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NCT Number: NCT02679742

Postacute Sarcopenia: Supplementation With β-hydroxyMethylbutyrate After Resistance Training

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de l'Esperanza

Barcelona, 09024, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

β-hydroxymethylbutyrate

Dietary Supplement

β-hydroxymethylbutyrate 3 grams once a day combined with a resistance training program (3 progressive resistance training sessions per week) during 12 weeks

Placebo

Dietary Supplement

Maltodextrin 3 grams once a day combined with a resistance training program (3 progressive resistance training sessions per week) during 12 weeks

Primary outcomes

  1. Change from baseline handgrip strength at 12 weeks

    Time frame: From baseline till 12 weeks

    Handgrip strength will be measured by a hand-held dynamometer (JAMAR®, Nottinghamshire, UK) and expressed in Kg

  2. Change from baseline physical performance-gait speed- at 12 weeks

    Time frame: From baseline till 12 weeks

    Physical performance will be assessed with gait speed in the 4-m walk test

  3. Change from baseline physical performance-SPPB- at 12 weeks

    Time frame: From baseline till 12 weeks

    Physical performance will be assessed with gait speed in short physical performance battery

Secondary outcomes

  1. Number of hospital readmissions

    Time frame: From baseline till 12 weeks

    Admissions in acute care due to medical health issues

  2. Change from baseline functional status at 12 weeks

    Time frame: From baseline till 12 weeks

    Functional status assessed by the Barthel index

  3. Absolute functional gain in 12 weeks

    Time frame: From baseline till 12 weeks

    Absolute functional gain measured with Barthel scale

  4. Relative functional gain in 12 weeks

    Time frame: From baseline till 12 weeks

    Relative functional gain measured with Barthel scale

  5. Change from baseline rehabilitation impact indices at 12 weeks

    Time frame: From baseline till 12 weeks

    Rehabilitation Efficiency Index

  6. Number of adverse events

    Time frame: From baseline till 12 weeks

    Adverse events will be collected by medical interview during the study

  7. Change from baseline lean and fat body mass (muscle mass) at 12 weeks

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study title

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

Acronym: PSSMAR

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 10, 2016
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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