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

NCT ID: NCT05890599

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-10

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post-COVID-19 Syndrome Fatigue Post Viral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Yoga Therapy

12 week yoga program, one weekly session of 90 minutes each, plus 2 times weekly 30 minutes of self practice.

Group Type EXPERIMENTAL

Yoga Therapy

Intervention Type 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

12 week health education program, one weekly session of 90 minutes each, plus 2 times weekly 30 minutes of self practice.

Group Type ACTIVE_COMPARATOR

Health Education

Intervention Type 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.

Interventions

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Yoga Therapy

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.

Intervention Type BEHAVIORAL

Health Education

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Holger Cramer, Professor

Role: STUDY_DIRECTOR

University Hospital Tübingen

Locations

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Bosch-Health-Campus

Stuttgart, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Holger Cramer, Professor

Role: CONTACT

+49 711 8101 7858

References

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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.

Reference Type DERIVED
PMID: 41130694 (View on PubMed)

Other Identifiers

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S00766-RBK

Identifier Type: -

Identifier Source: org_study_id

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