Counterpressure Maneuvers in Postural Orthostatic Tachycardia Syndrome

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.
• Другое Best clinical practice
  Recommendations about life-style and behavioural measures to mitigate POTS symptoms in daily life.

Первичные конечные точки

• Malmö Postural Orthostatic Tachycardia Syndrome symptom score (MAPS) [Срок оценки: Baseline to day-14]

Вторичные конечные точки (12)

• Severity of orthostatic intolerance (on a 0 - 10 points scale) [Срок оценки: After performing four different counterpressure maneuvers for two minutes each during the biofeedback session, at day 1 +/-3.]
• Absolute heart rate [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: At 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuvers, at day 1 +/-3.]
• Single items of the Malmö POTS Score (MAPS) [Срок оценки: Baseline to day-14]
• Vanderbilt Orthostatic Symptom Score (VOSS) [Срок оценки: Baseline to day-14]
• Orthostatic Grading Scale (OGS) [Срок оценки: Baseline to day-14]
• Fatigue Severity Scale (FSS) - german Version [Срок оценки: Baseline to day-14]
• European Quality of Life, 5 Dimensions, 5 Levels (EuroQol -EQ-5D-5L - german Version) [Срок оценки: Baseline to day-14]
• Estimated number and preferred choice of counterpressure maneuvers in daily life [Срок оценки: Baseline to day-14]
• Overall usefulness of counterpressure maneuvers [Срок оценки: Baseline to day-14]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Австрия · 1 центр

• Medical University of Innsbruck — Innsbruck

Идентификаторы

NCT: NCT06936319 · 20241114-3611

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