NCT03510247

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2018

Status
unknown

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

April 17, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 27, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

April 27, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

April 17, 2018

Last Update Submit

April 25, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Fat percentage

    Body fat percentage (%) change over the course of two seasons.

    Two years

  • Muscle Mass

    Total muscle mass (kg) change over the course of two seasons

    Two years.

Secondary Outcomes (2)

  • Fracture Risk

    Two Years

  • Vitamin D Status

    Two years

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male elite rugby union players.

You may qualify if:

  • Male
  • years old
  • Contracted player of Harlequins Rugby Club

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 17, 2018

First Posted

April 27, 2018

Study Start

May 1, 2018

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

April 27, 2018

Record last verified: 2018-04