Research Institute of Sport and Exercise Science, Liverpool John Moores University, Liverpool, UK; Institute for Health Research, Liverpool John Moores University, Liverpool, UK; Carnegie School of Sport, Leeds Beckett University, Leeds, UK.
Institute for Health Research, Liverpool John Moores University, Liverpool, UK; School of Biological and Environmental Sciences, Liverpool John Moores University, Liverpool, UK.
Clin Nutr ESPEN. 2021 Oct;45:492-498. doi: 10.1016/j.clnesp.2021.08.001. Epub 2021 Aug 15.
Cardiac rehabilitation (CR) is an essential component of long-term recovery following a cardiac event. Typical CR may not be optimal for patients presenting with sarcopenic obesity (SO) who present with reduced muscle mass and elevated adipose tissue, and may indicate greater cardiovascular disease (CVD) risk. Resistance exercise and high-protein diets are known to increase muscle mass, while Mediterranean-style diets have been shown to reduce CVD risk. A high-protein Mediterranean-style diet combined with resistance exercise intervention is yet to be trialled in cardiac rehabilitation populations.
Primary outcome: to determine the feasibility of such an intervention by investigating the perceptions, acceptance and adherence to a resistance exercise protocol and high-protein Mediterranean style diet in a UK cardiac rehabilitation population with SO. Secondary outcome: to trial this protocol ahead of a fully powered clinical study.
Eligible cardiac rehabilitation patients will be randomised to one of the following: 1) a control group (standard CR), 2) high-protein Mediterranean-style diet, 3) resistance exercise group, or 4) both high-protein Mediterranean-style diet and resistance exercise group. The pilot study will last 12 weeks. Measures of body composition (dual energy x-ray absorptiometry) grip strength, CVD risk (e.g., fasting triglycerides, glucose, cholesterol) and dietary adherence will be assessed at baseline and after 12 weeks. To compare groups, a mixed model ANOVA (time x intervention) will be performed. Patient participant involvement throughout the development of this project will be used to determine the feasibility of a future, fully powered, randomised control trial. A feasibility questionnaire will help establish the proportion of eligible participants, their willingness to be randomised, response rates, and ethical considerations. Furthermore, focus groups, food tasting and telephone interviews will be conducted to assess the acceptability of recipes and exercise protocols provided.
This pilot trial will determine whether a fully powered, multi-centred randomised control trial in CR patients with SO can be implemented. The information received from patient involvement will be invaluable for identifying possible barriers to participation and tailoring interventions to participant needs, helping to increase the likelihood of long-term compliance to health-promoting lifestyle changes.
This study is registered at clinicaltrials.gov (NCT04272073), registered on 17/02/2020, https://clinicaltrials.gov/ct2/show/NCT04272073.
28/12/20 version 3.0.
心脏康复（CR）是心脏事件后长期恢复的重要组成部分。典型的 CR 可能并不适合患有肌肉减少性肥胖（SO）的患者，这些患者的肌肉量减少，脂肪组织增加，并且可能表明心血管疾病（CVD）风险更高。抗阻力运动和高蛋白饮食已知可增加肌肉量，而地中海式饮食已被证明可降低 CVD 风险。高蛋白地中海式饮食与抗阻力运动相结合的干预措施尚未在心脏康复人群中进行试验。
主要结果：通过调查英国心脏康复人群中 SO 患者对阻力运动方案和高蛋白地中海式饮食的看法、接受程度和依从性，确定这种干预措施的可行性。次要结果：在进行全面的临床研究之前，对该方案进行试验。
符合条件的心脏康复患者将被随机分配到以下组之一：1）对照组（标准 CR），2）高蛋白地中海式饮食组，3）抗阻力运动组，或 4）高蛋白地中海式饮食和抗阻力运动组。该初步研究将持续 12 周。在基线和 12 周后，将评估身体成分（双能 X 射线吸收法）握力、CVD 风险（如空腹甘油三酯、葡萄糖、胆固醇）和饮食依从性。为了比较组间差异，将进行混合模型方差分析（时间 x 干预）。在该项目的整个开发过程中，患者的参与将用于确定未来全面、随机对照试验的可行性。可行性问卷将有助于确定合格参与者的比例、他们接受随机分组的意愿、回复率和伦理考虑。此外，将进行焦点小组、品尝食物和电话访谈，以评估提供的食谱和运动方案的可接受性。
该初步试验将确定是否可以在 SO 心脏康复患者中实施全面、多中心的随机对照试验。从患者参与中获得的信息对于确定参与的可能障碍以及根据参与者的需求调整干预措施将是非常宝贵的，这有助于提高健康促进生活方式改变的长期依从性。
该研究在 clinicaltrials.gov（NCT04272073）上注册，注册日期为 2020 年 2 月 17 日，https://clinicaltrials.gov/ct2/show/NCT04272073。
2020 年 12 月 28 日第 3.0 版。
