Development; UnilateralAsymFemaleTPNCT03142243
Morphological Asymmetry in Elite Female Tennis Players
An observational study of Development; Unilateral, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
Humans generally develop a preferred upper and lower extremity. Due to repetitive uneven loading, this gradually results in morphological adaptations to the dominant side of the body. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Development; Unilateral
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2017to 31 Dec 2019
- 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 16 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Professional, or elite, female tennis players
Who may be able to join
- Participants will have to be professional, or elite, female tennis players.
- The players will have to participate in international tournaments in Belgium.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Vrije Universiteit Brussel
Brussels, 1050
Laurent Chapelle, MSc, +32477472756, laurent.chapelle@vub.ac.be
About this study
Official title: Morphological Asymmetry in Elite Female Tennis Players Competing in an International Tournament in Belgium: an Observational Study
Humans generally develop a preferred upper and lower extremity. Due to repetitive uneven loading, this gradually results in morphological adaptations to the dominant side of the body. The corresponding morphological asymmetry can be further accentuated by (intensively) practicing a unilateral sport such as tennis, which is very popular. Yet, research on this particular topic is scarce, especially in (elite) female players. Furthermore, existing studies only examine the degree of morphological asymmetry of the upper extremity. Therefore, the aim of this study is to explore the morphological differences between the dominant and the non-dominant extremity/side on a whole body level (trunk, upper and lower extremity) in elite female tennis players.
- Conditions
- Development; Unilateral
- Keywords
- Tennis, Asymmetry, Morphological
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics
Date of birth (in day/month/year to subsequently determine age) Gender: male or female Dominant upper extremity: right or left Dominant lower extremity: right or left Playing experience (in years) Average training hours (in hours per week)
These values will be determined cross-sectionally and reported as mean and standard deviation.
Measured: 01/07/2017 - 31/12/2018
Anthropometry
Stature (cm) Weight (kg) Body Mass Index (kg/m²) Upper extremity length (cm) Lower extremity length (cm)
These values will be determined cross-sectionally and reported as mean and standard deviation.
Measured: 01/07/2017 - 31/12/2018
Body Composition
- Whole body composition: dual energy x-ray absorptiometry. Fat mass (g) lean mass (g) Bone mass (g) Bone mineral content (g) Bone mineral density (g/cm²) Bone area (cm²)
- Muscle thickness and subcutaneous fat layer: Ultrasound. Thickness of the subcutaneous fat (in mm) and muscle thickness (in mm) of the dominant and non-dominant M. Biceps Brachialis, M. Triceps Brachialis, M. Rectus Abdominis, M. Quadriceps Femoris and Hamstrings.
- Circumferences: anthropometric tape measure. Upper and lower arm (in cm) Upper and lower leg (in cm)
These values will be determined cross-sectionally and reported as mean and standard deviation.
In addition, all these outcome measures will be determined and reported for both the dominant and non-dominant upper and lower extremity separately.
Measured: 01/07/2017 - 31/12/2018
Morphological asymmetry
Side-to-side difference (i.e. dominant versus non-dominant upper and lower extremity) will be calculated and expressed as a percentage (extremity symmetry index (%)) for the outcome measures described above (i.e. fat mass, muscle mass, bone mass, bone mineral content and bone mineral density).
Extremity symmetry index = (measure dominant extremity or side / measure non-dominant extremity of side - 1) x 100
Measured: 01/07/2017 - 31/12/2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start1 Jul 2017 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development; UnilateralStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurent Chapelle, Vrije Universiteit Brussel
- Investigators
- Eva D'Hondt, PhD, Study director, Vrije Universiteit BrusselPeter Clarys, PhD, Study director, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142243
- Sponsor's protocol ID
- Asym Female Elite TP
- Acronym
- AsymFemaleTP
- Status last verified
- May 2017
- First submitted
- 3 May 2017
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared or will not be available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological Asymmetry in Elite Female Tennis Players Competing in an International Tournament in Belgium: an Observational Study
- ClinicalTrials.gov ID
- NCT03142243
- Acronym / sponsor ID
- AsymFemaleTP / Asym Female Elite TP
- Conditions
- Development; Unilateral
- Keywords
- Tennis, Asymmetry, Morphological
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 5 May 2017 (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.
Humans generally develop a preferred upper and lower extremity. Due to repetitive uneven loading, this gradually results in morphological adaptations to the dominant side of the body. The corresponding morphological asymmetry can be further accentuated by (intensively) practicing a unilateral sport such as tennis, which is very popular. Yet, research on this particular topic is scarce, especially in (elite) female players. Furthermore, existing studies only examine the degree of morphological asymmetry of the upper extremity. Therefore, the aim of this study is to explore the morphological differences between the dominant and the non-dominant extremity/side on a whole body level (trunk, upper and lower extremity) in elite female tennis players.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Professional, or elite, female tennis players
Key inclusion criteria (2 listed)
- Participants will have to be professional, or elite, female tennis players.
- The players will have to participate in international tournaments in Belgium.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographics
Time frame: 01/07/2017 - 31/12/2018
Date of birth (in day/month/year to subsequently determine age) Gender: male or female Dominant upper extremity: right or left Dominant lower extremity: right or left Playing experience (in years) Average training hours (in hours per week) These values will be determined cross-sectionally and reported as mean and standard deviation.
Anthropometry
Time frame: 01/07/2017 - 31/12/2018
Stature (cm) Weight (kg) Body Mass Index (kg/m²) Upper extremity length (cm) Lower extremity length (cm) These values will be determined cross-sectionally and reported as mean and standard deviation.
Body Composition
Time frame: 01/07/2017 - 31/12/2018
1. Whole body composition: dual energy x-ray absorptiometry. Fat mass (g) lean mass (g) Bone mass (g) Bone mineral content (g) Bone mineral density (g/cm²) Bone area (cm²) 2. Muscle thickness and subcutaneous fat layer: Ultrasound. Thickness of the subcutaneous fat (in mm) and muscle thickness (in mm) of the dominant and non-dominant M. Biceps Brachialis, M. Triceps Brachialis, M. Rectus Abdominis, M. Quadriceps Femoris and Hamstrings. 3. Circumferences: anthropometric tape measure. Upper and lower arm (in cm) Upper and lower leg (in cm) These values will be determined cross-sectionally and reported as mean and standard deviation. In addition, all these outcome measures will be determined and reported for both the dominant and non-dominant upper and lower extremity separately.
Morphological asymmetry
Time frame: 01/07/2017 - 31/12/2018
Side-to-side difference (i.e. dominant versus non-dominant upper and lower extremity) will be calculated and expressed as a percentage (extremity symmetry index (%)) for the outcome measures described above (i.e. fat mass, muscle mass, bone mass, bone mineral content and bone mineral density). Extremity symmetry index = (measure dominant extremity or side / measure non-dominant extremity of side - 1) x 100
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared or will not be available to other researchers
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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.
Eva D'Hondt, PhD study director
Vrije Universiteit Brussel
Peter Clarys, PhD study director
Vrije Universiteit Brussel
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 Development; Unilateral, run by Vrije Universiteit Brussel at 1 site in Belgium.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 May 2017. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurent Chapelle, MSc (+32477472756, laurent.chapelle@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographics (time frame: 01/07/2017 - 31/12/2018). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2017.