Sarcopenia
Conditions
Keywords
beta hydroxy beta methylbutyrate, older people, muscle mass, muscle strength, post-acute
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTβ-hydroxymethylbutyrate
β-hydroxymethylbutyrate 3 grams once a day combined with a resistance training program (3 progressive resistance training sessions per week) during 12 weeks
DIETARY_SUPPLEMENTPlacebo
Maltodextrin 3 grams once a day combined with a resistance training program (3 progressive resistance training sessions per week) during 12 weeks
Sponsors
Parc de Salut Mar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline handgrip strength at 12 weeks | From baseline till 12 weeks | Handgrip strength will be measured by a hand-held dynamometer (JAMAR®, Nottinghamshire, UK) and expressed in Kg |
| Change from baseline physical performance-gait speed- at 12 weeks | From baseline till 12 weeks | Physical performance will be assessed with gait speed in the 4-m walk test |
| Change from baseline physical performance-SPPB- at 12 weeks | From baseline till 12 weeks | Physical performance will be assessed with gait speed in short physical performance battery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute functional gain in 12 weeks | From baseline till 12 weeks | Absolute functional gain measured with Barthel scale |
| Change from baseline rehabilitation impact indices at 12 weeks | From baseline till 12 weeks | Rehabilitation Efficiency Index |
| Relative functional gain in 12 weeks | From baseline till 12 weeks | Relative functional gain measured with Barthel scale |
| Change from baseline lean and fat body mass (muscle mass) at 12 weeks | From baseline till 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 |
| Number of adverse events | From baseline till 12 weeks | Adverse events will be collected by medical interview during the study |
| Number of hospital readmissions | From baseline till 12 weeks | Admissions in acute care due to medical health issues |
| Change from baseline functional status at 12 weeks | From baseline till 12 weeks | Functional status assessed by the Barthel index |
Countries
Spain
Outcome results
None listed