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Hemodynamic Effects of Compression in POTS

Body Compression in Postural Tachycardia Syndrome (POTS): Effects on Orthostatic Tolerance

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03484273
Enrollment
32
Registered
2018-03-30
Start date
2018-07-12
Completion date
2021-01-26
Last updated
2021-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postural Tachycardia Syndrome

Keywords

Tilt Table, Compression, Dysautonomia, POTS

Brief summary

When an individual with Postural Tachycardia Syndrome (POTS) stands up, their heart rate increases significantly (\>30BPM) and they may experience symptoms such as lightheadedness, dizziness, shortness of breath, nausea and mental confusion. One commonly prescribed treatment for POTS is compression garments. Compression garments squeeze veins to help return blood back to the heart, which may decrease heart rate and symptoms on standing. However, there is little research about the effectiveness of compression in adults with POTS. In this study, the investigators will use the Lifewrap garment, which compresses the abdomen, pelvis and lower extremities, to evaluate the effectiveness of compression in POTS. The investigators will use a head up tilt (HUT) which will simulate standing. The study participant will participate in 4x 10 minute HUTs wearing 4 different compression configurations: 1. full abdomen and lower extremity compression 2. abdominal only compression 3. leg only compression 4. No compression The investigators hypothesize that with full compression, the participant's heart rate increase from lying down to upright will be lower than when they are not wearing any compression. The investigators will also ask the participant about their symptoms when they are upright. The results of this study could demonstrate the potential benefits of compression and what configuration is most effective. These findings could rapidly translate to the clinical setting, providing improved care.

Detailed description

Postural Tachycardia Syndrome (POTS) is a chronic form of orthostatic intolerance marked by a significant and sustained increase in heart rate (HR) upon positional change from supine to standing (\>30 beats/min \[bpm\]) in the absence of orthostatic hypotension (\<20/10 mmHg decrease). Symptoms must be present for \>6 months and other causes of orthostatic tachycardia must be ruled out. Individuals with POTS report orthostatic symptoms including palpitations, lightheadedness, and mental clouding, which improve on recumbence. The vast majority of individuals diagnosed with POTS are women age 13-50 years. Upon standing, approximately 500 mL of blood immediately redistributes from the thorax down to the abdomen, buttocks and legs. This leads to sympathetic activation as the baroreceptors sense less pressure. In a healthy individual, HR initially increases 10-20 bpm, and the systolic blood pressure (BP) decreases by approximately 5 mmHg. However, in an individual with POTS, this compensatory mechanism is impaired and HR will increase by \>30 bpm and remain at this elevated rate for the duration of standing. In some individuals with POTS, upon standing cerebral blood flow velocity decreases. In other individuals, oscillation of cerebral blood flow due to failure of cerebral autoregulatory mechanisms is observed. Current treatment of POTS involves pharmacological and non-pharmacological intervention including salt and fluid loading, exercise, and physical countermanuevers. There are no approved medications for use in POTS and all use is off label. Compression garments are also often prescribed. Abdominal/lower extremity compression garments provide pressure to the blood vessels in the legs, thighs and abdomen which can minimize blood pooling and lead to improved blood return to the heart. One such garment is the Lifewrap Non-pneumatic AntiShock garment (NASG), indicated in post-partum hypovolemia. A pediatric study (n=20) found that orthostatic tachycardia and symptoms were decreased during head up tilt (HUT), with the use of a different NASG compression garment vs. no compression. However, there is no data to validate the efficacy of compression in adults POTS, and also no data to determine which type of compression is most beneficial (e.g. lower leg only, abdomen only, combination). The investigators hypothesize that the use of the Lifewrap NASG compression garment in a fully applied configuration will decrease orthostatic tachycardia and orthostatic symptoms during a 10 minute HUT vs. no compression garment. The investigators will complete a 4-way randomized crossover study of HUTs with compression applied by the LifeWrap NSAG in at attempt to demonstrate decreased orthostatic tachycardia and increased orthostatic tolerance in individuals with POTS. If successful, this study could provide needed evidence that compression in POTS is a successful non-pharmacological treatment modality, and as well, what type of compression is the most beneficial to patients with this syndrome. These findings could rapidly translate to the clinical setting and improve patient care. The study participant will complete 4x 10min HUTs during a single study day. There will be 4 compression conditions based on strap configuration of the Lifewrap garment: (1) full abdominal and lower extremity compression, (2) abdominal only compression, (3) lower extremity only compression and (4) no compression. A pressure sensor will used to measure the magnitude of compression pressure applied. The study will be conducted on a tilt table in a human physiology research and procedure room. Each intervention phase in the protocol will involve a supine baseline assessment period of 10 minutes followed by a 10 min HUT (80 degrees). There will be a 20 min recovery periods between each HUT. The study will take approximately 4 hours. The study participant will be instrumented in a fasting state and on an empty bladder. The investigators will apply skin electrodes to continuously monitor heart rate and record an ECG. BP will be monitored continuously using a finger volume clamp method (Nexfin, Edwards Lifesciences) and calibrated with intermittent brachial cuff measurements (Vital-Guard 450C Patient Care Monitor, IVY Medical). From the continuous BP waveform, the investigators can obtain an estimate of stroke volume, cardiac output, and systemic vascular resistance (Modelflow). Middle cerebral blood flow velocity will be assessed using transcranial doppler.

