NCT06936319 Counterpressure Maneuvers in Postural Orthostatic Tachycardia Syndrome
| NCT ID | NCT06936319 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University Innsbruck |
| Condition | Postural Orthostatic Tachycardia Syndrome (POTS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-01-15 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-01-15 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 CPM in 40 individuals suffering from POTS. All study participants will receive detailed counselling on CPM and other behavioral and non-pharmacological measures to combat POTS symptoms in daily life and will be invited to practice them regularly (best clinical practice). Participants randomized to the interventional arm will receive a CPM-biofeedback training session in the autonomic function laboratory at the Department of Neurology of the Innsbruck Medical University to learn four different CPM under continuous HR and BP monitoring. The CPM-biofeedback training will consist of a baseline 2-minutes active standing and the following four different physical maneuver: leg crossing and muscle tensing, heel raises (10 tiptoeing per minute), squatting, unilateral handgrip (20 times a minute). The trial foresees three study visits for both the interventional and the control arm (screening and baseline on-site, as well as a telephone visit 14 days later). For the interventional trial arm, two additional visits are planned (CPM-biofeedback training session in the autonomic function laboratory and a follow-up telephone visit 7 days later). To evaluate the baseline to day-14 change in symptom severity, the Malmö POTS Score (MAPS) total score (primary endpoint) and the MAPS single items, Vanderbilt Orthostatic Symptom Score, Orthostatic Grading Scale, Fatigue Severity Scale and Health-related Quality of Life Questionnaire (EuroQol -EQ-5D-5L ) will be administered.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06936319 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Postural Orthostatic Tachycardia Syndrome (POTS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06936319 currently recruiting?
Yes, NCT06936319 is actively recruiting participants. Contact the research team at alessandra.fanciulli@i-med.ac.at for enrollment information.
Where is the NCT06936319 trial being conducted?
This trial is being conducted at Innsbruck, Austria.
Who is sponsoring the NCT06936319 clinical trial?
NCT06936319 is sponsored by Medical University Innsbruck. The trial plans to enroll 40 participants.