HMB Supplementation in Addition to Multicomponent Exercise in Old Adults (HEAL)

Universidad de Murcia

Status: Completed

Conditions: Aging; Physical Activity; Frail Elderly Syndrome

Treatments: Other: Multicomponent physical exercise program; Dietary Supplement: HMB dietary supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT03827499

2131/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

104 participants in 4 patient groups, including a placebo group

Ex-HMB

Experimental group

Description:

HMB dietary supplementation and Multicomponent physical exercise program

Treatment:

Dietary Supplement: HMB dietary supplementation

Other: Multicomponent physical exercise program

NoEx-HMB

Experimental group

Description:

HMB Dietary supplementation

Treatment:

Dietary Supplement: HMB dietary supplementation

Ex-Plac

Placebo Comparator group

Description:

Multicomponent physical exercise program

Treatment:

Other: Multicomponent physical exercise program

Controls

No Intervention group

Description:

No intervention