Body CompositionNCT03510247
Physiological Changes Throughout the Competitive Rugby Season.
An observational study of Body Composition, run by University of Surrey.
Trial summary
Rugby union is a high intensity, intermittent team sport which is played over 80 minutes. Players are divided into two main positional groups, forwards and backs, with backs covering a larger distance and completing more sprints and forwards partaking in more static exertions. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Body Composition
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- May 2018to May 2020
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Male elite rugby union players.
Who may be able to join
- Male
- 18-35 years old
- Contracted player of Harlequins Rugby Club
Who cannot join
- Any participant who has been exposed to radiation exceeding 5millisieverts within the past 12 months will be excluded from dual-energy X-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) scans for the relevant time points, however all other (non-ionizing) measures will be collected.
About this study
Official title: What Physiological Changes Occur During the Competitive Rugby Union Season?
Rugby union is a high intensity, intermittent team sport which is played over 80 minutes. Players are divided into two main positional groups, forwards and backs, with backs covering a larger distance and completing more sprints and forwards partaking in more static exertions. With the game of rugby union getting progressively faster, body composition and power to weight ratio are key determinants. Due to the demands placed on these players it is essential that they are in optimal health continually, however, whilst the required physical attributes are well documented, this research will provide an insight into physiological and anthropometric changes that occur across two seasons.
During this study subjects will be asked to attend the lab on 8 occasions over the course of two seasons (June 2018, September 2018, January 2019, April 2019, June 2019, September 2019, January 2020 and April 2020). During these visits the following tests will be completed; a peripheral Quantitative Computed Tomography (pQCT) scan of the bone mineral composition of the tibia and radius, total body composition via Dual Energy X-ray Absorptiometry (DXA), anterior-posterior spine bone mineral density to assess fracture risk via DXA, vertebral fracture risk via DXA. ~24ml of whole blood will be taken to determine serum 25(OH)D, albumin, calcium, zinc, total red blood cell count, lymphocytes, monocytes, carboxy-terminal collagen crosslinks (CTX) and amino-terminal propeptide (P1NP) concentrations. In June all players will complete a 6 minute run to determine fitness. Players will be expected to measure body weight and complete wellness questionnaires daily at the club and have skinfold measurements taken monthly. global positioning system (GPS) data will be collected during each training session and performance analysis will be utilised to determine the amount of contacts completed. Illness and injury occurrences will be recorded throughout the season.
- Conditions
- Body Composition
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat percentage
Body fat percentage (%) change over the course of two seasons.
Measured: Two years
Muscle Mass
Total muscle mass (kg) change over the course of two seasons
Measured: Two years.
Secondary outcomes (2)
Fracture Risk
Bone mineral density, vertebral fracture assessment and bone structure will be combined to determine fracture risk over the course of two seasons.
Measured: Two Years
Vitamin D Status
Vitamin D status (25(OH)D) will be measured over two seasons to determine seasonal changes.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study startMay 2018 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body CompositionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victoria Benford, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510247
- Sponsor's protocol ID
- UoS-Quins1
- Status last verified
- Apr 2018
- First submitted
- 17 Apr 2018
- Last updated
- 27 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Physiological Changes Occur During the Competitive Rugby Union Season?
- ClinicalTrials.gov ID
- NCT03510247
- Acronym / sponsor ID
- UoS-Quins1
- Conditions
- Body Composition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 27 Apr 2018 (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.
Rugby union is a high intensity, intermittent team sport which is played over 80 minutes. Players are divided into two main positional groups, forwards and backs, with backs covering a larger distance and completing more sprints and forwards partaking in more static exertions. With the game of rugby union getting progressively faster, body composition and power to weight ratio are key determinants. Due to the demands placed on these players it is essential that they are in optimal health continually, however, whilst the required physical attributes are well documented, this research will provide an insight into physiological and anthropometric changes that occur across two seasons.
During this study subjects will be asked to attend the lab on 8 occasions over the course of two seasons (June 2018, September 2018, January 2019, April 2019, June 2019, September 2019, January 2020 and April 2020). During these visits the following tests will be completed; a peripheral Quantitative Computed Tomography (pQCT) scan of the bone mineral composition of the tibia and radius, total body composition via Dual Energy X-ray Absorptiometry (DXA), anterior-posterior spine bone mineral density to assess fracture risk via DXA, vertebral fracture risk via DXA. ~24ml of whole blood will be taken to determine serum 25(OH)D, albumin, calcium, zinc, total red blood cell count, lymphocytes, monocytes, carboxy-terminal collagen crosslinks (CTX) and amino-terminal propeptide (P1NP) concentrations. In June all players will complete a 6 minute run to determine fitness. Players will be expected to measure body weight and complete wellness questionnaires daily at the club and have skinfold measurements taken monthly. global positioning system (GPS) data will be collected during each training session and performance analysis will be utilised to determine the amount of contacts completed. Illness and injury occurrences will be recorded throughout the season.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male elite rugby union players.
Key inclusion criteria (3 listed)
- Male
- 18-35 years old
- Contracted player of Harlequins Rugby Club
Key exclusion criteria (1 listed)
- Any participant who has been exposed to radiation exceeding 5millisieverts within the past 12 months will be excluded from dual-energy X-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) scans for the relevant time points, however all other (non-ionizing) measures will be collected.
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
Fat percentage
Time frame: Two years
Body fat percentage (%) change over the course of two seasons.
Muscle Mass
Time frame: Two years.
Total muscle mass (kg) change over the course of two seasons
2 secondary outcomes
Fracture Risk
Time frame: Two Years
Vitamin D Status
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Composition, run by University of Surrey.
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 3 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 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Fat percentage (time frame: Two years). The study lists 2 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 27 Apr 2018.