Jørgensen Martin Grønbech, Ryg Jesper, Danielsen Mathias Brix, Madeleine Pascal, Andersen Stig
Department of Geriatric and Internal Medicine, Aalborg University Hospital, Hobrovej 18, 9000, Aalborg, Denmark.
Department of Geriatric Medicine, Odense University Hospital, Odense, Denmark.
Trials. 2018 Feb 9;19(1):97. doi: 10.1186/s13063-018-2441-x.
Hypertension markedly increases the risk of cardiovascular diseases and overall mortality. Lifestyle modifications, such as increased levels of physical activity, are recommended as the first line of anti-hypertensive treatment. A recent systematic review showed that isometric handgrip (IHG) training was superior to traditional endurance and strength training in lowering resting systolic blood pressure (SBP). The average length of previous IHG training studies is approximately 7.5 weeks with the longest being 10 weeks. Therefore, presently it is unknown if it is possible to further lower blood pressure levels beyond the 10-week mark. Recently, we developed a novel method for monitoring handgrip intensity using a standard Nintendo Wii Board (Wii). The primary aim of this study is to explore the effects of a 20-week IHG home training facilitated by a Wii in hypertensive older adults (50 + years of age) on lowering SBP compared to usual care. Secondary aims are to explore if/when a leveling-off effect on SBP will occur during the 20-week intervention period in the training group and to explore adherence and potential harms related to the IHG home training.
METHODS/DESIGN: Based on previous evidence, we calculated that 50 hypertensive (SBP between 140 and 179 mmHg), older adults (50 + years of age) are needed to achieve a power of 80% or more. Participants will be randomly assigned to either an intervention >group (IHG home training + hypertension guidelines on lifestyle changes) or to a control group (hypertension guidelines on lifestyle changes). Participants in the intervention group will perform IHG home training (30% of maximum grip strength for a total of 8 min per day per hand) three times a week for 20 weeks. Resting blood pressure and maximal handgrip strength will be obtained by a blinded outcome assessor in both groups at specific time points (baseline, follow-up at 5, 10, 15, and 20 weeks) throughout the study.
This assessor-blinded, randomized controlled trial will explore the effect of a 20-week IHG home training intervention on resting blood pressure in hypertensive older adults. In addition, the trial will report adherence and potential harms related to the IHG home training.
ClinicalTrials.gov, ID: NCT03069443 . Registered on 3 March 2017.
高血压显著增加心血管疾病风险和总体死亡率。推荐生活方式改变，如增加身体活动水平，作为抗高血压治疗的一线措施。最近一项系统评价显示，等长握力（IHG）训练在降低静息收缩压（SBP）方面优于传统耐力和力量训练。既往IHG训练研究的平均时长约为7.5周，最长为10周。因此，目前尚不清楚超过10周是否有可能进一步降低血压水平。最近，我们开发了一种使用标准任天堂Wii平衡板（Wii）监测握力强度的新方法。本研究的主要目的是探讨与常规护理相比，由Wii辅助的20周IHG家庭训练对高血压老年（50岁及以上）成年人降低SBP的效果。次要目的是探讨训练组在20周干预期内SBP是否/何时会出现平稳效应，并探讨与IHG家庭训练相关的依从性和潜在危害。
方法/设计：根据既往证据，我们计算得出需要50名高血压（SBP在140至179mmHg之间）老年（50岁及以上）成年人才能达到80%或更高的检验效能。参与者将被随机分配至干预组（IHG家庭训练+关于生活方式改变的高血压指南）或对照组（关于生活方式改变的高血压指南）。干预组参与者将每周进行3次IHG家庭训练（最大握力的30%，每只手每天共8分钟），持续20周。在整个研究过程中的特定时间点（基线、第5、10、15和20周随访），由 blinded 结局评估者在两组中获取静息血压和最大握力。
这项评估者盲法、随机对照试验将探讨20周IHG家庭训练干预对高血压老年成年人静息血压的影响。此外，该试验将报告与IHG家庭训练相关的依从性和潜在危害。
ClinicalTrials.gov，标识符：NCT03069443。于2017年3月3日注册。
