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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

01 Sep 2017

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.

Click here to view the full article which appeared in BMJ Open