Clinical trial NCT03827499: HMB Supplementation in Addition to Multicomponent Exercise in Old Adults
Official title: Effects of β-hydroxy-β-methylbutyrate (HMB) Supplementation in Addition to Multicomponent Exercise in Old Adults Living in Nursing Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Frail Elderly Syndrome
Physical Activity
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 104
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in physical functional performance based on the Short Physical Performance Battery (SPPB) score
timeFrame: Baseline to 25 Weeks
Secondary outcomes:
measure: Change in Handgrip strength (kg)
timeFrame: Baseline to 25 Weeks
measure: Change in lower-body strength (kg)
timeFrame: Baseline to 25 Weeks
measure: Change in upper-body strength (kg)
timeFrame: Baseline to 25 Weeks
measure: Change in lower-body strength power output (m/s)
timeFrame: Baseline to 25 Weeks
measure: Change in upper-body strength power output (m/s)
timeFrame: Baseline to 25 Weeks
measure: Change in frailty (score)
timeFrame: Baseline to 25 Weeks
measure: Change in lean body mass (kg)
timeFrame: Baseline to Week 25
measure: Change in lipid profile
timeFrame: Baseline to Week 25
measure: Change in glycaemic profile
timeFrame: Baseline to Week 25
measure: Change in Thyroid-Stimulating Hormone (mIU/L)
timeFrame: Baseline to Week 25
measure: Change in Disability (Lawton index scores)
timeFrame: Baseline to 25 Weeks
measure: Change in Disability (Barthel index scores)
timeFrame: Baseline to 25 Weeks
measure: Change in Comorbidity (score)
timeFrame: Baseline to 25 Weeks
measure: Change in cognitive function (score)
timeFrame: Baseline to 25 Weeks
measure: Change in depression (score)
timeFrame: Baseline to 25 Weeks
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Faculty of Sport Sciences
state: San Javier
Study officials:
References:
citation: Courel-Ibanez J, Pallares JG; HEAL study group. Effects of beta-hydroxy-beta-methylbutyrate (HMB) supplementation in addition to multicomponent exercise in adults older than 70 years living in nursing homes, a cluster randomized placebo-controlled trial: the HEAL study protocol. BMC Geriatr. 2019 Jul 5;19(1):188. doi: 10.1186/s12877-019-1200-5.