Postural Orthostatic Tachycardia Syndrome (POTS)CPM_in_POTSNCT06936319
Counterpressure Maneuvers in Postural Orthostatic Tachycardia Syndrome
A study testing Best clinical practice plus CPM-biofeedback training and Best clinical practice in people with Postural Orthostatic Tachycardia Syndrome (POTS), run by Medical University Innsbruck at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postural Orthostatic Tachycardia Syndrome (POTS)
- What is being tested?
- Best clinical practice plus CPM-biofeedback training and Best clinical practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 15 Jan 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Innsbruck
Innsbruck, Tyrol, A-6020
Alessandra Fanciulli, MD, PhD, +43 512 504 83238, alessandra.fanciulli@i-med.ac.at
About this study
Official title: Physical Counterpressure Maneuvers in Postural Orthostatic Tachycardia Syndrome (POTS) - a Monocentric, Randomized Controlled 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.
Read more
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.
- Being tested
- Best clinical practice plus CPM-biofeedback training, Best clinical practice
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best clinical practice plus CPM-biofeedback trainingBehavioural
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 practiceOther
Recommendations about life-style and behavioural measures to mitigate POTS symptoms in daily life.
| Study group | Role | What they receive |
|---|---|---|
| Best clinical practice | Active comparator | Counselling on counterpressure maneuvers and other behavioral and non-pharmacological measures to combat POTS symptoms in daily life. Receives: 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. Receives: Behavioral: Best clinical practice plus CPM-biofeedback training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to day-14
Secondary outcomes (14)
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.
Measured: After performing four different counterpressure maneuvers for two minutes each during the biofeedback session, at day 1 +/-3.
Absolute heart rate
Absolute heart rate compared to baseline active standing.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to day-14
Adverse events
Any adverse event from screening to day-14.
Measured: 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.
Measured: Baseline to day-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start15 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural Orthostatic Tachycardia Syndrome (POTS)Studies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936319
- Sponsor's protocol ID
- 20241114-3611
- Acronym
- CPM_in_POTS
- Status last verified
- Mar 2025
- First submitted
- 28 Mar 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Counterpressure Maneuvers in Postural Orthostatic Tachycardia Syndrome (POTS) - a Monocentric, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06936319
- Acronym / sponsor ID
- CPM_in_POTS / 20241114-3611
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best clinical practice | Active comparator | Other: Best clinical practiceCounselling on counterpressure maneuvers and other behavioral and non-pharmacological measures to combat POTS symptoms in daily life. |
| Best clinical practice plus CPM-biofeedback training | Experimental | Behavioral: Best clinical practice plus CPM-biofeedback trainingIn 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best clinical practice plus CPM-biofeedback trainingThe 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. | Behavioural | Best clinical practice plus CPM-biofeedback training |
| Best clinical practiceRecommendations about life-style and behavioural measures to mitigate POTS symptoms in daily life. | Other | Best clinical practice |
Primary outcome
Malmö Postural Orthostatic Tachycardia Syndrome symptom score (MAPS)
Time frame: Baseline to day-14
Baseline to day-14 change in the total score from 0 to 120. Higher scores means more symptoms and higher symptom severity.
14 secondary outcomes
Severity of orthostatic intolerance (on a 0 - 10 points scale)
Time frame: After performing four different counterpressure maneuvers for two minutes each during the biofeedback session, at day 1 +/-3.
Absolute heart rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Baseline to day-14
Vanderbilt Orthostatic Symptom Score (VOSS)
Time frame: Baseline to day-14
Orthostatic Grading Scale (OGS)
Time frame: Baseline to day-14
Fatigue Severity Scale (FSS) - german Version
Time frame: Baseline to day-14
European Quality of Life, 5 Dimensions, 5 Levels (EuroQol -EQ-5D-5L - german Version)
Time frame: Baseline to day-14
Estimated number and preferred choice of counterpressure maneuvers in daily life
Time frame: Baseline to day-14
Overall usefulness of counterpressure maneuvers
Time frame: Baseline to day-14
Adverse events
Time frame: Screening-Visit to day-14
Barriers to counterpressure maneuver application in daily life
Time frame: Baseline to day-14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best clinical practice plus CPM-biofeedback training and Best clinical practice in people with Postural Orthostatic Tachycardia Syndrome (POTS), run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandra Fanciulli, MD, PhD (+43 512 504 83238, alessandra.fanciulli@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malmö Postural Orthostatic Tachycardia Syndrome symptom score (MAPS) (time frame: Baseline to day-14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.