Postacute Sarcopenia: Supplementation With β-hydroxyMethylbutyrate After Resistance Training (PSSMAR)

February 8, 2021 updated by: Parc de Salut Mar

The PSSMAR Study (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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 09024
        • Hospital de l'Esperanza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Investigators

  • Principal Investigator: Maria Dolores Sánchez-Rodríguez, PhD, MD, Parc de Salut Mar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

February 6, 2021

Study Completion (Actual)

February 6, 2021

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

February 5, 2016

First Posted (Estimate)

February 10, 2016

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSSMAR 2015/6288/I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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