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

NCT01795469 | Completed

• 1 other identifier: IRB13-00033 (NCH IRB number)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Postural Orthostatic Tachycardia Syndrome (POTS); Syncope

Keywords

POTS; Orthostatic; Adolescent

Outcome Measures

Primary Outcomes (1)

• Heart-rate elevation

  Comparison between tilt table trials of up to 10 minutes duration without and with abdominal and/or lower extremity compression

Secondary Outcomes (1)

• Symptom onset

  Comparison between tilt table trials of up to 10 minutes duration witout and with abdominal and/or lower extremity compression

Study Arms (3)

Abdominal and LE compression

EXPERIMENTAL

Zoex compression garment during tilt testing (all straps)

Device: Zoex compression garment

abdominal compression only

EXPERIMENTAL

Zoex compression garment use during tilt table testing (straps 4 and 5 fastened around thighs and abdomen)

Device: Zoex compression garment

Lower extremity compression only

EXPERIMENTAL

Zoex compression garment use during tilt table testing (straps 1-4, lower extremity and thighs, fastened)

Device: Zoex compression garment

Interventions

Zoex compression garment DEVICE

5-strap compression of abdomen, thighs and legs

Abdominal and LE compression; Lower extremity compression only; abdominal compression only

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 12-19 years
• POTS diagnosis
• English speaking -

You may not qualify if:

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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital, neurology outpatient clinic

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

• 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.

  PMID: 24840763 RESULT

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome; Syncope

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: February 20, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

US (1)