A High-PRotein Mediterranean Diet and Resistance Exercise for Cardiac Rehabilitation: a Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Follow up rates
研究概览
简要总结
Cardiovascular disease is responsible for a quarter of all deaths in the UK and risk seems to be higher in cardiac rehabilitation (CR) with lower body weight which may be due to sarcopenci obesity (SO) or low muscle mass with high fat mass. The investigators aim to investigate the effect of a high protein Mediterranean diet and resistance exercise on improving lean mass and reducing risk markers of cardiovascular disease
详细描述
BACKGROUND Cardiovascular disease (CVD) in the UK is behind 1 in 4 deaths/year (>150,000 people), with coronary heart disease (CHD) being the most common type [1]. In addition to the loss of life, the economic cost of CVD is considerable; in 2015 healthcare for CVD alone in the UK amounted to £10.9 billion with a further £7.7 billion lost from the economy due to productivity loses [2].
Mortality figures due to CHD have been reduced recently, in part due to increased provision of cardiac rehabilitation (CR), a therapeutic approach based on exercise training to improve cardiac function, plus advice regarding smoking cessation, dietary changes and weight loss [3].
RATIONALE Most of the evidence on the benefit of CR examines the links between exercise and CV morbidity and mortality [4]; however, there is considerable evidence showing improvements in markers of cardiovascular risk through different dietary strategies [5]. Of particular relevance, results from studies on both the primary and secondary prevention of CVD suggest Mediterranean diet-based approaches are the most adequate to treat these patients [6-13].
Obesity, and in particular, visceral adiposity, is associated with cardiometabolic (CM) risk markers (e.g., high cholesterol and triglycerides levels, HbA1c, etc.) [14-16], however, an "obesity paradox" appears to exist in the cardiac population, where increased mortality has been linked to low body mass index (BMI) [17, 18]. However, low lean body mass (LBM) is the likely driver of this phenomenon due to sarcopenia, a progressive loss of LBM associated with aging [19]. Patients with a combination of low LBM and abdominal distribution of body fat, known as sarcopenic obesity (SO), are at greater risk of CVD, exacerbated in CR [20-23]. Thus, increasing relative LBM content, rather than simply promoting weight loss, may be an appropriate target in CR patients.
One particular barrier to maintaining or accruing LBM is the presence of anabolic resistance in older adults, which can result in a reduced muscle protein synthetic (MPS) response to both exercise and the ingestion of currently recommended intakes of protein [24]. Protein intakes above currently recommended levels (1.0-1.5 g/kg/BW) [25] combined with sufficiently intense resistance training [26] can overcome this anabolic resistance and positively influence muscle mass, ultimately leading to greater improvement in body composition, when accompanied by a reduction in total body fat mass [27].
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent given
- •Ability to attend screening at Liverpool John Moores University
- •Cardiac function deemed stable after phase 3 cardiac rehabilitation
排除标准
- •Inability to perform resistance exercise (determined by primary care team)
- •Renal dysfunction
- •Inability/unwillingness to digest/consume dairy products
- •Admission to CR due to congenital or drug/alcohol-abuse induced cardiac events
- •Pregnancy
研究组 & 干预措施
High-Protein mediterranean Diet and Resistance Exercise
Participants will be asked to perform resistance exercise. This involves weights or weight machines aimed at building muscle strength. Participants will be required to attend 3 sessions per week and each session is expected to last approximately 45 minutes.
Personalised dietary advice: we will ask participants to make changes to their diet to adapt it to a high-protein, Mediterranean-style diet
- eating more fruit and vegetables,
- reducing commercial pastries, and replacing refined carbohydrate foods (white bread, white rice, white pasta) by wholegrains (wholegrain bread, rice and pasta),
- replacing butter and margarine by olive oil as the main culinary fat,
- reducing fatty meat and replacing by lean meat, fish, and legumes (peas, beans, lentils), and by high-protein, low fat foods, such as low-fat dairy (participants will be provided with 2 dairy-based protein shakes to consume each day).
干预措施: Resistance Exercise (Other)
Standard Care
Participants will perform standard cardiac rehabilitation involving weekly (1-3 days) aerobic-focused exercise sessions in community gyms.
Participants will have received guidance on weight management and healthy eating from cardiac rehabilitation staff but will not receive any further dietary support.
干预措施: Standard Cardiac Rehabilitation Exercise (Other)
High-Protein mediterranean Diet and Resistance Exercise
Participants will be asked to perform resistance exercise. This involves weights or weight machines aimed at building muscle strength. Participants will be required to attend 3 sessions per week and each session is expected to last approximately 45 minutes.
Personalised dietary advice: we will ask participants to make changes to their diet to adapt it to a high-protein, Mediterranean-style diet
- eating more fruit and vegetables,
- reducing commercial pastries, and replacing refined carbohydrate foods (white bread, white rice, white pasta) by wholegrains (wholegrain bread, rice and pasta),
- replacing butter and margarine by olive oil as the main culinary fat,
- reducing fatty meat and replacing by lean meat, fish, and legumes (peas, beans, lentils), and by high-protein, low fat foods, such as low-fat dairy (participants will be provided with 2 dairy-based protein shakes to consume each day).
干预措施: High-Protein Mediterranean Diet (Other)
Standard Care
Participants will perform standard cardiac rehabilitation involving weekly (1-3 days) aerobic-focused exercise sessions in community gyms.
Participants will have received guidance on weight management and healthy eating from cardiac rehabilitation staff but will not receive any further dietary support.
干预措施: Standard Dietary Advice (Other)
结局指标
主要结局
Follow up rates
时间窗: 18 months
Number of participants that respond to follow up questionnaires
Acceptability of exercise intervention
时间窗: 18 months
Qualitative data from focus groups
Acceptability of dietary intervention
时间窗: 18 months
Qualitative data from focus groups
Feasability of recruitment
时间窗: 10 months
Recruitment numbers over time course of study
Adherence to exercise protocol
时间窗: 12 weeks
Number of exercise sessions actually attended out of number of prescribed sessions
次要结局
- Change in appendicular skeletal muscle mass (DXA)(12 weeks)
- Change in visceral fat mass (DXA)(12 weeks)
- Change in total cholesterol(12 weeks)
- Change in body weight(12 weeks)
- Change in Total cholesterol : HDL cholesterol ratio(12 weeks)
- Change in HbA1c(12 weeks)
- Change in waist:height ratio(12 weeks)
- Change in muscle mass (BIA)(12 weeks)
- Change in back/leg strength(12 weeks)
- Change in muscle mass (DXA)(12 weeks)
- Change in fasting triglycerides(12 weeks)
- Change in blood pressure(12 weeks)
- Change in grip strength(12 weeks)
- Change in fat mass (BIA)(12 weeks)
- Change in waist circumference(12 weeks)
- Height(12 weeks)
- Improvement in cardiometabolic risk markers(12 weeks)
- Change in fasting glucose(12 weeks)
- Change in sarcopenia Quality of life score(12 weeks)
- Change in HDL cholesterol(12 weeks)
- Change in non-HDL cholesterol(12 weeks)
- Change in mediterranean diet score(12 weeks)
研究者
Richie Kirwan
Post-graduate researcher
Liverpool John Moores University
