A randomized, double-blind, placebo-controlled, parallel study to assess the effects of β-hydroxymethylbutyrate (β-HMB) combined with a resistance training program, after an acute process in older patients with sarcopenia in terms of muscle mass, muscle strength and physical performance. Treatments compared will be β-hydroxymethylbutyrate (β-HMB) with a resistance training program or placebo with a resistance training program.
Sarcopenia is a geriatric syndrome characterized by the loss of skeletal muscle mass and strength that occurs with advancing age; it is related to frailty, falls, worsening quality of life, and death in chronic and elderly patients. Diagnosis of sarcopenia is based on clinical criteria: presence of low muscle mass and the presence of low muscle function and/or low physical performance. The latest developments indicate that dietary supplementation combined with resistance exercise could be an option to improve muscle mass and function. The objective of the study is to assess the effects of β-hydroxymethylbutyrate (β-HMB) combined with a resistance training program, after an acute process in older patients with sarcopenia in terms of muscle mass, muscle strength and physical performance. Design: A randomized, double-blind, placebo-controlled, parallel study with two intervention groups. The investigators shall compare placebo against an intervention with β-HMB in patients performing a resistance training program after an acute process (post-acute period) during 12 weeks. There will be 16 patients in each arm of the study. Additionally a one year follow up visit will be performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
β-hydroxymethylbutyrate 3 grams once a day combined with a resistance training program (3 progressive resistance training sessions per week) during 12 weeks
Maltodextrin 3 grams once a day combined with a resistance training program (3 progressive resistance training sessions per week) during 12 weeks
Hospital de l'Esperanza
Barcelona, Spain
Change from baseline handgrip strength at 12 weeks
Handgrip strength will be measured by a hand-held dynamometer (JAMAR®, Nottinghamshire, UK) and expressed in Kg
Time frame: From baseline till 12 weeks
Change from baseline physical performance-gait speed- at 12 weeks
Physical performance will be assessed with gait speed in the 4-m walk test
Time frame: From baseline till 12 weeks
Change from baseline physical performance-SPPB- at 12 weeks
Physical performance will be assessed with gait speed in short physical performance battery
Time frame: From baseline till 12 weeks
Number of hospital readmissions
Admissions in acute care due to medical health issues
Time frame: From baseline till 12 weeks
Change from baseline functional status at 12 weeks
Functional status assessed by the Barthel index
Time frame: From baseline till 12 weeks
Absolute functional gain in 12 weeks
Absolute functional gain measured with Barthel scale
Time frame: From baseline till 12 weeks
Relative functional gain in 12 weeks
Relative functional gain measured with Barthel scale
Time frame: From baseline till 12 weeks
Change from baseline rehabilitation impact indices at 12 weeks
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Rehabilitation Efficiency Index
Time frame: From baseline till 12 weeks
Number of adverse events
Adverse events will be collected by medical interview during the study
Time frame: From baseline till 12 weeks
Change from baseline lean and fat body mass (muscle mass) at 12 weeks
Lean and fat body mass will be measured by electrical impedance measured in kg and expressed as normal, low or high values according to normality values for the European population
Time frame: From baseline till 12 weeks