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

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.

Official Title
-----------------
Randomized Multicenter Clinical Trial: Yoga Versus Health Education for the Treatment of Persistent Fatigue in Patients With Post COVID-19 Syndrome

Conditions
-----------------
Post-COVID-19 Syndrome, Fatigue Post Viral

Intervention / Treatment
-----------------
* Behavioral: Yoga Therapy
* Behavioral: Health Education


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga Therapy<br>12 week yoga program, one weekly session of 90 minutes each, plus 2 times weekly 30 minutes of self practice. | Behavioral: Yoga Therapy<br>* 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.<br>|
| Active Comparator: Health Education<br>12 week health education program, one weekly session of 90 minutes each, plus 2 times weekly 30 minutes of self practice. | Behavioral: Health Education<br>* Health education courses are conducted on-site once a week for 90 minutes over 12 weeks 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Chalder Fatigue Scale | 24 weeks | 
| 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. | 12 weeks | 
| 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. | 24 weeks | 
| 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. | 12 weeks | 
| 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. | 24 weeks | 
| Psychological symptoms | The Hospital Anxiety and Depression Scale asks 14 questions, of which 7 are about anxiety and 7 about depression in patients with physical illnesses and physical complaints. More precisely, it measures the self-assessed severity of patients' anxious and depressive symptoms in relation to the past week. | 12 weeks | 
| Psychological symptoms | The Hospital Anxiety and Depression Scale asks 14 questions, of which 7 are about anxiety and 7 about depression in patients with physical illnesses and physical complaints. More precisely, it measures the self-assessed severity of patients' anxious and depressive symptoms in relation to the past week. | 24 weeks | 
| Sleep quality | The Pittsburgh Sleep Quality Index (PSQI) assesses the quality of sleep over the past 4 weeks using 24 questions, 17 for self-assessment and 7 for external assessment. It is used clinically to monitor patients with sleep disorders and to screen for sleep disorders in epidemiological studies. | 12 weeks | 
| Sleep quality | The Pittsburgh Sleep Quality Index (PSQI) assesses the quality of sleep over the past 4 weeks using 24 questions, 17 for self-assessment and 7 for external assessment. It is used clinically to monitor patients with sleep disorders and to screen for sleep disorders in epidemiological studies. | 24 weeks | 
| Stress | The current stress perception of the patients is assessed by means of the Perceived Stress Scale (PSS-10). This measures the current subjective perceived stress of the patients on the basis of 10 items. | 12 weeks | 
| Stress | The current stress perception of the patients is assessed by means of the Perceived Stress Scale (PSS-10). This measures the current subjective perceived stress of the patients on the basis of 10 items. | 24 weeks | 
| Post-exertional malaise | Post-exertional malaise (PEM) is a delayed worsening of symptoms that occurs after minimal physical or mental activity. The DePaul-Symptom Questionaire (DSQ) is used to asses PEM. | 12 weeks | 
| Post-exertional malaise | Post-exertional malaise (PEM) is a delayed worsening of symptoms that occurs after minimal physical or mental activity. The DePaul-Symptom Questionaire (DSQ) is used to asses PEM. | 24 weeks | 
| Body awareness | The BAQ is an 18-item scale designed to assess self-reported attentiveness to normal nonemotive body processes, specifically, sensitivity to body cycles and rhythms, ability to detect small changes in normal functioning, and ability to anticipate bodily reactions. Body awareness will be used in mediation analyses of treatment effects. | 12 weeks | 
| Body awareness | The BAQ is an 18-item scale designed to assess self-reported attentiveness to normal nonemotive body processes, specifically, sensitivity to body cycles and rhythms, ability to detect small changes in normal functioning, and ability to anticipate bodily reactions. Body awareness will be used in mediation analyses of treatment effects. | 24 weeks | 
| Self-Efficacy | The Arthritis Self-Efficacy Scale (ASES) was originally developed in 1989 as part of the Stanford Arthritis Self-Management Study to assess self-efficacy in arthritis patients and has since been used to assess it in many disease conditions. A short version (ASES-8/ASES-D) has been validated. This version surveys in scale level 1-10 the perceived ability to deal with occurring symptoms such as: Pain or fatigue. Self-efficacy will be used in mediation analyses of treatment effects. | 12 weeks | 
