Title: Maximising Mobility and Strength Training (MMOST) Feasibility Trial
Funder: Department of Health and Social Care

Abstract: Background Frailty is a loss of physiological reserves that makes older people vulnerable to illness or injury. Frail older people are at the highest risk of adverse outcomes, including falls, disability, hospitalisation, the need for long-term care and death. Muscle weakness and poor mobility are common amongst frail older people and those at risk of frailty (pre-frail). Exercise interventions are recommended to address these problems and, therefore, prevent/slow the onset/progression of frailty, with moderate treatment effects observed. It is hypothesised that increasing protein intake in older people with low protein intake ( Aim To establish the feasibility of conducting a randomised controlled trial to evaluate the clinical and cost-effectiveness of mobility and strength training with or without protein supplements for pre-frail and frail community dwelling older adults with low protein intake. Study objectives Establish if we can recruit sufficient numbers of participants Establish intervention fidelity, adherence and tolerance Estimate study retention at 8 months follow up including differential loss to follow up Finalise outcome measures for the main RCT Methods A feasibility RCT conducted in three NHS Community Trusts. Participants will be 50 pre-frail or frail older people living in the community with low protein intake. They will be randomised to an exercise programme of mobility and strength training with and without protein supplements. All participants will undertake exercises 2x/week with physiotherapy support for 6 months using group delivery and independent exercise. Half the participants will receive 6 months of daily protein supplements using home delivery to increase protein intake to 1.6g/kg-body-weight/day. We will test data collection procedures including the proposed primary outcome for the definitive RCT (Short Performance Physical Battery) and secondary outcomes (walking ability, muscle strength and mass, frailty, quality of life and health and social care utilisation) at baseline and 8 months. Outcome assessors will be blinded. We will calculate recruitment, retention and data completion rates and collate and monitor adverse events. We will assess intervention fidelity using treatment logs and observations and adherence based on exercise group attendance and self-report of exercise and protein supplement consumption using diaries. We are working with a patient advisory group. Timelines Pre-grant (3 months): Submit ethical approval Months 0-3: Site set up Months 4-9: Recruitment Months 4-15: Intervention delivery Months 12-17: 8-month follow up Month 18-20: Reporting and definitive RCT protocol development Anticipated Impact and Dissemination Findings will inform an application for a definitive RCT and help other researchers working in this field.

Lay abstract: As people age, loss of muscle size and strength, slower walking, low activity levels, weight loss and feeling tired are common. Older people reporting some or all of these problems may be called frail. Frail people find it harder to get over illness and are more likely to fall or need hospital care. The population is getting older and more people will become frail. We need to find way to stop people becoming frail and allow them to live independently without care and support. Exercise is a treatment for frailty that can improve muscle strength and walking. Including extra protein in an older person s diet may also help. Protein provides the building blocks for muscles but many older people do not eat enough protein. Taking extra protein while exercising may increase the benefits of exercise. However, we do not know if this approach reduces frailty or improves walking and quality of life. We want to conduct a large clinical trial comparing mobility and strength training plus extra protein to training alone in older people with low protein intake. Large trials are expensive and challenging so the aim of this study is to find out if it is possible to carry out this trial and address areas of uncertainty by answering the following questions: Can we recruit enough participants with low protein intake? Does home delivery of protein supplements work? Can physiotherapy departments provide exercise groups and will participants attend? Do participants take the protein supplements and can we monitor this? Can we monitor whether participants exercise regularly at home? Are there any side-effects? How many participants complete the study follow-up assessments? We will work with physiotherapy departments and primary care practices to recruit 50 older people living in the community who are frail or at risk of becoming frail and have low protein intake. Participants will be randomly allocated (like tossing a coin) to mobility and strength training plus protein or training only. Participants will undertake training twice a week with support from a physiotherapist for 6 months. Training involves muscle strengthening, balance and walking exercises. Half the participants will also take extra protein for 6 months (provided using home delivery). At enrolment and 8 months later, we will measure walking ability, balance, muscle strength and size. We will ask participants about quality of life and use of health and social care services. We have an established patient advisory group of older people who helped to develop this application. We will continue to work with them to make sure this research is informed by their real-life experiences. Findings will inform an application for a large clinical trial. Publications and conference presentations will help other researchers working in this field.

Research activity codes: 3.3 NUTRITION AND CHEMOPREVENTION
Health categories: GENERIC HEALTH RELEVANCE