Randomized Multicenter Clinical Trial: Yoga Versus Health Education for the Treatment of Persistent Fatigue in Patients With Post COVID-19 Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Fatigue
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Yoga Therapy
12 week yoga program, one weekly session of 90 minutes each, plus 2 times weekly 30 minutes of self practice.
Intervention: Yoga Therapy (Behavioral)
Health Education
12 week health education program, one weekly session of 90 minutes each, plus 2 times weekly 30 minutes of self practice.
Intervention: Health Education (Behavioral)
Outcomes
Primary Outcomes
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
- Hand grip strength(24 weeks)
- Lactate dehydrogenase(24 weeks)
- Leukocytes and lymphocytes(24 weeks)
- Movement tracking(24 weeks)
- Fatigue(24 weeks)
- Health related quality of life SF-12(24 weeks)
- Health related quality of life EQ-5D-5L(24 weeks)
- Psychological symptoms(24 weeks)
- Sleep quality(24 weeks)
- Stress(24 weeks)
- Post-exertional malaise(24 weeks)
- Self-Efficacy(24 weeks)
- Interleukine-6(24 weeks)
- D-dimer(24 weeks)
- Heart rate variability(24 weeks)
- Health related quality of life SF-12(24 weeks)
- Fatigue(24 weeks)
- Health related quality of life EQ-5D-5L(24 weeks)
- Psychological symptoms(24 weeks)
- Sleep quality(24 weeks)
- Stress(24 weeks)
- Post-exertional malaise(24 weeks)
- Body awareness(24 weeks)
- Self-Efficacy(24 weeks)
- Adverse events(Week 0, 1-12, 13 and 25)
- C-reactive proteine(24 weeks)
- Interleukine-6(24 weeks)
- D-dimer(24 weeks)
- Lactate dehydrogenase(24 weeks)
- Leukocytes and lymphocytes(24 weeks)
- Movement tracking(24 weeks)
- Heart rate variability(24 weeks)
- Cost for Patient Questionnaire (CoPaQ)(12 weeks, 24 weeks)
- Health related quality of life SF-12(12 weeks)
- Health related quality of life EQ-5D-5L(12 weeks)
- Psychological symptoms(12 weeks)
- Sleep quality(12 weeks)
- Stress(12 weeks)
- Post-exertional malaise(12 weeks)
- Body awareness(12 weeks)
- Self-Efficacy(12 weeks)
- C-reactive proteine(12 weeks)
- Interleukine-6(12 weeks)
- D-dimer(12 weeks)
- Lactate dehydrogenase(12 weeks)
- Leukocytes and lymphocytes(12 weeks)
- Hand grip strength(12 weeks)
- Movement tracking(12 weeks)
- Heart rate variability(12 weeks)