HMB Supplementation in Addition to Multicomponent Exercise in Old Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of β-hydroxy-β-methylbutyrate (HMB) Supplementation in Addition to Multicomponent Exercise in Old Adults Living in Nursing Homes

Conditions
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Aging, Frail Elderly Syndrome, Physical Activity

Intervention / Treatment
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* Dietary Supplement: HMB dietary supplementation
* Other: Multicomponent physical exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ex-HMB<br>HMB dietary supplementation and Multicomponent physical exercise program | Dietary Supplement: HMB dietary supplementation<br>* Intervention groups including HMB supplementation (Ex-HMB and NoEx-HMB) will receive a 3 g daily dose of free acid HMB in powder form dissolved freely into 250 mL of water during a 24-week intervention<br>Other: Multicomponent physical exercise program<br>* Intervention groups including exercise (Ex-HMB and Ex-Plac) will complete an individualized multicomponent training program, five days a week during 24 weeks.<br>|
| Experimental: NoEx-HMB<br>HMB Dietary supplementation | Dietary Supplement: HMB dietary supplementation<br>* Intervention groups including HMB supplementation (Ex-HMB and NoEx-HMB) will receive a 3 g daily dose of free acid HMB in powder form dissolved freely into 250 mL of water during a 24-week intervention<br>|
| Placebo Comparator: Ex-Plac<br>Multicomponent physical exercise program | Other: Multicomponent physical exercise program<br>* Intervention groups including exercise (Ex-HMB and Ex-Plac) will complete an individualized multicomponent training program, five days a week during 24 weeks.<br>|
| No Intervention: Controls<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical functional performance based on the Short Physical Performance Battery (SPPB) score | Summary scores range from 0-12 and higher scores denote higher physical performance. | Baseline to 25 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Handgrip strength (kg) | Using a dynamometer | Baseline to 25 Weeks | 
| Change in lower-body strength (kg) | Seated leg press one-repetition maximun test | Baseline to 25 Weeks | 
| Change in upper-body strength (kg) | Vertical bench press one-repetition maximun test | Baseline to 25 Weeks | 
| Change in lower-body strength power output (m/s) | Seated leg press load-velocity profile | Baseline to 25 Weeks | 
| Change in upper-body strength power output (m/s) | Vertical bench press load-velocity profile | Baseline to 25 Weeks | 
| Change in frailty (score) | Frailty phenotype determination using Fried's criteria | Baseline to 25 Weeks | 
| Change in lean body mass (kg) | Change in lean body mass using dual energy x-ray absorptiometry | Baseline to Week 25 | 
| Change in lipid profile | Plasma total, high-density lipoprotein and low-density lipoprotein cholesterol and triglycerides (all in mg/dL) | Baseline to Week 25 | 
| Change in glycaemic profile | Plasma glucose, insulin and glycosylated haemoglobin (all in mg/dL) | Baseline to Week 25 | 
| Change in Thyroid-Stimulating Hormone (mIU/L) |  | Baseline to Week 25 | 
| Change in Disability (Lawton index scores) | Disability in instrumental activities of daily living. | Baseline to 25 Weeks | 
| Change in Disability (Barthel index scores) | Disability in basic activities of daily living | Baseline to 25 Weeks | 
| Change in Comorbidity (score) | When a participant presents two or more geriatric syndromes from a list of selected geriatric syndromes | Baseline to 25 Weeks | 
| Change in cognitive function (score) | Using the Mini-Mental State Examination | Baseline to 25 Weeks | 
| Change in depression (score) | Using the 15-item Yesavage geriatric depression | Baseline to 25 Weeks |