMPARATOR12 week health education program, one weekly session of 90 minutes each, plus 2 times weekly 30 minutes of self practice.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bosch-Health-Campus
Stuttgart, 70376, Germany
Related Publications (1)
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.
PMID: 41130694DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Holger Cramer, Professor
University Hospital Tübingen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2023
First Posted
June 6, 2023
Study Start
June 10, 2023
Primary Completion
December 31, 2025
Study Completion
March 31, 2026
Last Updated
July 10, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share