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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Best clinical practice | Active Comparator | Counselling on counterpressure maneuvers and other behavioral and non-pharmacological measures to combat POTS symptoms in daily life. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandra Fanciulli, MD, PhD | Contact | +43 512 504 83238 | alessandra.fanciulli@i-med.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Innsbruck | Recruiting | Innsbruck | Tyrol | A-6020 | Austria |
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| ID | Term |
|---|---|
| D054972 | Postural Orthostatic Tachycardia Syndrome |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Best clinical practice | Other | Recommendations about life-style and behavioural measures to mitigate POTS symptoms in daily life. |
|
| 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. |
| 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 |