Informed consent form for the LACE trial. (PDF 29Â kb

Adrian Hapca (4737204)

Alison Avenell (82040)

Allan Struthers (354326)

Cheryl Hume (4737198)

Deepa Sumukadas (4737207)

Karen Smith (71943)

Margaret Band (4737201)

Miles Witham (4355218)

Paul Kemp (435674)

Peter Donnan (3494072)

Trials

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Additional file 1: of Leucine and ACE inhibitors as therapies for sarcopenia (LACE trial): study protocol for a randomised controlled trial

Abstract Background Sarcopenia (the age-related loss of muscle mass and function) is a major contributor to loss of mobility, falls, loss of independence, morbidity and mortality in older people. Although resistance training is effective in preventing and reversing sarcopenia, many older people are sedentary and either cannot or do not want to exercise. This trial examines the efficacy of supplementation with the amino acid leucine and/or angiotensin converting enzyme inhibition to potentially improve muscle mass and function in people with sarcopenia. Promising preliminary data exist from small studies for both interventions, but neither has yet been tested in adequately powered randomised trials in patients with sarcopenia. Methods Leucine and ACE inhibitors in sarcopenia (LACE) is a multicentre, masked, placebo-controlled, 2 × 2 factorial randomised trial evaluating the efficacy of leucine and perindopril (angiotensin converting enzyme inhibitor (ACEi)) in patients with sarcopenia. The trial will recruit 440 patients from primary and secondary care services across the UK. Male and female patients aged 70 years and over with sarcopenia as defined by the European Working Group on Sarcopenia (based on low total skeletal muscle mass on bioimpedance analysis and either low gait speed or low handgrip strength) will be eligible for participation. Participants will be excluded if they have a contraindication to, or are already taking, an ACEi, angiotensin receptor blocker or leucine. The primary clinical outcome for the trial is the between-group difference in the Short Physical Performance Battery score at all points between baseline and 12 months. Secondary outcomes include appendicular muscle mass measured using dual-energy X-ray absorptiometry, muscle strength, activities of daily living, quality of life, activity using pedometer step counts and falls. Participants, clinical teams, outcomes assessors and trial analysts are masked to treatment allocation. A panel of biomarkers including microRNAs, neurohormones, genetic polymorphisms and markers of inflammation relevant to muscle pathophysiology will be measured to explore predictors of response and further elucidate mechanisms underlying sarcopenia. Participants will receive a total of 12 months of either perindopril or placebo and either leucine or placebo. Discussion The results will provide the first robust test of the overall clinical and cost-effectiveness of these novel therapies for older patients with sarcopenia. Trial registration ISRCTN, ISRCTN90094835 . Registered on 18 February 2015

Margaret M. Band

Deepa Sumukadas

Allan D. Struthers

Alison Avenell

Peter T. Donnan

Paul R. Kemp

Karen T. Smith

Cheryl L. Hume

Adrian Hapca

Miles D. Witham

Directory of Open Access Journals

Leucine and ACE inhibitors as therapies for sarcopenia (LACE trial): study protocol for a randomised controlled trial

This project is funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership (grant number 13/53/03). The views expressed in this publication are those of the author(s) and not necessarily those of the MRC, NHS, NIHR or Department of Health. The authors acknowledge the financial assistance and support of the NIHR Ageing Clinical Research Network and acknowledge support from the Chief Scientist Office, Scottish Government Support for Science funding stream. The Health Services Research Unit is core funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates.Peer reviewe

Band, Margaret M

Sumukadas, Deepa

Struthers, Allan D

Avenell, Alison

Donnan, Peter T

Kemp, Paul R

Smith, Karen T

Hume, Cheryl L

Hapca, Adrian

Witham, Miles D

Aberdeen University Research

English

Leucine and ACE inhibitors as therapies for sarcopenia (LACE trial) : study protocol for a randomised controlled trial

Gautier, Philippe

DIAL UCLouvain

Rapport belge

Crossref

Participant information leaflet for the LACE trial. (PDF 467Â kb

Additional file 2: of Leucine and ACE inhibitors as therapies for sarcopenia (LACE trial): study protocol for a randomised controlled trial

Background: Sarcopenia (the age related loss of muscle mass and function) is a major contributor to loss of mobility, falls, loss of independence, morbidity and mortality in older people. Although resistance training is effective in preventing and reversing sarcopenia, many older people are sedentary and either cannot, or do not want to exercise. This trial examines the efficacy of supplementation with the amino acid leucine and/or angiotensin converting enzyme inhibition to potentially improve muscle mass and function in people with sarcopenia. Promising preliminary data exists from small studies for both interventions, but neither have yet been tested in adequately powered randomised trials in patients with sarcopenia.Methods: Leucine and ACE inhibitors in sarcopenia (LACE) is a multi-centre, masked, placebo-controlled, 2x2 factorial randomised trial evaluating the efficacy of leucine and perindopril (ACEi) in patients with sarcopenia. The trial will recruit 440 patients from primary and secondary care services across the UK. Male and female patients aged 70 years and over with sarcopenia as defined by the European Working Group on Sarcopenia (based on low total skeletal muscle mass on Bioimpedance Analysis and either low gait speed or low handgrip strength) will be eligible for participation. Participants will be excluded if they have a contraindication to, or are already taking, an ACEi, angiotensin receptor blocker or leucine. The primary clinical outcome for the trial is the between-group difference in the Short Physical Performance Battery score at all points between baseline and 12 months. Secondary outcomes include appendicular muscle mass measured using dual energy X-ray absorptiometry, muscle strength, activities of daily living, quality of life, activity using pedometer step counts, and falls. Participants, clinical teams, outcomes assessors and trial analysts are masked to treatment allocation. A panel of biomarkers including micro RNAs, neurohormones, genetic polymorphisms and markers of inflammation relevant to muscle pathophysiology will be measured to explore predictors of response and further elucidate mechanisms underlying sarcopenia. Participants will receive a total of 12 months of either perindopril or placebo and either leucine or placebo. Discussion: The results will provide the first robust test of the overall clinical and cost-effectiveness of these novel therapies for older patients with sarcopenia.<br/

Band, Margaret M.

Struthers, Allan D.

Donnan, Peter T.

Kemp, Paul R.

Smith, Karen T.

Hume, Cheryl L.

Witham, Miles D.

University of Dundee Online Publications

Leucine and ACE inhibitors as therapies for sarcopenia (LACE trial):study protocol for a randomised controlled trial

https://aura.abdn.ac.uk/bitstream/2164/9948/1/Leucine_and_ACE_inhibitors_as_therapies_for_sarcopenia_LACE_trial_study_protocol_for_a_randomised_controlled_trial.pdf

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University of Dundee Online Publications

University of Dundee Online Publications