Effects of β-hydroxy-β-methylbutyrate (HMB) Supplementation in Addition to Multicomponent Exercise in Old Adults Living in Nursing Homes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Change in physical functional performance based on the Short Physical Performance Battery (SPPB) score
研究概览
简要总结
Evidence supports the fact that multicomponent exercise and β-hydroxy-β-methylbutyrate (HMB) supplementation are, separately, effective in improving old adult's health and palliate functional metabolic diseases in the elderly. However, the true effect of HMB supplementation combined with a tailored exercise program in frail old adults is still unknown. Thus, the aim of the HEAL study is to assess the effects of the combination of a daily multicomponent exercise and resistance training intervention in addition to HMB supplementation on old adults' health.
详细描述
Evidence supports the fact that multicomponent exercise and β-hydroxy-β-methylbutyrate (HMB) supplementation are, separately, effective in improving old adult's health and palliate functional metabolic diseases in the elderly. However, the true effect of HMB supplementation combined with a tailored exercise program in frail old adults is still unknown.
Thus, the aim of the HEAL study is to assess the effects of the combination of a daily multicomponent exercise and resistance training intervention in addition to HMB supplementation on old adults' health.
The findings of the HEAL study will help professionals from public health systems to identify cost-effectiveness and innovative actions to improve older people's health and quality of life, and endorse exercise practice in older adults living in nursing homes.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged ≥70 years living in a nursing home
- •Be able to follow an active physical rehabilitation program
- •Be able to read and wright
- •Voluntary participation
- •Capable and willing to provide an informed consent
排除标准
- •Acute heart attack (recent 3-6 months) or unstable angina
- •Uncontrolled atrial or ventricular arrhythmias
- •Aortic dissecting aneurysm
- •Severe aortic stenosis
- •Acute endocarditis / pericarditis
- •Uncontrolled high blood pressure (>180/100 mmHg)
- •Acute thromboembolism
- •Acute or severe heart failure
- •Acute or severe respiratory failure
- •Uncontrolled postural hypotension
- •Uncontrolled acute decompensated diabetes mellitus or low blood sugar
- •A recent fracture in the last month.
- •Coincident participation in any intervention trial
- •HMB contraindication, intolerance, or allergy
- •Community-dwelling people
- •Have regularly performed exercise (>20 minutes >3 days/week) in the last 3 months
- •Malignant diseases (exceptions: basal or squamous-cell skin carcinoma or carcinoma in situ of the uterine cervix)
- •Revascularization within 1 year
- •Severe loss of vision, hearing, or communicative ability
- •Conditions preventing cooperation
结局指标
主要结局
Change in physical functional performance based on the Short Physical Performance Battery (SPPB) score
时间窗: Baseline to 25 Weeks
Summary scores range from 0-12 and higher scores denote higher physical performance.
次要结局
- Change in upper-body strength (kg)(Baseline to 25 Weeks)
- Change in Handgrip strength (kg)(Baseline to 25 Weeks)
- Change in glycaemic profile(Baseline to Week 25)
- Change in Comorbidity (score)(Baseline to 25 Weeks)
- Change in cognitive function (score)(Baseline to 25 Weeks)
- Change in lower-body strength (kg)(Baseline to 25 Weeks)
- Change in upper-body strength power output (m/s)(Baseline to 25 Weeks)
- Change in frailty (score)(Baseline to 25 Weeks)
- Change in Disability (Lawton index scores)(Baseline to 25 Weeks)
- Change in lipid profile(Baseline to Week 25)
- Change in Thyroid-Stimulating Hormone (mIU/L)(Baseline to Week 25)
- Change in lower-body strength power output (m/s)(Baseline to 25 Weeks)
- Change in lean body mass (kg)(Baseline to Week 25)
- Change in Disability (Barthel index scores)(Baseline to 25 Weeks)
- Change in depression (score)(Baseline to 25 Weeks)
研究者
Javier Courel Ibáñez
Ph.D
Universidad de Murcia