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

Post-COVID-19 Syndrome Clinical Trial

— YoFaPoCo  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05890599
• Other study ID #: S00766-RBK
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2023
• Est. completion date: November 2024

Study information

• Verified date: January 2023
• Source: University Hospital Tuebingen
• Contact: Holger Cramer, Professor
• Phone: +49 711 8101 7858
• Email: yasemin.anguelov[@]bosch-health-campus.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Fatigue
• Fatigue Post Viral
• Post-COVID-19 Syndrome
• Syndrome

Intervention

Behavioral:
• 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.
• Health Education
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.

Locations

Country	Name	City	State
Germany	Bosch-Health-Campus	Stuttgart

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Charite University, Berlin, Germany, Robert Bosch Gesellschaft für Medizinische Forschung mbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Week 1
Other	Personality dimensions	Big-Five-Inventory-10 (BFI-10) is used to assess personality dimensions based on the big-5 model.	Week 1
Primary	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	Fatigue	Chalder Fatigue Scale	24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	C-reactive proteine	CRP as marker of pro-inflammatory cytokine activity, from blood samples.	12 weeks
Secondary	C-reactive proteine	CRP as marker of pro-inflammatory cytokine activity, from blood samples.	24 weeks
Secondary	Interleukine-6	IL-6, as marker of pro-inflammatory cytokine activity, from blood samples.	12 weeks
Secondary	Interleukine-6	IL-6, as marker of pro-inflammatory cytokine activity, from blood samples.	24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Leukocytes and lymphocytes	Leukocytes and lymphocytes, from blood samples.	12 weeks
Secondary	Leukocytes and lymphocytes	Leukocytes and lymphocytes, from blood samples.	24 weeks
Secondary	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
Secondary	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
Secondary	Movement tracking	General tracking of patients' movement habits via activity monitor	12 weeks
Secondary	Movement tracking	General tracking of patients' movement habits via activity monitor	24 weeks
Secondary	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
Secondary	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