The CHILL BONES (combining high-intensity impact loading and lifting with mind-body exercise for optimisation of nervous system and skeletal health) trial: protocol for a parallel-group, semi-randomised controlled trial.

Abstract

Animal studies suggest that elevated sympathetic nervous system (SNS) activity can accelerate bone loss. However, this area has not been well researched in humans. High-intensity Resistance and Impact Training (HiRIT) is recognised as an effective treatment for osteoporosis and osteopenia. Alternate forms of exercise such as mind-body exercise may be used to modulate sympathetic activity, which could have an additive benefit for skeletal adaptation when used in conjunction with HiRIT. The aim of this study is to investigate whether the combination of mind-body exercise (Tai Chi) and HiRIT can be used to concurrently modulate SNS activity and improve skeletal health. The CHILL BONES trial is a semi-randomised controlled trial where consenting adults over 60 years, who have low bone mass (total hip, femoral neck and/or lumbar spine T-score <-1.0) will be randomly allocated to participate in 8 months of twice-weekly Tai Chi, HiRIT or combined (Tai Chi+HiRIT) exercise. If participants are unwilling or unable to undertake exercise, they may opt into a non-exercising control group. The primary outcome will be total hip areal bone mineral density (BMD) measured using dual-energy X-ray absorptiometry. Secondary outcomes include femoral neck BMD, lumbar spine BMD, resting and reflexive skin sympathetic nerve activity and heart rate variability. Outcomes will be measured at baseline and post-intervention (8 months). Both intention-to-treat and per-protocol analyses will be undertaken. Ethical approval was granted by the Griffith University Human Research Ethics Committee (GUHREC; GU Ref No: 2023/448). Trial findings will be disseminated to participants via a plain-language summary upon completion. Results will be formally reported through peer-reviewed journals and conference presentations. ACTRN12623001209684; Australian New Zealand Clinical Trials Registry.