Pilot-case-control study on exertion and orthostatic intolerance of adolescents with myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS) compared to age-matched healthy controls (HC).
ME/CFS is a complex disease. Symptoms include orthostatic intolerance (OI) such as postural tachycardia syndrome (PoTS). PoTS in ME/CFS can significantly impair everyday function and social participation. Yet, data in affected adolescents are rare and inconsistent. This pilot-case-control study study aimed at characterizing OI in adolescents aged 14-17 years with ME/CFS and age-adapted HC, comparing the results with other clinical features of both such as exertion intolerance, fatigue, and health-related quality of life, and suggesting a standardized tool for diagnostics. ME/CFS was diagnosed according to the Clinical Canadian Criteria (CCC 2003), criteria of the former Institute of Medicine (IOM 2015), the diagnostic work sheet developed by Rowe 2017, and/or the pediatric case suggested by Jason 2006. Questionnaires were used to evaluate symptoms (e.g. post-exertional malaise, fatigue, anxiety, depression), and health-related quality of life. A standardized specific interview was performed to assess the medical history of OI (HOI). Heart rate (HR) and blood pressure were evaluated every minute during a passive 10-min standing test (NASA lean test) in the morning with empty stomach and without morning medication. Data were evaluated according to the PoTS criteria defined in 2019 at the National Institutes of Health Expert Consensus Meeting and by the International Classification of Diseases (ICD-11) (8D89.2). Frequency and type of OI, including PoTS, were examined in both groups and outcomes compared to parameters from questionnaires. Based on the results, novel standards for OI diagnostics were suggested.
Study Type
OBSERVATIONAL
Enrollment
40
MRI Chronic Fatigue Center for Young People (MCFC) Children's Hospital, Technical University of Munich & Munich Municipal Hospital Munich
Munich, Bavaria, Germany
Heart Rate during Passive 10-min. standing test
Heart rate during Passive 10-Min. standing test (NASA lean test)
Time frame: one time point during study from study start until study completion, approximately 1 year
Blood Pressure during Passive 10-min. standing test
blood pressure, pulse pressure (calculated by systolic and diastolic blood pressure) during Passive 10-Min. standing test (NASA lean test)
Time frame: one time point during study from study start until study completion, approximately 1 year
Symptoms during Passive 10-Min. standing test
Symptoms during Passive 10-Min. standing test (NASA lean test): Yes/No
Time frame: one time point during study from study start until study completion, approximately 1 year
O2-Saturation during Passive 10-Min. standing test
O2-Saturation during Passive 10-Min. standing test (NASA lean test)
Time frame: one time point during study from study start until study completion, approximately 1 year
Presence of Orthostatic Intolerance: Semistructured Interview
Semistructured Interview, History of Orthostatic Intolerance (OI): Yes/No
Time frame: one time point during study from study start until study completion, approximately 1 year
Number of orthostatic Symptoms: Semistructured Interview
Semistructured Interview, Number of Symptoms
Time frame: one time point during study from study start until study completion, approximately 1 year
Number of participants with a diagnosis of PoTS, Orthostatic Intolerance and related diagnoses
History of OI and Nasa lean test together result in an orthostatic diagnosis, Fulfilling of PoTS-Criteria at study visit is evaluated
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Time frame: one time point during study from study start until study completion, approximately 1 year
Presence of ME/CFS-specific Symptoms (Munich Berlin Symptom Questionnaire)
Questionnaire: number of relevant symptoms. Likert Scale "0-4" of severity and frequency for each symptom: A symptom is relevant with a severity and frequency of each at least "2" on the Likert Scale. Minimum: 0 relevant symptoms (best), Maximum: 60 relevant symptoms (worst).
Time frame: one time point during study from study start until study completion, approximately 1 year
Presence of Post-exertional malaise (DePaul Symptom Questionnaire -Post exertional Malaise: DSQ-PEM)
Questionnaire, Binary Outcome: Post-exertional Malaise Yes/No
Time frame: one time point during study from study start until study completion, approximately 1 year
Self-estimated level of Quality of Life: EQ-5D-5L: Index
Questionnaire: Index (0 worst - 1 best)
Time frame: one time point during study from study start until study completion, approximately 1 year
Self-estimated level of Quality of Life: EQ-5D-5L: Visual Analog Scale
Visual Analog Scale (0 worst - 100 best)
Time frame: one time point during study from study start until study completion, approximately 1 year
Screening via Public Health Questionnaire-4 (PHQ-4)
Ultra-Short-4-item-Screening for Anxiety/Depression: Scale (0 Symptom occurs never - 3 Symptom occurs almost every day)
Time frame: one time point during study from study start until study completion, approximately 1 year
Malmö PoTS Score (MAPS)
Orthostatic Symptoms Severity, Scale (0 no symptom burden - 120 highest symptom burden)
Time frame: one time point during study from study start until study completion, approximately 1 year
Levels of serum antibodies against EBV
Levels of Autoantibodies at study visit
Time frame: one time point during study from study start until study completion, approximately 1 year
Levels of serum antibodies against SARS-CoV-2
Levels of autoantibodies at study visit
Time frame: one time point during study from study start until study completion, approximately 1 year
Levels of serum autoantibodies
Levels of autoantibodies at study visit
Time frame: one time point during study from study start until study completion, approximately 1 year