Clinical trial NCT01795469: Abdominal and Lower Extremity Compression During Tilt Table Testing in Adolescent POTS Patients
Official title: Abdominal and Lower Extremity Compression During Tilt Table Testing in Adolescent POTS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural Orthostatic Tachycardia Syndrome (POTS)
Syncope
Keywords: POTS
Orthostatic
Adolescent
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 -

Primary outcomes:
measure: Heart-rate elevation
timeFrame: Comparison between tilt table trials of up to 10 minutes duration without and with abdominal and/or lower extremity compression
Secondary outcomes:
measure: Symptom onset
timeFrame: Comparison between tilt table trials of up to 10 minutes duration witout and with abdominal and/or lower extremity compression
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital, neurology outpatient clinic
state: Ohio
Study officials:
References:
citation: Heyer GL. Abdominal and lower-extremity compression decreases symptoms of postural tachycardia syndrome in youth during tilt table testing. J Pediatr. 2014 Aug;165(2):395-7. doi: 10.1016/j.jpeds.2014.04.014. Epub 2014 May 17.