Abdominal and Lower Extremity Compression During Tilt Table Testing in Adolescent POTS Patients
Primary Purpose
Postural Orthostatic Tachycardia Syndrome (POTS), Syncope
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zoex compression garment
Sponsored by
About this trial
This is an interventional treatment trial for Postural Orthostatic Tachycardia Syndrome (POTS) focused on measuring POTS, Orthostatic, Adolescent
Eligibility Criteria
Inclusion Criteria:
- Age 12-19 years
- POTS diagnosis
- English speaking -
Exclusion Criteria:
- 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 -
Sites / Locations
- Nationwide Children's Hospital, neurology outpatient clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Abdominal and LE compression
abdominal compression only
Lower extremity compression only
Arm Description
Zoex compression garment during tilt testing (all straps)
Zoex compression garment use during tilt table testing (straps 4 and 5 fastened around thighs and abdomen)
Zoex compression garment use during tilt table testing (straps 1-4, lower extremity and thighs, fastened)
Outcomes
Primary Outcome Measures
Heart-rate elevation
Secondary Outcome Measures
Symptom onset
Full Information
NCT ID
NCT01795469
First Posted
February 18, 2013
Last Updated
January 28, 2017
Sponsor
Nationwide Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01795469
Brief Title
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
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural Orthostatic Tachycardia Syndrome (POTS), Syncope
Keywords
POTS, Orthostatic, Adolescent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abdominal and LE compression
Arm Type
Experimental
Arm Description
Zoex compression garment during tilt testing (all straps)
Arm Title
abdominal compression only
Arm Type
Experimental
Arm Description
Zoex compression garment use during tilt table testing (straps 4 and 5 fastened around thighs and abdomen)
Arm Title
Lower extremity compression only
Arm Type
Experimental
Arm Description
Zoex compression garment use during tilt table testing (straps 1-4, lower extremity and thighs, fastened)
Intervention Type
Device
Intervention Name(s)
Zoex compression garment
Intervention Description
5-strap compression of abdomen, thighs and legs
Primary Outcome Measure Information:
Title
Heart-rate elevation
Time Frame
Comparison between tilt table trials of up to 10 minutes duration without and with abdominal and/or lower extremity compression
Secondary Outcome Measure Information:
Title
Symptom onset
Time Frame
Comparison between tilt table trials of up to 10 minutes duration witout and with abdominal and/or lower extremity compression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 12-19 years
POTS diagnosis
English speaking -
Exclusion Criteria:
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 -
Facility Information:
Facility Name
Nationwide Children's Hospital, neurology outpatient clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24840763
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.
Results Reference
result
Learn more about this trial
Abdominal and Lower Extremity Compression During Tilt Table Testing in Adolescent POTS Patients
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