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MMoST Patient Information Sheet and Consent Form

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posted on 2023-10-31, 14:12 authored by Esther WilliamsonEsther Williamson

Background: Frailty is a common syndrome affecting older people and puts them at risk of hospitalisation, needing care or death. First signs of frailty include reduced muscle strength and mobility decline. A key cause of mobility decline as we age is sarcopenia (age related reduction in muscle strength and mass). Poor nutrition contributes to sarcopenia. A shortfall in protein is associated with reduced muscle mass and strength. This may be due to inadequate intake but also because older people have higher protein needs, especially those with multimorbidity. We need to develop effective treatment to reduce or slow the onset of frailty and mobility decline. Exercise is a recommended treatment. Protein supplements to address the shortfall in protein have the potential to enhance the benefit of regular exercise in frail or pre-frail older adults. This has yet to be definitively demonstrated.

Aim: To establish the feasibility of conducting a randomised controlled trial (RCT) evaluating mobility and strength training with or without protein supplements for people over 60 years old who are frail or pre-frail with a low protein intake.

Methods: A multicentre, parallel, 2-group, feasibility RCT. Participants (recruitment target = 50) with problems walking, low protein intake and classified as frail or pre-frail will be recruited from four NHS Physiotherapy community services. Participants will be randomised (secure computer-generated: 1:1) to receive 24 weeks of mobility and strength training (delivered in 16 group sessions plus home exercises) or 24 weeks of mobility and strength training with daily protein supplements. Primary feasibility objectives are to estimate 1) ability to screen and recruit eligible participants, 2) intervention fidelity, adherence, and tolerance and 3) retention of participants at follow up. Secondary objectives are to 1) test data collection procedures, 2) assess data completeness and 3) confirm sample size calculation for a definitive RCT.

Registration: Registered on the ISRCTN Registry on the 18/10/2022: https://doi.org/10.1186/ISRCTN30405954

Funding

NIHR Research for Patient Benefit NIHR202733

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    Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences

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