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

• Published in: BMJ open 2017-09, Vol.7 (9), p.e016983
• Main Authors: Lambert, Conor, Beck, Belinda R, Harding, Amy T, Watson, Steven L, Weeks, Benjamin K
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Bone Density; Boxing; Evidence-based medicine; Exercise; Female; Femur Neck - metabolism; Health care; Health risk assessment; Humans; Lumbar Vertebrae - metabolism; Mens health; Middle age; Movement; Muscle Strength; Osteoporosis; Osteoporosis - metabolism; Osteoporosis - prevention & control; Physical fitness; Quality of life; Research Design; Resistance Training; Sports and Exercise Medicine; Strength training; Validity; Weight-Bearing; Womens health; Young Adult; Young adults
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2017-016983

IntroductionThe 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 analysisSedentary 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 disseminationThe 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 numberACTRN12616001444471.