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

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.

Study Overview

• Status: Completed
• Conditions: Syncope; Postural Orthostatic Tachycardia Syndrome (POTS)
• Intervention / Treatment: Device: Zoex compression garment

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital, neurology outpatient clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 15 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abdominal and LE compression; Zoex compression garment during tilt testing (all straps)	Device: Zoex compression garment; 5-strap compression of abdomen, thighs and legs
Experimental: abdominal compression only; Zoex compression garment use during tilt table testing (straps 4 and 5 fastened around thighs and abdomen)	Device: Zoex compression garment; 5-strap compression of abdomen, thighs and legs
Experimental: Lower extremity compression only; Zoex compression garment use during tilt table testing (straps 1-4, lower extremity and thighs, fastened)	Device: Zoex compression garment; 5-strap compression of abdomen, thighs and legs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Heart-rate elevation	Comparison between tilt table trials of up to 10 minutes duration without and with abdominal and/or lower extremity compression

Secondary Outcome Measures

Outcome Measure	Time Frame
Symptom onset	Comparison between tilt table trials of up to 10 minutes duration witout and with abdominal and/or lower extremity compression

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: February 18, 2013
• First Submitted That Met QC Criteria: February 18, 2013
• First Posted (Estimate): February 20, 2013

Study Record Updates

• Last Update Posted (Estimate): January 31, 2017
• Last Update Submitted That Met QC Criteria: January 28, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Adolescent; POTS; Orthostatic
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Autonomic Nervous System Diseases; Unconsciousness; Consciousness Disorders; Primary Dysautonomias; Orthostatic Intolerance; Tachycardia; Syncope; Postural Orthostatic Tachycardia Syndrome
• Other Study ID Numbers: IRB13-00033 (NCH IRB number)