Clinical trial NCT06936319: Counterpressure Maneuvers in Postural Orthostatic Tachycardia Syndrome
Official title: Physical Counterpressure Maneuvers in Postural Orthostatic Tachycardia Syndrome (POTS) - a Monocentric, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postural Orthostatic Tachycardia Syndrome (POTS)
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Malmö Postural Orthostatic Tachycardia Syndrome symptom score (MAPS)
timeFrame: Baseline to day-14
Secondary outcomes:
measure: Severity of orthostatic intolerance (on a 0 - 10 points scale)
timeFrame: After performing four different counterpressure maneuvers for two minutes each during the biofeedback session, at day 1 +/-3.
measure: Absolute heart rate
timeFrame: At 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuver practiced upon standing , at day 1 +/-3.
measure: Absolute systolic and diastolic blood pressure
timeFrame: At 15, 30, 60, 90 and 120 seconds during counterpressure maneuver practiced upon standing, , at day 1 +/-3.
measure: Supine-to-standing change in heart rate
timeFrame: At 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuvers, at day 1 +/-3.
measure: Supine-to-standing change in systolic and diastolic blood pressure
timeFrame: At 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuvers, at day 1 +/-3.
measure: Single items of the Malmö POTS Score (MAPS)
timeFrame: Baseline to day-14
measure: Vanderbilt Orthostatic Symptom Score (VOSS)
timeFrame: Baseline to day-14
measure: Orthostatic Grading Scale (OGS)
timeFrame: Baseline to day-14
measure: Fatigue Severity Scale (FSS) - german Version
timeFrame: Baseline to day-14
measure: European Quality of Life, 5 Dimensions, 5 Levels (EuroQol -EQ-5D-5L - german Version)
timeFrame: Baseline to day-14
measure: Estimated number and preferred choice of counterpressure maneuvers in daily life
timeFrame: Baseline to day-14
measure: Overall usefulness of counterpressure maneuvers
timeFrame: Baseline to day-14
measure: Adverse events
timeFrame: Screening-Visit to day-14
measure: Barriers to counterpressure maneuver application in daily life
timeFrame: Baseline to day-14
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
state: Tirol
Study officials:
References: