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Abdominal and Lower Extremity Compression During Tilt Table Testing in Adolescent POTS Patients

Abdominal and Lower Extremity Compression During Tilt Table Testing in Adolescent POTS Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01795469
Enrollment
20
Registered
2013-02-20
Start date
2013-02-28
Completion date
2016-02-29
Last updated
2017-01-31

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

Conditions

Postural Orthostatic Tachycardia Syndrome (POTS), Syncope

Keywords

POTS, Orthostatic, Adolescent

Brief summary

Postural orthostatic tachycardia syndrome (POTS) is a common cause of orthostatic intolerance in adolescents and adults. Compression stockings are commonly recommended as a treatment modality for POTS, but the effects of abdominal and lower extremity compression during tilt table testing have not been measured in adolescent patients. The aims of our study are to compare heart-rate changes and symptom onset during tilt table testing (a) with and without abdomen/lower extremity compression and (b) with abdominal compression only versus lower extremity compression only. During phase 1, 20 adolescents with POTS will undergo up to 10 minutes of tilt without compression (trial #1), a repeat study of up to 10 minutes with full compression (trial #2), and a third study without compression up to 10 minutes (trial #3). Compression will be performed using the non-inflatable Zoex anti-shock garment. During study phase 2, an additional 20 adolescent POTS patients will undergo up to 10 minutes of tilt without compression (trial #1), a repeat study of up to 10 minutes with abdominal compression only \[n=10\] or lower extremity compression only \[n=10\] (trial #2), and a third study repeated without compression up to 10 minutes (trial #3). To limit compression to the abdomen only, we will use the Zoex garment strap numbers 4 and 5 (thigh and abdomen) without straps 1-3 (lower extremities). For lower extremity-only compression, we will use Zoex garment straps 1-4 (lower extremity and thigh) without strap 5. Data collected will include mean and peak heart rates and timing of symptoms with each trial. A paired-samples t-test will be used to compare mean heart rates between trials for each study phase. Hazard analyses will be used to assess time-based endpoints.

Interventions

DEVICEZoex compression garment

5-strap compression of abdomen, thighs and legs

Sponsors

Nationwide Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 19 Years
Healthy volunteers
No

Inclusion criteria

1. Age 12-19 years 2. POTS diagnosis 3. English speaking -

Exclusion criteria

1. Somatic, cognitive, or psychiatric disorder that could prevent safe tilt table testing 2. Medications that cannot be stopped/held safely for the procedure, but can cause or exacerbate orthostatic intolerance -

Design outcomes

Primary

MeasureTime frame
Heart-rate elevationComparison between tilt table trials of up to 10 minutes duration without and with abdominal and/or lower extremity compression

Secondary

MeasureTime frame
Symptom onsetComparison between tilt table trials of up to 10 minutes duration witout and with abdominal and/or lower extremity compression

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026