Harding Amy T, Weeks Benjamin K, Watson Steven L, Beck Belinda R
Menzies Health Institute Queensland, Griffith University, Gold Coast Campus, Gold Coast, Queensland, Australia.
School of Allied Health Sciences, Griffith University, Gold Coast Campus, Gold Coast, Queensland, Australia.
BMJ Open. 2017 Jun 12;7(6):e014951. doi: 10.1136/bmjopen-2016-014951.
The primary aim of the proposed study is to examine the efficacy of an 8-month supervised, high-intensity progressive resistance training and impact loading programme in comparison with a supervised machine-based isometric exercise training programme using the bioDensity system in older men with low bone mass. We will also determine the safety and acceptability of each exercise training mode. Intervention group responses will be compared with those of a self-selected, non-randomised control sample of sex-matched and age-matched men who will follow their usual lifestyle activities for 8 months.
Apparently healthy men over 50 years with low bone mass, screened for medical conditions and medications known to adversely affect bone health, will be recruited. Eligible participants will be randomly allocated to 8 months of either exercise programme with block randomisation based on presence or absence of osteoporosis medications. A twice-weekly, 30-minute, supervised exercise programme will be conducted for both groups. The primary outcome will be change in femoral neck areal bone mineral density determined by dual-energy X-ray absorptiometry (DXA). Secondary outcomes, assessed at baseline and 8 months, will include: DXA-derived whole-body, bilateral proximal femur and lumbar spine areal bone mineral density; proximal femur bone geometry and volumetric density extracted using three-dimensional hip analysis software; anthropometry; body composition; kyphosis; vertebral fracture assessment; physical function; safety (adverse events and injuries); and compliance. Intention-to-treat and per-protocol analyses will be conducted.
Whether a high-intensity, low-repetition progressive resistance training and impact loading programme or a machine-based isometric exercise programme can improve determinants of fracture risk, without causing injury, has not been examined in men. Determination of the efficacy, safety and acceptability of such programmes will facilitate formulation of future exercise guidelines for older men with low bone mass at risk of fragility fracture, a group who have previously been under-represented.
Participant confidentiality will be maintained with publication of results. The study has been granted ethical approval from the Griffith University Human Research Ethics Committee (Protocol number AHS/07/14/HREC).
Australian New Zealand Clinical Trials Registry (www.anzctr.org.au)ANZCTR12616000344493; Pre-results.
本拟议研究的主要目的是，在低骨量老年男性中，比较一项为期8个月的有监督的高强度渐进性抗阻训练和冲击负荷计划与一项使用生物密度系统的有监督的基于器械的等长运动训练计划的效果。我们还将确定每种运动训练模式的安全性和可接受性。干预组的反应将与一个自我选择的、非随机对照样本（由年龄和性别匹配的男性组成，他们将在8个月内保持其通常的生活方式活动）的反应进行比较。
将招募50岁以上、明显健康且骨量低的男性，对已知会对骨骼健康产生不利影响的医疗状况和药物进行筛查。符合条件的参与者将根据是否使用骨质疏松症药物进行整群随机分组，并被随机分配到为期8个月的任一运动计划中。两组都将进行每周两次、每次30分钟的有监督的运动计划。主要结局将是通过双能X线吸收法（DXA）测定的股骨颈面积骨密度的变化。在基线和8个月时评估的次要结局将包括：DXA得出的全身、双侧近端股骨和腰椎的面积骨密度；使用三维髋部分析软件提取的近端股骨骨几何形状和体积密度；人体测量学；身体成分；脊柱后凸；椎体骨折评估；身体功能；安全性（不良事件和损伤）；以及依从性。将进行意向性分析和符合方案分析。
高强度、低重复次数的渐进性抗阻训练和冲击负荷计划或基于器械的等长运动计划能否在不造成损伤的情况下改善骨折风险的决定因素，在男性中尚未得到研究。确定此类计划的效果、安全性和可接受性将有助于为有脆性骨折风险的低骨量老年男性制定未来的运动指南，这一群体此前在研究中代表性不足。
将在公布结果时保持参与者的保密性。本研究已获得格里菲斯大学人类研究伦理委员会的伦理批准（方案编号AHS/07/14/HREC）。
澳大利亚新西兰临床试验注册中心（www.anzctr.org.au）ANZCTR12616000344493；预结果。
