MET-PREVENT: metformin to improve physical performance in older people with sarcopenia and physical prefrailty/frailty – protocol for a double-blind, randomised controlled proof-of-concept trial
Introduction Skeletal muscle dysfunction is central to both sarcopenia and physical frailty, which are associated with a wide range of adverse outcomes including falls and fractures, longer hospital stays, dependency and the need for care. Resistance training may prevent and treat sarcopenia and phy...
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BMJ Publishing Group
2022-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/7/e061823.full |
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| author | Andrew Clegg James Wason Miles Witham Nina Wilson Claire J Steves Helen C Hancock Avan A P Sayer Leanne Marsay Claire McDonald Thomas von Zglinicki Katherine J Rennie Penny Bradley Stephen Connolly Shaun Hiu Laura Robertson Laura Simms Alison J Steel Bryony Storey |
| author_facet | Andrew Clegg James Wason Miles Witham Nina Wilson Claire J Steves Helen C Hancock Avan A P Sayer Leanne Marsay Claire McDonald Thomas von Zglinicki Katherine J Rennie Penny Bradley Stephen Connolly Shaun Hiu Laura Robertson Laura Simms Alison J Steel Bryony Storey |
| author_sort | Andrew Clegg |
| collection | DOAJ |
| description | Introduction Skeletal muscle dysfunction is central to both sarcopenia and physical frailty, which are associated with a wide range of adverse outcomes including falls and fractures, longer hospital stays, dependency and the need for care. Resistance training may prevent and treat sarcopenia and physical frailty, but not everyone can or wants to exercise. Finding alternatives is critical to alleviate the burden of adverse outcomes associated with sarcopenia and physical frailty. This trial will provide proof-of-concept evidence as to whether metformin can improve physical performance in older people with sarcopenia and physical prefrailty or frailty.Methods and analysis MET-PREVENT is a parallel group, double-blind, placebo-controlled proof-of-concept trial. Trial participants can participate from their own homes, including completing informed consent and screening assessments. Eligible participants with low grip strength or prolonged sit-to-stand time together with slow walk speed will be randomised to either oral metformin hydrochloride 500 mg tablets or matched placebo, taken three times a day for 4 months. The recruitment target is 80 participants from two secondary care hospitals in Newcastle and Gateshead, UK. Local primary care practices will act as participant identification centres. Randomisation will be performed using a web-based minimisation system with a random element, balancing on sex and baseline walk speed. Participants will be followed up for 4 months post-randomisation, with outcomes collected at baseline and 4 months. The primary outcome measure is the four metre walk speed at the 4-month follow-up visit.Ethics and dissemination The trial has been approved by the Liverpool NHS Research Ethics Committee (20/NW/0470), the Medicines and Healthcare Regulatory Authority (EudraCT 2020-004023-16) and the UK Health Research Authority (IRAS 275219). Results will be made available to participants, their families, patients with sarcopenia, the public, regional and national clinical teams, and the international scientific community.Trial registration number ISRCTN29932357. |
| format | Article |
| id | doaj-art-c38312c1f822459d9cd55223ecbacea3 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-c38312c1f822459d9cd55223ecbacea32025-01-31T07:45:10ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2022-061823MET-PREVENT: metformin to improve physical performance in older people with sarcopenia and physical prefrailty/frailty – protocol for a double-blind, randomised controlled proof-of-concept trialAndrew Clegg0James Wason1Miles Witham2Nina Wilson3Claire J Steves4Helen C Hancock5Avan A P Sayer6Leanne Marsay7Claire McDonald8Thomas von Zglinicki9Katherine J Rennie10Penny Bradley11Stephen Connolly12Shaun Hiu13Laura Robertson14Laura Simms15Alison J Steel16Bryony Storey17Health Technology Assessment Group, University of Central Lancashire, Preston, Lancashire, UKMRC Biostatistics Unit, University of Cambridge, UKNIHR Newcastle Biomedical Research Centre, Newcastle upon Tyne NHS Foundation Trust, Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust and Newcastle University, Newcastle upon Tyne, UKPopulation Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UKThe Department of Twin Research & Genetic Epidemiology, King`s College London, London, UKNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UKNIHR Newcastle Biomedical Research Centre, Newcastle University and Newcastle Hospitals NHS Foundation Trust, Newcastle upon Tyne, UKNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UKGateshead Health NHS Foundation Trust, Gateshead, UKBiosciences Institute, Newcastle University, Newcastle upon Tyne, UKNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK4 Pharmacy Clinical Trials, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UKPatient and Public Involvement Representative, Newcastle upon Tyne, UKPopulation Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UKNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UKNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UKNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UKGateshead Health NHS Foundation Trust, Gateshead, UKIntroduction Skeletal muscle dysfunction is central to both sarcopenia and physical frailty, which are associated with a wide range of adverse outcomes including falls and fractures, longer hospital stays, dependency and the need for care. Resistance training may prevent and treat sarcopenia and physical frailty, but not everyone can or wants to exercise. Finding alternatives is critical to alleviate the burden of adverse outcomes associated with sarcopenia and physical frailty. This trial will provide proof-of-concept evidence as to whether metformin can improve physical performance in older people with sarcopenia and physical prefrailty or frailty.Methods and analysis MET-PREVENT is a parallel group, double-blind, placebo-controlled proof-of-concept trial. Trial participants can participate from their own homes, including completing informed consent and screening assessments. Eligible participants with low grip strength or prolonged sit-to-stand time together with slow walk speed will be randomised to either oral metformin hydrochloride 500 mg tablets or matched placebo, taken three times a day for 4 months. The recruitment target is 80 participants from two secondary care hospitals in Newcastle and Gateshead, UK. Local primary care practices will act as participant identification centres. Randomisation will be performed using a web-based minimisation system with a random element, balancing on sex and baseline walk speed. Participants will be followed up for 4 months post-randomisation, with outcomes collected at baseline and 4 months. The primary outcome measure is the four metre walk speed at the 4-month follow-up visit.Ethics and dissemination The trial has been approved by the Liverpool NHS Research Ethics Committee (20/NW/0470), the Medicines and Healthcare Regulatory Authority (EudraCT 2020-004023-16) and the UK Health Research Authority (IRAS 275219). Results will be made available to participants, their families, patients with sarcopenia, the public, regional and national clinical teams, and the international scientific community.Trial registration number ISRCTN29932357.https://bmjopen.bmj.com/content/12/7/e061823.full |
| spellingShingle | Andrew Clegg James Wason Miles Witham Nina Wilson Claire J Steves Helen C Hancock Avan A P Sayer Leanne Marsay Claire McDonald Thomas von Zglinicki Katherine J Rennie Penny Bradley Stephen Connolly Shaun Hiu Laura Robertson Laura Simms Alison J Steel Bryony Storey MET-PREVENT: metformin to improve physical performance in older people with sarcopenia and physical prefrailty/frailty – protocol for a double-blind, randomised controlled proof-of-concept trial BMJ Open |
| title | MET-PREVENT: metformin to improve physical performance in older people with sarcopenia and physical prefrailty/frailty – protocol for a double-blind, randomised controlled proof-of-concept trial |
| title_full | MET-PREVENT: metformin to improve physical performance in older people with sarcopenia and physical prefrailty/frailty – protocol for a double-blind, randomised controlled proof-of-concept trial |
| title_fullStr | MET-PREVENT: metformin to improve physical performance in older people with sarcopenia and physical prefrailty/frailty – protocol for a double-blind, randomised controlled proof-of-concept trial |
| title_full_unstemmed | MET-PREVENT: metformin to improve physical performance in older people with sarcopenia and physical prefrailty/frailty – protocol for a double-blind, randomised controlled proof-of-concept trial |
| title_short | MET-PREVENT: metformin to improve physical performance in older people with sarcopenia and physical prefrailty/frailty – protocol for a double-blind, randomised controlled proof-of-concept trial |
| title_sort | met prevent metformin to improve physical performance in older people with sarcopenia and physical prefrailty frailty protocol for a double blind randomised controlled proof of concept trial |
| url | https://bmjopen.bmj.com/content/12/7/e061823.full |
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