Aging, Frail Elderly Syndrome, Physical Activity
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTHMB dietary supplementation
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
Intervention groups including exercise (Ex-HMB and Ex-Plac) will complete an individualized multicomponent training program, five days a week during 24 weeks.
Sponsors
Universidad de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical functional performance based on the Short Physical Performance Battery (SPPB) score | Baseline to 25 Weeks | Summary scores range from 0-12 and higher scores denote higher physical performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in lower-body strength (kg) | Baseline to 25 Weeks | Seated leg press one-repetition maximun test |
| Change in upper-body strength (kg) | Baseline to 25 Weeks | Vertical bench press one-repetition maximun test |
| Change in lower-body strength power output (m/s) | Baseline to 25 Weeks | Seated leg press load-velocity profile |
| Change in upper-body strength power output (m/s) | Baseline to 25 Weeks | Vertical bench press load-velocity profile |
| Change in frailty (score) | Baseline to 25 Weeks | Frailty phenotype determination using Fried's criteria |
| Change in lean body mass (kg) | Baseline to Week 25 | Change in lean body mass using dual energy x-ray absorptiometry |
| Change in lipid profile | Baseline to Week 25 | Plasma total, high-density lipoprotein and low-density lipoprotein cholesterol and triglycerides (all in mg/dL) |
| Change in Handgrip strength (kg) | Baseline to 25 Weeks | Using a dynamometer |
| Change in Thyroid-Stimulating Hormone (mIU/L) | Baseline to Week 25 | — |
| Change in Disability (Lawton index scores) | Baseline to 25 Weeks | Disability in instrumental activities of daily living. |
| Change in Disability (Barthel index scores) | Baseline to 25 Weeks | Disability in basic activities of daily living |
| Change in Comorbidity (score) | Baseline to 25 Weeks | When a participant presents two or more geriatric syndromes from a list of selected geriatric syndromes |
| Change in cognitive function (score) | Baseline to 25 Weeks | Using the Mini-Mental State Examination |
| Change in depression (score) | Baseline to 25 Weeks | Using the 15-item Yesavage geriatric depression |
| Change in glycaemic profile | Baseline to Week 25 | Plasma glucose, insulin and glycosylated haemoglobin (all in mg/dL) |
Countries
Spain
Outcome results
None listed