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Counterpressure Maneuvers in Postural Orthostatic Tachycardia Syndrome

RecruitingNAAges 18 Years - 80 YearsAllMedical University Innsbruck
NCT06936319 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The present study evaluates whether performing a 14-days counter pressure maneuvers (CPM)-biofeedback training improves the symptomatic burden (primary objective) and secondarily the interference of POTS symptoms with daily activities, fatigue, and health-related quality of life of individuals with POTS compared to best clinical practice non-pharmacological measures. Secondary in-laboratory objectives are to assess the influence of CPM on the supine-to-standing heart rate (HR) and blood pressure (BP) changes as well as on the severity of orthostatic intolerance after performing CPM for two minutes compared to a baseline (intervention-free) active standing test, and to assess the safety and tolerability of CPM-biofeedback training in individuals with POTS. This is a monocentric, proof-of-concept, 1:1 randomized, controlled trial with rater-blinded evaluation of the hemodynamic effect of

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📋 Eligibility rules (as published)
Inclusion Criteria: * POTS diagnosis * 18 to 80 years of age at time of consent * stable medication in the seven days prior to the baseline visit * able to provide written informed consent Exclusion Criteria: * participation in other interventional trials * pregnant or breastfeeding females * on treatment with vasoactive medications including medications for heart rate control * acute infections at the time of enrolment or in the two weeks before * acute pain * surgery in the last three months * inability or contraindication for performing hip and knee flexion, hip adduction or squatting * inability to stand for at least two minutes * Any other cardiological, internal, psychiatric or neurological condition, which may prevent engagement in the sturdy procedures in the judgement of the investigator
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What it tests

  • Best clinical practice plus CPM-biofeedback training
  • Best clinical practice
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Where

1 site
Medical University of Innsbruck
Innsbruck, Austria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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