NCT05212363

Brief Summary

Compression garments are used to exert external pressure on the lower extremities to reduce vascular wall tension and prevent gravity form pooling blood in the lower extremities which will improve venous return and lymphatic output. Given the nature of video game play, sitting for prolonged periods of time without an active break is the perfect scenario to put these players at risk for deep vein thromboses (DVTs). Graduated compression wear may offer significant health benefits to this rapidly expanding sport. This study is essential to the formation of effective performance wear to reduce health risks in a gaming population.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

December 9, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2022

Completed
Last Updated

December 6, 2022

Status Verified

December 1, 2022

Enrollment Period

4 months

First QC Date

September 1, 2021

Last Update Submit

December 2, 2022

Conditions

Keywords

EsportGamingVideo games

Outcome Measures

Primary Outcomes (3)

  • Popliteal artery blood flow velocity

    A B0MJ18Philips L9-3 Transducer will be used to measure popliteal artery blood velocity at rest, and every 30 minutes for 120 minutes during prolonged gaming

    2 hours

  • Popliteal artery blood Volume

    A B0MJ18Philips L9-3 Transducer will be used to measure popliteal artery blood volume at rest, and every 30 minutes for 120 minutes during prolonged gaming

    2 hours

  • Popliteal artery Transverse Diameter

    A B0MJ18Philips L9-3 Transducer will be used to measure popliteal artery transverse diameter at rest, and every 30 minutes for 120 minutes during prolonged gaming

    2 hours

Secondary Outcomes (1)

  • Compression garment and Esport performance perception survey

    2 hours

Study Arms (3)

Calf Compression

EXPERIMENTAL

Subjects will wear calf compression garments while video gaming for 2 hours. All subjects will undergo blood flow assessments before and after wearing lower leg graduated compression gear during their gaming session (i.e. compression during uninterrupted sitting).

Device: Lower extremity compression garments

6- minute Walk

EXPERIMENTAL

Subjects will game for 2 hours sitting and take a 6 minute walking break at the one hour period before resuming game play. All subjects will undergo blood flow assessments before and after taking an active break (i.e. 6-minute walk) during their gaming session.

Behavioral: Active break

Continuous video game play

NO INTERVENTION

Subjects will game for 2 hours sitting with no break. All subjects will undergo blood flow assessments without wearing lower leg graduated compression gear or taking an active break during their gaming session (i.e. during uninterrupted sitting).

Interventions

Compression garments are used to exert external pressure on the lower extremities to reduce vascular wall tension and prevent gravity form pooling blood in the lower extremities which will improve venous return and lymphatic output. Following the resting measurements, subjects will be instructed to wear the garments and moved to the seated gaming position for 2 hours.

Calf Compression
Active breakBEHAVIORAL

An active break is currently considered "gold standard" for increasing blood flow after prolonged sitting. The 6-minute walk will be conducted indoors next to the esport lab in the Wisser library at NYIT, Old Westbury. Participants will be asked to walk for 6 minutes on a flat surface back and forth following one hour of game play.

6- minute Walk

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ranked esport player with over 500 hours in their game.
  • Non-smoker.
  • No history of heart disease, pulmonary disease, or metabolic disease including diabetes.
  • Taking any prescribed or over the counter medications that would influence metabolic outcomes or blood viscosity.

You may not qualify if:

  • Peripheral neuropathy or any other condition that impacts skin sensation.
  • A history of a peripheral arterial bypass grafting.
  • Peripheral artery disease.
  • Skin infection.
  • Dermatitis with oozing or fragile skin.
  • Current leg swelling
  • Pulmonary edema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Institute of Technology College of Osteopathic Medicine

Old Westbury, New York, 11568, United States

Location

Related Publications (13)

  • Book J, Prince CN, Villar R, Hughson RL, Peterson SD. Investigating the impact of passive external lower limb compression on central and peripheral hemodynamics during exercise. Eur J Appl Physiol. 2016 Apr;116(4):717-27. doi: 10.1007/s00421-016-3331-0. Epub 2016 Jan 25.

    PMID: 26811062BACKGROUND
  • Beasley R, Raymond N, Hill S, Nowitz M, Hughes R. eThrombosis: the 21st century variant of venous thromboembolism associated with immobility. Eur Respir J. 2003 Feb;21(2):374-6. doi: 10.1183/09031936.03.00039403.

    PMID: 12608454BACKGROUND
  • Lippi G, Mattiuzzi C, Favaloro EJ. e-thrombosis: epidemiology, physiopathology and rationale for preventing computer-related thrombosis. Ann Transl Med. 2018 Sep;6(17):344. doi: 10.21037/atm.2018.09.03.

    PMID: 30306083BACKGROUND
  • Pearce L. Playing with danger. Nurs Stand. 2012 Aug 29-Sep 4;26(52):25. doi: 10.7748/ns.26.52.25.s24.

    PMID: 23061127BACKGROUND
  • Restaino RM, Holwerda SW, Credeur DP, Fadel PJ, Padilla J. Impact of prolonged sitting on lower and upper limb micro- and macrovascular dilator function. Exp Physiol. 2015 Jul 1;100(7):829-38. doi: 10.1113/EP085238. Epub 2015 Jun 10.

    PMID: 25929229BACKGROUND
  • McManus AM, Ainslie PN, Green DJ, Simair RG, Smith K, Lewis N. Impact of prolonged sitting on vascular function in young girls. Exp Physiol. 2015 Nov;100(11):1379-87. doi: 10.1113/EP085355. Epub 2015 Oct 7.

    PMID: 26370881BACKGROUND
  • Wennberg P, Boraxbekk CJ, Wheeler M, Howard B, Dempsey PC, Lambert G, Eikelis N, Larsen R, Sethi P, Occleston J, Hernestal-Boman J, Ellis KA, Owen N, Dunstan DW. Acute effects of breaking up prolonged sitting on fatigue and cognition: a pilot study. BMJ Open. 2016 Feb 26;6(2):e009630. doi: 10.1136/bmjopen-2015-009630.

    PMID: 26920441BACKGROUND
  • Carter SE, Draijer R, Holder SM, Brown L, Thijssen DHJ, Hopkins ND. Regular walking breaks prevent the decline in cerebral blood flow associated with prolonged sitting. J Appl Physiol (1985). 2018 Sep 1;125(3):790-798. doi: 10.1152/japplphysiol.00310.2018. Epub 2018 Jun 7.

    PMID: 29878870BACKGROUND
  • Chrismas BCR, Taylor L, Cherif A, Sayegh S, Bailey DP. Breaking up prolonged sitting with moderate-intensity walking improves attention and executive function in Qatari females. PLoS One. 2019 Jul 12;14(7):e0219565. doi: 10.1371/journal.pone.0219565. eCollection 2019.

    PMID: 31299061BACKGROUND
  • DiFrancisco-Donoghue J, Balentine J, Schmidt G, Zwibel H. Managing the health of the eSport athlete: an integrated health management model. BMJ Open Sport Exerc Med. 2019 Jan 10;5(1):e000467. doi: 10.1136/bmjsem-2018-000467. eCollection 2019.

    PMID: 30792883BACKGROUND
  • Berszakiewicz A, Sieron A, Krasinski Z, Cholewka A, Stanek A. Compression therapy in venous diseases: physical assumptions and clinical effects. Postepy Dermatol Alergol. 2020 Dec;37(6):842-847. doi: 10.5114/ada.2019.86990. Epub 2019 Jul 26.

    PMID: 33603600BACKGROUND
  • Pollock BS, Barkley JE, Potenzini N, Desalvo RM, Buser SL, Otterstetter R, Juvancic-Heltzel JA. Validity of Borg Ratings of Perceived Exertion During Active Video Game Play. Int J Exerc Sci. 2013 Apr 15;6(2):164-170. doi: 10.70252/XGRF9788. eCollection 2013.

    PMID: 27293499BACKGROUND
  • Restaino RM, Walsh LK, Morishima T, Vranish JR, Martinez-Lemus LA, Fadel PJ, Padilla J. Endothelial dysfunction following prolonged sitting is mediated by a reduction in shear stress. Am J Physiol Heart Circ Physiol. 2016 Mar 1;310(5):H648-53. doi: 10.1152/ajpheart.00943.2015. Epub 2016 Jan 8.

    PMID: 26747508BACKGROUND

Related Links

MeSH Terms

Conditions

Sedentary BehaviorVenous Thrombosis

Condition Hierarchy (Ancestors)

BehaviorThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Joanne Donoghue

    Director of Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Twelve healthy collegiate esport players will be recruited for this single-arm pilot study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2021

First Posted

January 28, 2022

Study Start

December 9, 2021

Primary Completion

April 2, 2022

Study Completion

April 2, 2022

Last Updated

December 6, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations