Effects of β-hydroxy-β-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

Abstract

Background Evidence supports the fact that multicomponent exercise and HMB supplementation are, separately, effective in improving older adult’s health and palliate functional metabolic diseases in older people. However, the true effect of HMB supplementation combined with a tailored exercise program in frail older adults is still unknown. Thus, the aim of the HEAL (HMB + Exercise = Adults Living longer) study is to assess the effects of the combination of a daily multicomponent exercise and resistance training (VIVIFRAIL program) intervention in addition to HMB supplementation on older adults’ health. Methods/design A 24-week cluster randomized, double-blind, placebo-controlled study will be conducted on 104 adults ≥70 years. Nursing homes will be randomized to either of four groups: Ex-HMB (exercise intervention with HMB), Ex-Plac (exercise intervention with placebo), NoEx-HMB (no exercise intervention with HMB), and Controls (No exercise and no HMB). Intervention groups which include exercise will complete the individualized multicomponent (strength, balance and cardiovascular exercises) training program VIVIFRAIL. Intervention groups which include HMB supplementation will receive a 3 g/daily dose of free acid HMB in powder form. The primary outcome measure is the functional capacity. Secondary outcome measures are muscle strength and power, frailty and fall risk, body composition, biochemical analyses and cardiometabolic risk factor, disability and comorbidity, cognitive function and depression. Discussion The findings of the HEAL study will help professionals from public health systems to identify cost-effective and innovative actions to improve older people’s health and quality of life, and endorse exercise practice in older adults and people living in nursing homes. Trial registration NCT03827499 ; Date of registration: 01/02/2019.

Health Benefits of β-Hydroxy-β-Methylbutyrate (HMB) Supplementation in Addition to Physical Exercise in Older Adults: A Systematic Review with Meta-Analysis

“…Thus, it seems that HMB supplementation in addition to exercise would be particularly effective to optimize physical rehabilitation treatments and accelerate mobility recovery in frail people and muscle wasting conditions. Although evidence supporting the positive impact of HMB to enhance exercise training adaptations and increase health benefits in frail or sarcopenic people is lacking, the results of ongoing clinical trials [54,55,56] will likely provide additional evidence in the near future to support treatment choices for older people.…”

Supervised Exercise (Vivifrail) Protects Institutionalized Older Adults Against Severe Functional Decline After 14 Weeks of COVID Confinement

“…This study is part of an ongoing multicenter trial (NCT03827499). 9 Participants enrolled into one of the individualized Vivifrail training programs according to their frailty level: Disability (A), Frailty (B), Pre-frailty (C), and Robust (D). Exercise regimen and weight load were set according to the Vivifrail prescription guidelines (http://vivifrail.com/resources/).…”

A Sensitive and Practical Evaluation to Detect Lower-Limb Strength Changes in Geriatrics: The Isometric Knee Extension Test

“…This research was part of the HEAL study, an ongoing multicenter randomized controlled trial [27]. Older adults living in nursing homes completed 4 weeks of the tailored multicomponent exercise program Vivifrail [28].…”

“…The characteristics of the sample analyzed in the exercise and inactivity periods are detailed in Table 1. The inclusion and exclusion criteria were set according to the Vivifrail exercise program and HEAL study [27]. The study, which was conducted according to the Declaration of Helsinki, was approved by the Ethics Commission of the Local University (ID: 2131/2018).…”