Postacute Sarcopenia: Supplementation With β-hydroxyMethylbutyrate After Resistance Training

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The PSSMAR Study (Postacute Sarcopenia, Supplementation With β-hydroxyMethylbutyrate After Resistance Training)

Conditions
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Sarcopenia

Intervention / Treatment
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* Dietary Supplement: β-hydroxymethylbutyrate
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female ≥60 years old sarcopenia diagnosis and case-finding criteria following European Working Group On Sarcopenia in Older People (EWGSOP) being discharged from post-acute care geriatric unit for rehabilitation treatment ambulatory prior to the recent acute process cognitive situation that let them to understand and follow an active physical rehabilitation program (Mini-Mental Status Examination ≥21/30) voluntary participation and being able and willing to provide an informed consent Exclusion Criteria: potential participants will be excluded if they have active malignancy (exception basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix) major lower limb surgery over the past 6 months (knee or hip arthroplasty) contraindication for resistance training performed regular exercise in the last 6 months use of any medications interfering with the nutritional intervention serious clinical conditions that compromises and endanger the patient's life contraindication, intolerance or allergy to β-hydroxymethylbutyrate

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: β-hydroxymethylbutyrate<br>β-hydroxymethylbutyrate 3 grams once a day combined with a resistance training program | Dietary Supplement: β-hydroxymethylbutyrate<br>* β-hydroxymethylbutyrate 3 grams once a day combined with a resistance training program (3 progressive resistance training sessions per week) during 12 weeks<br>|
| Placebo Comparator: Placebo<br>Maltodextrin 3 grams once a day combined with a resistance training program | Dietary Supplement: Placebo<br>* Maltodextrin 3 grams once a day combined with a resistance training program (3 progressive resistance training sessions per week) during 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | From baseline till 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospital readmissions | Admissions in acute care due to medical health issues | From baseline till 12 weeks | 
| Change from baseline functional status at 12 weeks | Functional status assessed by the Barthel index | From baseline till 12 weeks | 
| Absolute functional gain in 12 weeks | Absolute functional gain measured with Barthel scale | From baseline till 12 weeks | 
| Relative functional gain in 12 weeks | Relative functional gain measured with Barthel scale | From baseline till 12 weeks | 
| Change from baseline rehabilitation impact indices at 12 weeks | Rehabilitation Efficiency Index | From baseline till 12 weeks | 
| Number of adverse events | Adverse events will be collected by medical interview during the study | 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 | From baseline till 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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beta hydroxy beta methylbutyrate, older people, muscle mass, muscle strength, post-acute