NCT04469361

Brief Summary

Classic ballet dance is a demonstration of complex motor skills to be revealed in aesthetic combinations and repetitively, and it demands intensive use of the lower extremities within extreme of range of motion (ROM). Because ballet practice depends on advanced technical skills, it involves intensive physical training and causes an overload on the musculoskeletal system and foot deformities such as pes planus. Plantar venous pump (PVP) is a network of multiple venous vessels located between the muscles of the foot arch. PVP is considered the first step of venous return and discharges into the posterior tibial vein (PTV). PVP is reported to be active during gait while it is inactive in resting position. There are different views on the mechanisms enabling its activation 1-3. The general view is that during the stance phase of the gait, the flattening of the plantar arch with weight transfer causes the veins in this region to narrow and creates a force that pumps the blood up. The aim of this study is the investigation what kind of hemodynamic changes ballet training causes in the lower extremity

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 4, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2018

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
Last Updated

July 14, 2020

Status Verified

February 1, 2017

Enrollment Period

2 months

First QC Date

July 2, 2020

Last Update Submit

July 8, 2020

Conditions

Outcome Measures

Primary Outcomes (8)

  • Evaluation of navicular drop

    Navicular drop was measured in mm

    Cchange from baseline navicular height in pre-intervention and immediately after the intervention/

  • Evaluation of diameter of tibialis posterior vein in supine

    Diameter of tibialis posterior vein was measured in mm

    Change from baseline diameter of tibialis posterior vein during intervention

  • Evaluation of flow velocity of tibialis posterior vein in supine

    Flow velocity of tibialis posterior vein was measured in cm/s

    Change from baseline flow velocity of tibialis posterior vein during intervention

  • Evaluation of volume flow of tibialis posterior vein in supine

    Volume flow of tibialis posterior vein was measured in ml/min

    Change from baseline volume flow of tibialis posterior vein during intervention

  • Evaluation of diameter of tibialis posterior vein during weight bearing

    Diameter of tibialis posterior vein was measured in mm

    Change from baseline diameter of tibialis posterior during intervention

  • Evaluation of flow velocity of tibialis posterior vein during weight bearing

    Flow velocity of tibialis posterior vein was measured in cm/s

    Change from baseline flow velocity of tibialis posterior vein during intervention

  • Evaluation of volume flow of tibialis posterior vein during weight bearing

    Volume flow of tibialis posterior vein was measured in ml/min

    Change from baseline volume flow of tibialis posterior vein during intervention

  • Evaluation of midfoot plantar pressure during weight bearing

    Midfoot plantar pressure was measured in gr/cm2

    Change from baseline midfoot pressure during intervention

Study Arms (2)

Ballerinas

Balerina students who have trained at least for 4 years

Other: Navicular drop measurementOther: Measurement of venous return parameters in supineOther: Measurement of venous return parameters in standingOther: measurement of midfoot pressure distrubition

Female students

Female students with sedentary lifestyle

Other: Navicular drop measurementOther: Measurement of venous return parameters in supineOther: Measurement of venous return parameters in standingOther: measurement of midfoot pressure distrubition

Interventions

The difference in navicular height between sitting and standing positions was recorded (mm) as the amount of navicular drop.

BallerinasFemale students

Venous return parameters of posterior tibial vein was measured when participant applied force equivalent to their own body weight on plantar surface of their right leg in supine position

BallerinasFemale students

In standing, venous return parameters was measured of posterior tibial vein when participants shift all of their weight to the right leg for 3 second with their leg muscles as relaxed as possible and their knee joint in full extension.

BallerinasFemale students

In standing, midfoot pressure distrubution was measured when participants shift all of their weight to the right leg

BallerinasFemale students

Eligibility Criteria

Age14 Years - 19 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsballerinas and females students with sedentary life styles
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Ballerinas taking ballet training at least for 4 years and female sedentary students

You may qualify if:

  • receiving ballet training at least 10 h per week for at least 4 years
  • receiving formal dancing training system
  • never receiving formal dancing training
  • having sedentary lifestyle

You may not qualify if:

  • Participants with a history of foot or ankle surgery,
  • Participants with connective tissue disease,
  • Participants with rigid pes planus-cavus,
  • Participants with chronic venous insufficiency
  • Participants with acute ankle injury in recent 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (6)

  • Guss-West C, Wulf G. Attentional Focus in Classical Ballet: A Survey Of Professional Dancers. J Dance Med Sci. 2016 Mar;20(1):23-9. doi: 10.12678/1089-313X.20.1.23.

  • Allen N, Nevill A, Brooks J, Koutedakis Y, Wyon M. Ballet injuries: injury incidence and severity over 1 year. J Orthop Sports Phys Ther. 2012 Sep;42(9):781-90. doi: 10.2519/jospt.2012.3893. Epub 2012 Jul 19.

  • Gardner AM, Fox RH. The venous pump of the human foot--preliminary report. Bristol Med Chir J. 1983 Jul;98(367):109-12. No abstract available.

  • Kim TI, Forbang NI, Criqui MH, Allison MA. Association of foot and ankle characteristics with progression of venous disease. Vasc Med. 2015 Apr;20(2):105-11. doi: 10.1177/1358863X14568443.

  • Pearson SJ, Whitaker AF. Footwear in classical ballet: a study of pressure distribution and related foot injury in the adolescent dancer. J Dance Med Sci. 2012;16(2):51-6.

  • Khan K, Brown J, Way S, Vass N, Crichton K, Alexander R, Baxter A, Butler M, Wark J. Overuse injuries in classical ballet. Sports Med. 1995 May;19(5):341-57. doi: 10.2165/00007256-199519050-00004.

MeSH Terms

Conditions

Venous InsufficiencyPeroneal Neuropathies

Interventions

Supine PositionStanding Position

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Nilüfer Kablan, PhD

    Marmara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 14, 2020

Study Start

September 4, 2017

Primary Completion

November 3, 2017

Study Completion

January 5, 2018

Last Updated

July 14, 2020

Record last verified: 2017-02

Locations