Counterpressure Maneuvers in Postural Orthostatic Tachycardia Syndrome

NCT06936319 | Recruiting

• 1 other identifier: 20241114-3611
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Postural Orthostatic Tachycardia Syndrome (POTS)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Severity of orthostatic intolerance (on a 0 - 10 points scale)

  After performing four different counterpressure maneuvers for two minutes each during the biofeedback session, at day 1 +/-3.

• Absolute heart rate

  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

  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

  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

  At 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuvers, at day 1 +/-3.

Study Arms (2)

Best clinical practice

ACTIVE COMPARATOR

Counselling on counterpressure maneuvers and other behavioral and non-pharmacological measures to combat POTS symptoms in daily life.

Other: Best clinical practice

Best clinical practice plus CPM-biofeedback training

EXPERIMENTAL

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

Interventions

Best clinical practice plus CPM-biofeedback training BEHAVIORAL

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.

Best clinical practice plus CPM-biofeedback training

Best clinical practice OTHER

Recommendations about life-style and behavioural measures to mitigate POTS symptoms in daily life.

Best clinical practice

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• POTS diagnosis
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University of Innsbruck

Innsbruck, Tyrol, A-6020, Austria

RECRUITING

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Alessandra Fanciulli, MD, PhD

CONTACT

+43 512 504 83238; alessandra.fanciulli@i-med.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 20, 2025
• Study Start: January 15, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-03

Locations

AU (1)