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

Primary Purpose

Sarcopenia

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

β-hydroxymethylbutyrate

Placebo

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring beta hydroxy beta methylbutyrate, older people, muscle mass, muscle strength, post-acute

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital de l'Esperanza

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

β-hydroxymethylbutyrate

Placebo

Arm Description

β-hydroxymethylbutyrate 3 grams once a day combined with a resistance training program

Maltodextrin 3 grams once a day combined with a resistance training program

Outcomes

Primary Outcome Measures

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

Change from baseline physical performance-gait speed- at 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

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

Secondary Outcome Measures

Number of hospital readmissions

Admissions in acute care due to medical health issues

Change from baseline functional status at 12 weeks

Functional status assessed by the Barthel index

Absolute functional gain in 12 weeks

Absolute functional gain measured with Barthel scale

Relative functional gain in 12 weeks

Relative functional gain measured with Barthel scale

Change from baseline rehabilitation impact indices at 12 weeks

Rehabilitation Efficiency Index

Number of adverse events

Adverse events will be collected by medical interview during the study

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

Full Information

NCT ID

NCT02679742

First Posted

January 26, 2016

Last Updated

February 8, 2021

Sponsor

Parc de Salut Mar

1. Study Identification

Unique Protocol Identification Number

NCT02679742

Brief Title

Postacute Sarcopenia: Supplementation With β-hydroxyMethylbutyrate After Resistance Training

Acronym

PSSMAR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

February 6, 2021 (Actual)

Study Completion Date

February 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Parc de Salut Mar

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcopenia

Keywords

beta hydroxy beta methylbutyrate, older people, muscle mass, muscle strength, post-acute

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

β-hydroxymethylbutyrate

Arm Type

Experimental

Arm Description

β-hydroxymethylbutyrate 3 grams once a day combined with a resistance training program

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Maltodextrin 3 grams once a day combined with a resistance training program

Intervention Type

Dietary Supplement

Intervention Name(s)

β-hydroxymethylbutyrate

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline handgrip strength at 12 weeks

Description

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

Time Frame

From baseline till 12 weeks

Title

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

Description

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

Time Frame

From baseline till 12 weeks

Title

Change from baseline physical performance-SPPB- at 12 weeks

Description

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

Time Frame

From baseline till 12 weeks

Secondary Outcome Measure Information:

Title

Number of hospital readmissions

Description

Admissions in acute care due to medical health issues

Time Frame

From baseline till 12 weeks

Title

Change from baseline functional status at 12 weeks

Description

Functional status assessed by the Barthel index

Time Frame

From baseline till 12 weeks

Title

Absolute functional gain in 12 weeks

Description

Absolute functional gain measured with Barthel scale

Time Frame

From baseline till 12 weeks

Title

Relative functional gain in 12 weeks

Description

Relative functional gain measured with Barthel scale

Time Frame

From baseline till 12 weeks

Title

Change from baseline rehabilitation impact indices at 12 weeks

Description

Rehabilitation Efficiency Index

Time Frame

From baseline till 12 weeks

Title

Number of adverse events

Description

Adverse events will be collected by medical interview during the study

Time Frame

From baseline till 12 weeks

Title

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

Description

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

Time Frame

From baseline till 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Dolores Sánchez-Rodríguez, PhD, MD

Organizational Affiliation

Parc de Salut Mar

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital de l'Esperanza

City

Barcelona

ZIP/Postal Code

09024

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27823730

Citation

Sanchez-Rodriguez D, Marco E, Ronquillo-Moreno N, Miralles R, Mojal S, Vazquez-Ibar O, Escalada F, Muniesa JM. The PSSMAR study. Postacute sarcopenia: Supplementation with beta-hydroxyMethylbutyrate after resistance training: Study protocol of a randomized, double-blind controlled trial. Maturitas. 2016 Dec;94:117-124. doi: 10.1016/j.maturitas.2016.08.019. Epub 2016 Sep 9. No abstract available.

Results Reference

background

PubMed Identifier

32737844

Citation

Reginster JY, Beaudart C, Al-Daghri N, Avouac B, Bauer J, Bere N, Bruyere O, Cerreta F, Cesari M, Rosa MM, Cooper C, Cruz Jentoft AJ, Dennison E, Geerinck A, Gielen E, Landi F, Laslop A, Maggi S, Prieto Yerro MC, Rizzoli R, Sundseth H, Sieber C, Trombetti A, Vellas B, Veronese N, Visser M, Vlaskovska M, Fielding RA. Update on the ESCEO recommendation for the conduct of clinical trials for drugs aiming at the treatment of sarcopenia in older adults. Aging Clin Exp Res. 2021 Jan;33(1):3-17. doi: 10.1007/s40520-020-01663-4. Epub 2020 Jul 31.

Results Reference

background

PubMed Identifier

26051706

Citation

Sanchez-Rodriguez D, Marco E, Miralles R, Guillen-Sola A, Vazquez-Ibar O, Escalada F, Muniesa JM. Does gait speed contribute to sarcopenia case-finding in a postacute rehabilitation setting? Arch Gerontol Geriatr. 2015 Sep-Oct;61(2):176-81. doi: 10.1016/j.archger.2015.05.008. Epub 2015 May 29.

Results Reference

background

PubMed Identifier

24726179

Citation

Sanchez-Rodriguez D, Marco E, Miralles R, Fayos M, Mojal S, Alvarado M, Vazquez-Ibar O, Escalada F, Muniesa JM. Sarcopenia, physical rehabilitation and functional outcomes of patients in a subacute geriatric care unit. Arch Gerontol Geriatr. 2014 Jul-Aug;59(1):39-43. doi: 10.1016/j.archger.2014.02.009. Epub 2014 Mar 1.

Results Reference

background

PubMed Identifier

31789867

Citation

Sanchez-Rodriguez D, Marco E, Cruz-Jentoft AJ. Defining sarcopenia: some caveats and challenges. Curr Opin Clin Nutr Metab Care. 2020 Mar;23(2):127-132. doi: 10.1097/MCO.0000000000000621.

Results Reference

background

PubMed Identifier

30312372

Citation

Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169. Erratum In: Age Ageing. 2019 Jul 1;48(4):601.

Results Reference

background

PubMed Identifier

31233072

Citation

Sanchez-Rodriguez D, Marco E, Davalos-Yerovi V, Lopez-Escobar J, Messaggi-Sartor M, Barrera C, Ronquillo-Moreno N, Vazquez-Ibar O, Calle A, Inzitari M, Piotrowicz K, Duran X, Escalada F, Muniesa JM, Duarte E. Translation and Validation of the Spanish Version of the SARC-F Questionnaire to Assess Sarcopenia in Older People. J Nutr Health Aging. 2019;23(6):518-524. doi: 10.1007/s12603-019-1204-z.

Results Reference

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Postacute Sarcopenia: Supplementation With β-hydroxyMethylbutyrate After Resistance Training

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