Clinical trial NCT05890599: Yoga Versus Health Education for the Treatment of Persistent Fatigue in Patients With Post COVID-19 Syndrome
Official title: Randomized Multicenter Clinical Trial: Yoga Versus Health Education for the Treatment of Persistent Fatigue in Patients With Post COVID-19 Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-COVID-19 Syndrome
Fatigue Post Viral
Keywords: Fatigue
Covid
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Robert Bosch Gesellschaft für Medizinische Forschung mbH
name: Charite University, Berlin, Germany
First posted: 2023-06-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fatigue
timeFrame: 12 weeks
Secondary outcomes:
measure: Fatigue
timeFrame: 24 weeks
measure: Health related quality of life SF-12
timeFrame: 12 weeks
measure: Health related quality of life SF-12
timeFrame: 24 weeks
measure: Health related quality of life EQ-5D-5L
timeFrame: 12 weeks
measure: Health related quality of life EQ-5D-5L
timeFrame: 24 weeks
measure: Psychological symptoms
timeFrame: 12 weeks
measure: Psychological symptoms
timeFrame: 24 weeks
measure: Sleep quality
timeFrame: 12 weeks
measure: Sleep quality
timeFrame: 24 weeks
measure: Stress
timeFrame: 12 weeks
measure: Stress
timeFrame: 24 weeks
measure: Post-exertional malaise
timeFrame: 12 weeks
measure: Post-exertional malaise
timeFrame: 24 weeks
measure: Body awareness
timeFrame: 12 weeks
measure: Body awareness
timeFrame: 24 weeks
measure: Self-Efficacy
timeFrame: 12 weeks
measure: Self-Efficacy
timeFrame: 24 weeks
measure: Adverse events
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 24 weeks
measure: C-reactive proteine
timeFrame: 12 weeks
measure: C-reactive proteine
timeFrame: 24 weeks
measure: Interleukine-6
timeFrame: 12 weeks
measure: Interleukine-6
timeFrame: 24 weeks
measure: D-dimer
timeFrame: 12 weeks
measure: D-dimer
timeFrame: 24 weeks
measure: Lactate dehydrogenase
timeFrame: 12 weeks
measure: Lactate dehydrogenase
timeFrame: 24 weeks
measure: Leukocytes and lymphocytes
timeFrame: 12 weeks
measure: Leukocytes and lymphocytes
timeFrame: 24 weeks
measure: Grip strength
timeFrame: 12 weeks
measure: Grip strength
timeFrame: 24 weeks
measure: Movement tracking
timeFrame: 12 weeks
measure: Movement tracking
timeFrame: 24 weeks
measure: Heart rate variability
timeFrame: 12 weeks
measure: Heart rate variability
timeFrame: 24 weeks
Other outcomes:
measure: Therapy rationale and therapy expectancy
timeFrame: Week 1
measure: Personality dimensions
timeFrame: Week 1
Locations:
city: Stuttgart
country: Germany
facility: Bosch-Health-Campus
Study officials:
affiliation: University Hospital Tübingen
name: Holger Cramer, Professor
role: STUDY_DIRECTOR
References: