Counterpressure Maneuvers in Postural Orthostatic Tachycardia Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMedical University Innsbruck
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Best clinical practice plus CPM-biofeedback training
BehavioralThe 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
Other interventionRecommendations about life-style and behavioural measures to mitigate POTS symptoms in daily life.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Best clinical practiceActive comparator 1 intervention
Group B: Best clinical practice plus CPM-biofeedback trainingExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline to day-14Secondary outcomes
1
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.
Time frame
After performing four different counterpressure maneuvers for two minutes each during the biofeedback session, at day 1 +/-3.2
Absolute heart rate
Absolute heart rate compared to baseline active standing.
Time frame
At 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuver practiced upon standing , at day 1 +/-3.3
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.
Time frame
At 15, 30, 60, 90 and 120 seconds during counterpressure maneuver practiced upon standing, , at day 1 +/-3.4
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)
Time frame
At 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuvers, at day 1 +/-3.Sponsors and contacts
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Source ClinicalTrials.gov