Evaluating counterpressure maneuvers for treating Postural Orthostatic Tachycardia Syndrome
Physical Counterpressure Maneuvers in Postural Orthostatic Tachycardia Syndrome (POTS) - a Monocentric, Randomized Controlled Trial
NA · Medical University Innsbruck · NCT06936319
This study is testing if a new training method called counterpressure maneuvers can help people with Postural Orthostatic Tachycardia Syndrome feel better and improve their daily lives.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Medical University Innsbruck (other) |
| Locations | 1 site (Innsbruck, Tyrol) |
| Trial ID | NCT06936319 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a 14-day counterpressure maneuvers (CPM) biofeedback training in alleviating symptoms of Postural Orthostatic Tachycardia Syndrome (POTS). Participants will be randomly assigned to receive either the CPM training alongside best clinical practice or best clinical practice alone. The study aims to assess improvements in symptom burden, daily activity interference, fatigue, and quality of life, as well as the hemodynamic effects of CPM on heart rate and blood pressure. Safety and tolerability of the intervention will also be evaluated.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 80 diagnosed with POTS who are stable on their medication.
Not a fit: Patients with acute infections, recent surgeries, or those on vasoactive medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients suffering from POTS.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Innsbruck, Tyrol
- Medical University of Innsbruck — Innsbruck, Tyrol, Austria (RECRUITING)
Study contacts
- Study coordinator: Alessandra Fanciulli, MD, PhD
- Email: alessandra.fanciulli@i-med.ac.at
- Phone: +43 512 504 83238
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postural Orthostatic Tachycardia Syndrome