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

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ClinicalTrials.gov Identifier: NCT02679742
Recruitment Status : Recruiting
First Posted : February 10, 2016
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar

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.

Condition or disease Intervention/treatment Phase
Sarcopenia Dietary Supplement: β-hydroxymethylbutyrate Dietary Supplement: Placebo Phase 2

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 20 patients in each arm of the study. Additionally a one year follow up visit will be performed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The PSSMAR Study (Postacute Sarcopenia, Supplementation With β-hydroxyMethylbutyrate After Resistance Training)
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

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




Primary Outcome Measures :
  1. 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

  2. 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

  3. Change from baseline physical performance at 12 weeks [ Time Frame: From baseline till 12 weeks ]
    Physical performance will be assessed with gait speed in the 4-m walk test

  4. 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 as a percentage of normal values described for Spanish population

  5. Change from baseline physical performance at 12 weeks [ Time Frame: From baseline till 12 weeks ]
    Physical performance will be assessed with gait speed in short physical performance battery


Secondary Outcome Measures :
  1. Number of hospital readmissions [ Time Frame: From baseline till 12 weeks ]
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679742


Contacts
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Contact: Maria Dolores Sánchez-Rodríguez, PhD, MD 00346933268217 97662@parcdesalutmar.cat

Locations
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Spain
Hospital de l'Esperanza Recruiting
Barcelona, Spain, 09024
Sponsors and Collaborators
Parc de Salut Mar
Investigators
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Principal Investigator: Maria Dolores Sánchez-Rodríguez, PhD, MD Parc de Salut Mar
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Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT02679742    
Other Study ID Numbers: PSSMAR 2015/6288/I
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Parc de Salut Mar:
beta hydroxy beta methylbutyrate
older people
muscle mass
muscle strength
post-acute
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical