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

TY - JOUR

T1 - MET-PREVENT

T2 - 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

AU - Rennie, Katherine J.

AU - Witham, Miles

AU - Bradley, Penny

AU - Clegg, Andrew

AU - Connolly, Stephen

AU - Hancock, Helen C.

AU - Hiu, Shaun

AU - Marsay, Leanne

AU - McDonald, Claire

AU - Robertson, Laura

AU - Simms, Laura

AU - Steel, Alison J.

AU - Steves, Claire J.

AU - Storey, Bryony

AU - Wason, James

AU - Wilson, Nina

AU - Von Zglinicki, Thomas

AU - Sayer, Avan A.P.

N1 - Funding Information: This work was supported by the NIHR Newcastle Biomedical Research Centre, reference NU001533. Publisher Copyright: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2022/7/18

Y1 - 2022/7/18

N2 - 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.

AB - 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.

KW - CLINICAL PHARMACOLOGY

KW - GERIATRIC MEDICINE

KW - REHABILITATION MEDICINE

UR - http://www.scopus.com/inward/record.url?scp=85134552644&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2022-061823

DO - 10.1136/bmjopen-2022-061823

M3 - Article

C2 - 35851031

AN - SCOPUS:85134552644

SN - 2044-6055

VL - 12

JO - BMJ Open

JF - BMJ Open

IS - 7

M1 - e061823

ER -