跳至主要内容
临床试验/NCT02379026
NCT02379026Unknown不适用

Improving Body Composition, Strength, Function and Health Related Quality of Life in Older Individuals With Sarcopenic Obesity Through Lifestyle Modifications

Queen Margaret University2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
18
试验地点
2
主要终点
Skeletal muscle mass

研究概览

简要总结

This study evaluates the addition of a high-protein energy-restricted diet to exercise in the treatment of sarcopenic obesity in people aged 65 and over. Half of participants will follow a hypocaloric (500 kcal deficit) high-protein (1.2 -1.5 g Protein/ kg bodyweight) diet alongside an exercise regime, while the other half will follow the same exercise regime alongside their habitual diet . All participants will consume a Vitamin D3 tablet (25micrograms) 3 times a week to achieve a weekly intake of 75 micrograms. Total duration of the intervention will be 16 weeks.

详细描述

Sarcopenic Obesity is associated with advanced ageing and is characterised by increased adipose tissue and loss of muscle mass, strength and/or function. The combination of sarcopenia and obesity can predispose older individuals to more functional disabilities than either of these two conditions alone, leading eventually to increased rates of morbidity and mortality. Lifestyle interventions focusing on physical activity and diet have been suggested as an effective tackling strategy. However, there is limited evidence on the efficacy of such interventions in sarcopenic obese individuals over 65 years of age. Therefore, the aim of this study is to assess the impact of a high protein energy-restriction diet and a mixed exercise program on body composition, strength, functionality and quality of life in older people with sarcopenic obesity.

This is a prospective randomised control trial among independent living sarcopenic obese community-dwellers. Eligible participants are people over 65y who experience increased adiposity (% body fat >28% in men and >40% in women) and low skeletal muscle index (SMI <10.75 kg/m2 in men and <6.75kg/m2 in women). Fifty (50) participants will be randomly allocated to either the exercise group (EX) or the exercise plus high protein energy-restricted diet group (EXD). Each group will undergo 3 exercise sessions/ week for a period of 16 weeks. The exercise sessions will be similar for both groups and will incorporate aerobic, resistance, balance and flexibility elements. The EXD group will receive a 500kcal-deficit diet plan and a milk-based protein supplement (ProMilk 50 by Myprotein; 50 g milk protein/ 500 ml bottle) to consume every day (at post-workout on exercise days or as a pre-bed snack on non-exercising days). The protein consumption will be in the range of 1.2-1.5 g.kg bw-1. A total weekly dose of 75mcg Vitamin D3 (3 x 25mcg) will be administered orally to all participants to avoid potential confounders associated with Vitamin D deficiency/hypovitaminosis. The primary and secondary outcomes will be evaluated at baseline, week 10 and week 16.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Independent living community-dwellers
  • Sarcopenic
  • Montreal Cognitive Assessment test (MoCA) score > or = 26

排除标准

  • Use of pacemaker
  • Lactose intolerance
  • Parkinson's disease
  • Unmanaged pain
  • Severe osteoporosis or arthritis
  • Use of corticosteroids
  • History of pulmonary embolus or myocardial infarction within the previous 2 years
  • Heart disease
  • Chronic obstructive pulmonary disease
  • Chronic kidney disease
  • Hypertension (resting systolic pressure >200mmHg, resting diastolic >100mmHg)
  • Acute systemic illnesses
  • Any other uncontrolled physical, psychological or mental condition that either prohibits adherence to the study protocol or increases significantly the health risks for the subject.

结局指标

主要结局

Skeletal muscle mass

时间窗: Baseline, 10 weeks, 16 weeks

Assess changes in total skeletal muscle mass (in kilograms) using bioelectrical impedance analysis at baseline, week 10 and week 16.

Body fat mass

时间窗: Baseline, 10 weeks, 16 weeks

Assess changes in body fat mass (in kg) using bioelectrical impedance analysis at baseline, week 10 and week 16.

次要结局

  • Dynamic Balance(Baseline, 10 weeks, 16 weeks)
  • Functional Mobility(Baseline, 10 weeks, 16 weeks)
  • Health related quality of life(Baseline, 16 weeks)
  • Physical Performance(Baseline, 10 weeks, 16 weeks)
  • Central adiposity(Baseline, 10 weeks, 16 weeks)
  • Handgrip strength(Baseline, 10 weeks, 16 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christos Theodorakopoulos

Mr

Queen Margaret University

研究点 (2)

Loading locations...

相似试验

Lifestyle Modifications for the Treatment of... | 临床试验