About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Yoga TherapyExperimental treatment 1 intervention

Group B: Health EducationActive comparator 1 intervention

Trial outcomes

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.

Time frame

12 weeks

Secondary 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.

Time frame

24 weeks

2

Health related quality of life SF-12

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.

Time frame

12 weeks

3

Health related quality of life SF-12

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.

Time frame

24 weeks

4

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

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.

Time frame

12 weeks

Other outcomes

1

Therapy rationale and therapy expectancy

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.

Time frame

Week 0

2

Personality dimensions

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

Time frame

Week 0

3

Qualitative Interviews

Time frame

12 weeks

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts