Venous InsufficiencyNCT04469361
The Effect of Training on Hemodynamic Factors in Ballet Dancer
An observational study of Venous Insufficiency and Foot Drop (Acquired), run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 14 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Venous Insufficiency, Foot Drop (Acquired)
- What is being tested?
- Navicular drop measurement, Measurement of venous return parameters in supine and Measurement of venous return parameters in standing
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Sep 2017to 5 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Ballerinas taking ballet training at least for 4 years and female sedentary students
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ballet Training on Plantar Venous Pump Activity in Ballerinas
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
- Conditions
- Venous Insufficiency, Foot Drop (Acquired)
- Being tested
- Navicular drop measurement, Measurement of venous return parameters in supine, Measurement of venous return parameters in standing, measurement of midfoot pressure distrubition
- Medical subject headings
- Venous Insufficiency, Peroneal Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navicular drop measurementOther
The difference in navicular height between sitting and standing positions was recorded (mm) as the amount of navicular drop.
Measurement of venous return parameters in supineOther
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
Measurement of venous return parameters in standingOther
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.
measurement of midfoot pressure distrubitionOther
In standing, midfoot pressure distrubution was measured when participants shift all of their weight to the right leg
| Study group | Role | What they receive |
|---|---|---|
| Ballerinas | Balerina students who have trained at least for 4 years Receives: Other: Navicular drop measurement; Other: Measurement of venous return parameters in supine; Other: Measurement of venous return parameters in standing; Other: measurement of midfoot pressure distrubition | |
| Female students | Female students with sedentary lifestyle Receives: Other: Navicular drop measurement; Other: Measurement of venous return parameters in supine; Other: Measurement of venous return parameters in standing; Other: measurement of midfoot pressure distrubition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of navicular drop
Navicular drop was measured in mm
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline midfoot pressure during intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start4 Sep 2017
- Primary completion3 Nov 2017
- Study completion5 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Venous InsufficiencyStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nilüfer Kablan, PhD, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469361
- Sponsor's protocol ID
- 09.2017.129
- Status last verified
- Feb 2017
- First submitted
- 2 Jul 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27025449Allen 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.
PubMed 22814244Gardner 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.
PubMed 6616290Kim 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.
PubMed 25832598Pearson 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.
PubMed 22687718Khan 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.
PubMed 7618011
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ballet Training on Plantar Venous Pump Activity in Ballerinas
- ClinicalTrials.gov ID
- NCT04469361
- Acronym / sponsor ID
- 09.2017.129
- Conditions
- Venous Insufficiency, Foot Drop (Acquired)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 3 Nov 2017 (actual)
- Study completion
- 5 Jan 2018 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ballerinas | – | Other: Navicular drop measurement, Other: Measurement of venous return parameters in supine, Other: Measurement of venous return parameters in standing, Other: measurement of midfoot pressure distrubitionBalerina students who have trained at least for 4 years |
| Female students | – | Other: Navicular drop measurement, Other: Measurement of venous return parameters in supine, Other: Measurement of venous return parameters in standing, Other: measurement of midfoot pressure distrubitionFemale students with sedentary lifestyle |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Ballerinas taking ballet training at least for 4 years and female sedentary students
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navicular drop measurementThe difference in navicular height between sitting and standing positions was recorded (mm) as the amount of navicular drop. | Other | Ballerinas, Female students |
| Measurement of venous return parameters in supineVenous 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 | Other | Ballerinas, Female students |
| Measurement of venous return parameters in standingIn 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. | Other | Ballerinas, Female students |
| measurement of midfoot pressure distrubitionIn standing, midfoot pressure distrubution was measured when participants shift all of their weight to the right leg | Other | Ballerinas, Female students |
Primary outcome
Evaluation of navicular drop
Time frame: Cchange from baseline navicular height in pre-intervention and immediately after the intervention/
Navicular drop was measured in mm
Evaluation of diameter of tibialis posterior vein in supine
Time frame: Change from baseline diameter of tibialis posterior vein during intervention
Diameter of tibialis posterior vein was measured in mm
Evaluation of flow velocity of tibialis posterior vein in supine
Time frame: Change from baseline flow velocity of tibialis posterior vein during intervention
Flow velocity of tibialis posterior vein was measured in cm/s
Evaluation of volume flow of tibialis posterior vein in supine
Time frame: Change from baseline volume flow of tibialis posterior vein during intervention
Volume flow of tibialis posterior vein was measured in ml/min
Evaluation of diameter of tibialis posterior vein during weight bearing
Time frame: Change from baseline diameter of tibialis posterior during intervention
Diameter of tibialis posterior vein was measured in mm
Evaluation of flow velocity of tibialis posterior vein during weight bearing
Time frame: Change from baseline flow velocity of tibialis posterior vein during intervention
Flow velocity of tibialis posterior vein was measured in cm/s
Evaluation of volume flow of tibialis posterior vein during weight bearing
Time frame: Change from baseline volume flow of tibialis posterior vein during intervention
Volume flow of tibialis posterior vein was measured in ml/min
Evaluation of midfoot plantar pressure during weight bearing
Time frame: Change from baseline midfoot pressure during intervention
Midfoot plantar pressure was measured in gr/cm2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Results publication: PubMed 27025449Guss-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.
- Results publication: PubMed 22814244Allen 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.
- Results publication: PubMed 6616290Gardner 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.
- Results publication: PubMed 25832598Kim 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.
- Results publication: PubMed 22687718Pearson 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.
- Results publication: PubMed 7618011Khan 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilüfer Kablan, PhD principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Insufficiency and Foot Drop (Acquired), run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of navicular drop (time frame: Cchange from baseline navicular height in pre-intervention and immediately after the intervention/). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04469361, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.