Counterpressure Maneuvers in Postural Orthostatic Tachycardia Syndrome (CPM_in_POTS)

Physical Counterpressure Maneuvers in Postural Orthostatic Tachycardia Syndrome (POTS) - a Monocentric, Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Postural Orthostatic Tachycardia Syndrome (POTS)
• Intervention / Treatment: Other: Best clinical practice; Behavioral: Best clinical practice plus CPM-biofeedback training

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alessandra Fanciulli, MD, PhD; Phone Number: +43 512 504 83238; Email: alessandra.fanciulli@i-med.ac.at

Study Locations

• Austria
  • Tirol
    • Innsbruck, Tirol, Austria, A-6020
      • Recruiting
      • Medical University of Innsbruck
      • Contact: Alessandra Fanciulli, MD, PhD; Phone Number: +43 512 504 83238; Email: alessandra.fanciulli@i-med.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Best clinical practice; Counselling on counterpressure maneuvers and other behavioral and non-pharmacological measures to combat POTS symptoms in daily life.	Other: Best clinical practice; Recommendations about life-style and behavioural measures to mitigate POTS symptoms in daily life.
Experimental: Best clinical practice plus CPM-biofeedback training; In addition to counselling on CPM and other behavioral and non-pharmacological measures to combat POTS symptoms in daily life, participants undergo a CPM-biofeedback training session in the autonomic function laboratory under continuous HR and BP monitoring.	Behavioral: Best clinical practice plus CPM-biofeedback training; The CPM-biofeedback training consists 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 per minute). All exercises will be performed under continuous heart rate and blood pressure monitoring to enable the study participants to gain feedbacks on the effect of the maneuvers on their own biosignals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Malmö Postural Orthostatic Tachycardia Syndrome symptom score (MAPS)	Baseline to day-14 change in the total score from 0 to 120. Higher scores means more symptoms and higher symptom severity.	Baseline to day-14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single items of the Malmö POTS Score (MAPS)	Baseline to day-14 change in twelve single items of the Malmö POTS Score (MAPS) from 0-10. Higher scores indicate more severe symptoms.	Baseline to day-14
Vanderbilt Orthostatic Symptom Score (VOSS)	Baseline to day-14 change in the 9 items Vanderbilt Orthostatic Symptom Score (VOSS, score range: 0-90). A higher score means more pronounced symptoms.	Baseline to day-14
Orthostatic Grading Scale (OGS)	Baseline to day-14 change in the 5-items Orthostatic Grading Scale (OGS, score range: 0-20). Higher scores mean more interference of daily life due to symptoms.	Baseline to day-14
Fatigue Severity Scale (FSS) - german Version	Baseline to day-14 change in the 9-items Fatigue Severity Scale (FSS) - german Version (score range: 1 to 63). Higher scores mean pronounced symptoms and worse outcome.	Baseline to day-14
European Quality of Life, 5 Dimensions, 5 Levels (EuroQol -EQ-5D-5L - german Version)	Baseline to day-14 change in the 5-items EuroQol -EQ-5D-5L - german Version and a 0-100 visual analogue scale. Higher scores means better outcome and self-estimated health, 100= best, 0= worse health.	Baseline to day-14
Estimated number and preferred choice of counterpressure maneuvers in daily life	Baseline to day-14 estimated number and preferred choice of counterpressure maneuver in daily life. Higher numbers indicate that a given counterpressure maneouver was performed more frequently, and stand for a better compliance.	Baseline to day-14
Overall usefulness of counterpressure maneuvers	Overall usefulness of counterpressure maneuvers on a Likert scale 0-10. Higher scores indicate higher subjective usefulness of a given counterpressure maneouver.	Baseline to day-14
Adverse events	Any adverse event from screening to day-14.	Screening-Visit to day-14
Barriers to counterpressure maneuver application in daily life	Barriers to counterpressure maneuver application in daily life in the opinion of the study participants. Open answers possible.	Baseline to day-14
Severity of orthostatic intolerance (on a 0 - 10 points scale)	Secondary in-laboratory endpoint, orthostatic intolerance after two minutes upon standing and performing counterpressure maneuvers compared to a baseline active standing for two minutes; higher score means more severe symptoms of orthostatic intolerance.	After performing four different counterpressure maneuvers for two minutes each during the biofeedback session, at day 1 +/-3.
Absolute heart rate	Absolute heart rate compared to baseline active standing.	At 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuver practiced upon standing , at day 1 +/-3.
Absolute systolic and diastolic blood pressure	Absolute systolic and diastolic blood pressure at 15, 30, 60, 90 and 120 seconds during counterpressure maneuver practiced upon standing compared to baseline active standing.	At 15, 30, 60, 90 and 120 seconds during counterpressure maneuver practiced upon standing, , at day 1 +/-3.
Supine-to-standing change in heart rate	Supine-to-standing change in heart rate at 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuver compared to baseline active standing (same timepoints)	At 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuvers, at day 1 +/-3.
Supine-to-standing change in systolic and diastolic blood pressure	Supine-to-standing change in systolic and diastolic blood pressure compared to baseline active standing at 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuvers	At 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuvers, at day 1 +/-3.

Collaborators and Investigators

• Sponsor: Medical University Innsbruck

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 28, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Nervous System Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease; Arrhythmias, Cardiac; Primary Dysautonomias; Autonomic Nervous System Diseases; Orthostatic Intolerance; Syndrome; Tachycardia; Postural Orthostatic Tachycardia Syndrome
• Other Study ID Numbers: 20241114-3611

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No