HMB Supplementation in Addition to Multicomponent Exercise in Old Adults

Not Applicable

Completed

• Conditions: Aging; Frail Elderly Syndrome; Physical Activity
• Interventions: Other: Multicomponent physical exercise program; Dietary Supplement: HMB dietary supplementation

• Registration Number: NCT03827499
• Lead Sponsor: Universidad de Murcia

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.

Study Timeline

• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-01
• Study Start: 2019-03-30
• Primary Completion: 2023-01-30
• Study Completion: 2023-04-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ex-Plac	Multicomponent physical exercise program	Multicomponent physical exercise program
Ex-HMB	HMB dietary supplementation	HMB dietary supplementation and Multicomponent physical exercise program
Ex-HMB	Multicomponent physical exercise program	HMB dietary supplementation and Multicomponent physical exercise program
NoEx-HMB	HMB dietary supplementation	HMB Dietary supplementation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in Disability (Lawton index scores)	Baseline to 25 Weeks	Disability in instrumental activities of daily living.
Change in upper-body strength (kg)	Baseline to 25 Weeks	Vertical bench press one-repetition maximun test
Change in glycaemic profile	Baseline to Week 25	Plasma glucose, insulin and glycosylated haemoglobin (all in mg/dL)
Change in frailty (score)	Baseline to 25 Weeks	Frailty phenotype determination using Fried's criteria
Change in Handgrip strength (kg)	Baseline to 25 Weeks	Using a dynamometer
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 lower-body strength (kg)	Baseline to 25 Weeks	Seated leg press one-repetition maximun test
Change in upper-body strength power output (m/s)	Baseline to 25 Weeks	Vertical bench press load-velocity profile
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 Thyroid-Stimulating Hormone (mIU/L)	Baseline to Week 25
Change in lower-body strength power output (m/s)	Baseline to 25 Weeks	Seated leg press load-velocity profile
Change in lean body mass (kg)	Baseline to Week 25	Change in lean body mass using dual energy x-ray absorptiometry
Change in Disability (Barthel index scores)	Baseline to 25 Weeks	Disability in basic activities of daily living
Change in depression (score)	Baseline to 25 Weeks	Using the 15-item Yesavage geriatric depression

Trial Locations

Locations (1)

Faculty of Sport Sciences; 🇪🇸 Murcia, San Javier, Spain