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A protocol for a randomised controlled trial of the bone response to impact loading or resistance training in young women with lower than average bone mass: the OPTIMA-Ex trial
  1. Conor Lambert1,2,
  2. Belinda R Beck1,2,3,
  3. Amy T Harding1,2,
  4. Steven L Watson1,2,
  5. Benjamin K Weeks1,2
  1. 1 Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia
  2. 2 School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia
  3. 3 The Bone Clinic, Brisbane, Queensland, Australia
  1. Correspondence to Benjamin K Weeks; b.weeks{at}griffith.edu.au

Abstract

Introduction The aim of the Osteoporosis Prevention Through Impact and Muscle-loading Approaches to Exercise trial is to compare the bone response to two known osteogenic stimuli — impact loading exercise and resistance training. Specifically, we will examine the effect of a 10-month, twice-weekly, high-intensity impact loading exercise intervention and a 10-month, twice-weekly, high-intensity resistance training intervention on bone mass and strength at clinically important skeletal sites. The intervention groups will be compared against a home-based ‘positive’ control group. Safety and acceptability of each exercise modality will also be determined.

Methods and analysis Sedentary otherwise healthy young women aged 18–30 years with bone mineral density (BMD) T-scores less than or equal to 0 at the hip and lumbar spine, screened for conditions and medications that influence bone and physical function, will be recruited. Eligible participants are randomised to 10-month, twice-weekly, either supervised high-intensity impact training, high-intensity resistance training or a home-based ‘positive’ control group. The primary outcome measure will be lumbar spine areal BMD, while secondary outcome measures will include: whole body, femoral neck and regional measures (upper and lower limb) of bone, muscle and fat; anthropometrics; muscle strength and power; quality of life and exercise safety, enjoyment and acceptability. All outcome measures will be conducted at baseline (T0) and 10 months (T10) and will be analysed according to the intention-to-treat principle and per protocol.

Ethics and dissemination The study has been granted ethical approval from the Griffith University Human Research Ethics Committee (GU Ref: 2015/775). Standard scientific reporting practices will occur, including publication in peer-reviewed journals. Participant confidentiality will be maintained in all forms of reporting.

Trial registration number ACTRN12616001444471.

  • bone mass
  • boxing
  • impact exercise
  • jumping
  • resistance training
  • young women

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors Conception and design of the study: CL, BRB, SLW, BKW. Manuscript preparation and editing the final paper for submission: CL, ATH, BRB, BKW. Preparation of information sheets, consent forms and case report forms: CL, BRB, SLW, BKW. Participant recruitment data collection and participant training: CL. Principle investigator: BKW.

  • Funding This research is an unfunded PhD project which received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. The PhD candidate is supported by the Australian Government Research Training Program Scholarship and Griffith University Higher Degree Research student funds.

  • Competing interests None declared.

  • Ethics approval The trial has received ethical approval from the Griffith University Human Research Ethics Committee (GU Ref: 2015/775), and has been prospectively registered with the Australian New Zealand Clinical Trials Registry (#ACTRN12616001444471).

  • Provenance and peer review Not commissioned; externally peer reviewed.