| Self-Efficacy | The Arthritis Self-Efficacy Scale (ASES) was originally developed in 1989 as part of the Stanford Arthritis Self-Management Study to assess self-efficacy in arthritis patients and has since been used to assess it in many disease conditions. A short version (ASES-8/ASES-D) has been validated. This version surveys in scale level 1-10 the perceived ability to deal with occurring symptoms such as: Pain or fatigue. Self-efficacy will be used in mediation analyses of treatment effects. | 24 weeks | 
| Adverse events | Adverse events and serious adverse events are documented. Adverse events include any adverse symptoms, illnesses, disorders, or accidents that occur during the course of the study. Serious adverse events include events occurring during the course of the study that are immediately life-threatening and/or result in serious health problems (specifically, requiring unanticipated hospitalization or prolongation of hospitalization, or resulting in serious disability or incapacitation). The severity as well as the possible causal relationship with the intervention will be assessed by the study physician. | 12 weeks | 
| Adverse events | Adverse events and serious adverse events are documented. Adverse events include any adverse symptoms, illnesses, disorders, or accidents that occur during the course of the study. Serious adverse events include events occurring during the course of the study that are immediately life-threatening and/or result in serious health problems (specifically, requiring unanticipated hospitalization or prolongation of hospitalization, or resulting in serious disability or incapacitation). The severity as well as the possible causal relationship with the intervention will be assessed by the study physician. | 24 weeks | 
| C-reactive proteine | CRP as marker of pro-inflammatory cytokine activity, from blood samples. | 12 weeks | 
| C-reactive proteine | CRP as marker of pro-inflammatory cytokine activity, from blood samples. | 24 weeks | 
| Interleukine-6 | IL-6, as marker of pro-inflammatory cytokine activity, from blood samples. | 12 weeks | 
| Interleukine-6 | IL-6, as marker of pro-inflammatory cytokine activity, from blood samples. | 24 weeks | 
| D-dimer | D-dimer, as a by-product of the blood clotting and break-down process that can be measured via analysis of a blood sample | 12 weeks | 
| D-dimer | D-dimer, as a by-product of the blood clotting and break-down process that can be measured via analysis of a blood sample | 24 weeks | 
| Lactate dehydrogenase | Lactate dehydrogenase (LDH), measuring the amount of LDH in the blood. Lactate dehydrogenase is an enzyme that the body uses during the process of turning sugar into energy for your cells to use. | 12 weeks | 
| Lactate dehydrogenase | Lactate dehydrogenase (LDH), measuring the amount of LDH in the blood. Lactate dehydrogenase is an enzyme that the body uses during the process of turning sugar into energy for your cells to use. | 24 weeks | 
| Leukocytes and lymphocytes | Leukocytes and lymphocytes, from blood samples. | 12 weeks | 
| Leukocytes and lymphocytes | Leukocytes and lymphocytes, from blood samples. | 24 weeks | 
| Grip strength | Repeated measurement of hand strength can help detect physical decline and inflammatory processes Hand strength measurement can be an invaluable tool for monitoring physical performance decline. | 12 weeks | 
| Grip strength | Repeated measurement of hand strength can help detect physical decline and inflammatory processes Hand strength measurement can be an invaluable tool for monitoring physical performance decline. | 24 weeks | 
| Movement tracking | General tracking of patients' movement habits via activity monitor | 12 weeks | 
| Movement tracking | General tracking of patients' movement habits via activity monitor | 24 weeks | 
| Heart rate variability | HRV is simply a measure of the variation in time between each heartbeat. This variation is controlled by a primitive part of the nervous system called the autonomic nervous system (ANS). It works behind the scenes, automatically regulating our heart rate, blood pressure, breathing, and digestion among other key tasks. | 12 weeks | 
| Heart rate variability | HRV is simply a measure of the variation in time between each heartbeat. This variation is controlled by a primitive part of the nervous system called the autonomic nervous system (ANS). It works behind the scenes, automatically regulating our heart rate, blood pressure, breathing, and digestion among other key tasks. | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fatigue, Covid