Interventions

DEVICELifeWrap Compression Garment

Non-Pneumatic Anti-Shock (NASG) compression garment comprised of neoprene with velcro closures.

Sponsors

University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

There will be 4 compression conditions based on strap configuration of the Lifewrap garment: full abdominal and lower extremity compression, abdominal only compression, lower extremity only compression and no compression. The order of these interventions will be randomized.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Physician diagnosis of Postural Tachycardia Syndrome (POTS) * Age 18-60 years (we are an adult group and we do not see pediatric patients clinically and do not have appropriate pediatric expertise) * Male and Female * Able and willing to provide informed consent * Ability to travel to Libin Cardiovascular Institute of Alberta Autonomic Testing Lab at the University of Calgary, Calgary, AB.

Exclusion criteria

* Overt cause for postural tachycardia, i.e., acute dehydration * Participants with somatization or severe anxiety symptoms will be excluded (as they may not tolerated study procedures) * Pregnant women * Inability to tolerate compression garment for the duration of the study * Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies

Design outcomes

Primary

MeasureTime frameDescription
Orthostatic Heart Rate (HR) ChangeMaximum HR between 5-10min HUT MINUS the baseline (pre-tilt) HRThe primary outcome measure will be the magnitude of HR change from supine to HUT (max HR between 5-10 min of HUT) for each study arm.

Secondary

MeasureTime frameDescription
Differences in Vanderbilt Orthostatic Symptom Score (VOSS) Symptom RatingAfter t=10 of the 10min HUT (or sooner if HUT has to be terminated early due to symptoms)Subjective symptom scoring as reported by participant during each study arm. The VOSS evaluates 9 symptoms on a 0 to 10 scale with 0 being no symptom to 10 being worst ever symptom. The total score ranges from 0-90, with a higher score being more severe symptoms. The 9 symptoms are mental clouding, blurred vision, shortness of breath, rapid heartbeat, tremulousness, chest discomfort, headache, lightheadedness, and nausea. The participant's VOSS score will be compared across the 4 arms of this study. The VOSS score has been previously used in multiple publications
Change in Systolic Blood Pressure (SBP)During the baseline before the HUT and the SBP correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.Change in continuous systolic blood pressure between supine and HUT during each study arm.
Changes in Stroke VolumeDuring the baseline before the HUT and the SV correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.Change in Stroke Volume from supine to HUT in each of the study arms.
Maximum Upright Heart RateDuring minutes 5-10 of the HUTThe maximum heart rate during minutes 5-10 of each HUT. The maximum heart rate during each of the study arms will be compared.
Change in Systemic Vascular Resistance (SVR)During the baseline before the HUT and the SVRcorrelating with the maximum HR during 5-10 min HUT, recorded at 1min intervals.Change in Systemic Vascular Resistance from supine to HUT in each of the study arms.
Change in Cerebral Blood Flow Velocity (CBFV)During the baseline before the HUT and the CBFV correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.Change in cerebral blood flow from supine to HUT in each of the study arms.
Change in Cardiac Output (CO)During the baseline before the HUT and the CO correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.Change in Cardiac Output from supine to HUT in each of the study arms.

Countries

Canada

Participant flow

Pre-assignment details

This was a randomized cross-over trial. Participants were assigned to receive the 4 compressions interventions in a randomized order. There were a total of 24 potential sequence orders of the compression interventions.

Participants by arm

ArmCount
Full Compression
The LifeWrap compression garment will be fully secured with all straps. LifeWrap Compression Garment: Non-Pneumatic Anti-Shock (NASG) compression garment comprised of neoprene with velcro closures.
30
Total30

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyData excluded from analysis1
Overall StudyEquipment Malfunction1

Baseline characteristics

CharacteristicFull Compression
Age, Continuous32 years
STANDARD_DEVIATION 11
Body Mass Index (BMI)24 kg/m^2
STANDARD_DEVIATION 6
Race and Ethnicity Not Collected— Participants
Region of Enrollment
Canada
30 Participants
Sex: Female, Male
Female
28 Participants
Sex: Female, Male
Male
2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 320 / 320 / 320 / 32
other
Total, other adverse events
0 / 320 / 320 / 320 / 32
serious
Total, serious adverse events
0 / 320 / 320 / 320 / 32

Outcome results

Primary

Orthostatic Heart Rate (HR) Change

The primary outcome measure will be the magnitude of HR change from supine to HUT (max HR between 5-10 min of HUT) for each study arm.

Time frame: Maximum HR between 5-10min HUT MINUS the baseline (pre-tilt) HR

Population: This was a crossover trial. A total of 30 participants were analyzed.

ArmMeasureValue (MEAN)Dispersion
Full CompressionOrthostatic Heart Rate (HR) Change23 beats per minuteStandard Deviation 11
Abdominal and Pelvic CompressionOrthostatic Heart Rate (HR) Change28 beats per minuteStandard Deviation 11
Lower Limb CompressionOrthostatic Heart Rate (HR) Change34 beats per minuteStandard Deviation 14
No CompressionOrthostatic Heart Rate (HR) Change39 beats per minuteStandard Deviation 18
Comparison: Repeated Measured ANOVA was used to compare the 4 compression garment configurations.p-value: <0.001ANOVA
Secondary

Change in Cardiac Output (CO)

Change in Cardiac Output from supine to HUT in each of the study arms.

Time frame: During the baseline before the HUT and the CO correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.

Population: This was a crossover trial. A total of 29 participants were analyzed.

ArmMeasureValue (MEAN)Dispersion
Full CompressionChange in Cardiac Output (CO)0.1 L/minStandard Deviation 0.7
Abdominal and Pelvic CompressionChange in Cardiac Output (CO)0.3 L/minStandard Deviation 0.7
Lower Limb CompressionChange in Cardiac Output (CO)-0.2 L/minStandard Deviation 1
No CompressionChange in Cardiac Output (CO)-0.2 L/minStandard Deviation 0.8
p-value: 0.001Repeated Measures ANOVA
Secondary

Change in Cerebral Blood Flow Velocity (CBFV)

Change in cerebral blood flow from supine to HUT in each of the study arms.

Time frame: During the baseline before the HUT and the CBFV correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.

Secondary

Change in Systemic Vascular Resistance (SVR)

Change in Systemic Vascular Resistance from supine to HUT in each of the study arms.

Time frame: During the baseline before the HUT and the SVRcorrelating with the maximum HR during 5-10 min HUT, recorded at 1min intervals.

Population: This was a crossover trial. A total of 29 participants were analyzed.

ArmMeasureValue (MEAN)Dispersion
Full CompressionChange in Systemic Vascular Resistance (SVR)-31 dyne*s/cm^5Standard Deviation 132
Abdominal and Pelvic CompressionChange in Systemic Vascular Resistance (SVR)-63 dyne*s/cm^5Standard Deviation 152
Lower Limb CompressionChange in Systemic Vascular Resistance (SVR)-22 dyne*s/cm^5Standard Deviation 157
No CompressionChange in Systemic Vascular Resistance (SVR)4.7 dyne*s/cm^5Standard Deviation 145
p-value: 0.04Repeated Measures ANOVA
Secondary

Change in Systolic Blood Pressure (SBP)

Change in continuous systolic blood pressure between supine and HUT during each study arm.

Time frame: During the baseline before the HUT and the SBP correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.

Population: This was a crossover trial. A total of 29 participants were analyzed.

ArmMeasureValue (MEAN)Dispersion
Full CompressionChange in Systolic Blood Pressure (SBP)-5 mmHgStandard Deviation 7
Abdominal and Pelvic CompressionChange in Systolic Blood Pressure (SBP)-7 mmHgStandard Deviation 8
Lower Limb CompressionChange in Systolic Blood Pressure (SBP)-10 mmHgStandard Deviation 10
No CompressionChange in Systolic Blood Pressure (SBP)-10 mmHgStandard Deviation 10
p-value: 0.01Repeated Measures ANOVA
Secondary

Changes in Stroke Volume

Change in Stroke Volume from supine to HUT in each of the study arms.

Time frame: During the baseline before the HUT and the SV correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.

Population: This was a crossover trial. A total of 29 participants were analyzed.

ArmMeasureValue (MEAN)Dispersion
Full CompressionChanges in Stroke Volume-22 mLStandard Deviation 12
Abdominal and Pelvic CompressionChanges in Stroke Volume-22 mLStandard Deviation 12
Lower Limb CompressionChanges in Stroke Volume-33 mLStandard Deviation 14
No CompressionChanges in Stroke Volume-34 mLStandard Deviation 11
p-value: <0.001Repeated Measures ANOVA
Secondary

Differences in Vanderbilt Orthostatic Symptom Score (VOSS) Symptom Rating

Subjective symptom scoring as reported by participant during each study arm. The VOSS evaluates 9 symptoms on a 0 to 10 scale with 0 being no symptom to 10 being worst ever symptom. The total score ranges from 0-90, with a higher score being more severe symptoms. The 9 symptoms are mental clouding, blurred vision, shortness of breath, rapid heartbeat, tremulousness, chest discomfort, headache, lightheadedness, and nausea. The participant's VOSS score will be compared across the 4 arms of this study. The VOSS score has been previously used in multiple publications

Time frame: After t=10 of the 10min HUT (or sooner if HUT has to be terminated early due to symptoms)

Population: This was a crossover trial. A total of 30 participants were analyzed.

ArmMeasureValue (MEAN)Dispersion
Full CompressionDifferences in Vanderbilt Orthostatic Symptom Score (VOSS) Symptom Rating12 units on a scaleStandard Deviation 10
Abdominal and Pelvic CompressionDifferences in Vanderbilt Orthostatic Symptom Score (VOSS) Symptom Rating15 units on a scaleStandard Deviation 12
Lower Limb CompressionDifferences in Vanderbilt Orthostatic Symptom Score (VOSS) Symptom Rating22 units on a scaleStandard Deviation 17
No CompressionDifferences in Vanderbilt Orthostatic Symptom Score (VOSS) Symptom Rating26 units on a scaleStandard Deviation 17
p-value: <0.001Repeated Measures ANOVA
Secondary

Maximum Upright Heart Rate

The maximum heart rate during minutes 5-10 of each HUT. The maximum heart rate during each of the study arms will be compared.

Time frame: During minutes 5-10 of the HUT

Population: This was a crossover trial. A total of 30 participants were analyzed.

ArmMeasureValue (MEAN)Dispersion
Full CompressionMaximum Upright Heart Rate92 beats per minute (bpm)Standard Deviation 14
Abdominal and Pelvic CompressionMaximum Upright Heart Rate97 beats per minute (bpm)Standard Deviation 15
Lower Limb CompressionMaximum Upright Heart Rate103 beats per minute (bpm)Standard Deviation 16
No CompressionMaximum Upright Heart Rate109 beats per minute (bpm)Standard Deviation 19
p-value: <0.001Repeated Measures ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026