Counterpressure Maneuvers in Postural Orthostatic Tachycardia Syndrome

NCT ID: NCT06936319

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2025-12-31

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Best clinical practice

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

Group Type: ACTIVE_COMPARATOR

Best clinical practice

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Best clinical practice plus CPM-biofeedback training

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Best clinical practice

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of Innsbruck

Innsbruck, Tyrol, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Alessandra Fanciulli, MD, PhD

Role: CONTACT

alessandra.fanciulli@i-med.ac.at

+43 512 504 83238

Facility Contacts

Alessandra Fanciulli, MD, PhD

Role: primary

alessandra.fanciulli@i-med.ac.at

+43 512 504 83238

Other Identifiers

20241114-3611

Identifier Type: -

Identifier Source: org_study_id