The EXPRESS pilot study: EXercise and PRotein Supplementation Supporting Autonomy in Prefrail & Frail Community Residing adults aged 65 years or older

INTERVENTION: Study is a randomised, parallel, control pilot study conducted over 6 months with participants being assessed at baseline, at 3 months and at 6 months. Participants will be randomly assigned to one of 2 treatments: 1) twice daily 20 g rice protein supplements combined with a multi‐component exercise program (n=60); and 2) twice daily 20 g whey protein supplements combined with a multi‐component exercise program (n=60). The nutrition prescription will be given by a qualified dietitian from CSIRO Food and Nutrition Unit. All protein supplements will be provided as a powder in individual 26 g sachets to provide 20 g of protein when reconstituted in 150 ml of water. All drinks will be isocaloric and isonitrogeneous and of comparable taste, texture and aroma. The exercise program, which will commence at the same time as the protein supplementation, consists of a combination of aerobic, resistance, balance and flexibility exercises that will be performed once per week as a central gym‐based group session and also three to five times a week at home. The goal will be for each participants to achieve 150 min of exercise per week. The one centre‐based session and at least 2 of the home‐based sessions will consist of 10 min of strength exercises, 10 min of balance exercises and 10 min of flexibility exercises. The exercise program will be delivered by at least two qualified exercise physiologists and physiotherapist who is trained in geriatric medicine. The exercise prescription is based on the LIFE study, a physical activity intervention for community‐dwelling frail older people conducted in the USA [Cesari M, Vellas B, Hsu FC, Newman AB, Doss H, King AC, et al. A. J Gerontol A Biol Sci Med Sci. 2015 Feb;70(2):216‐22. ]. The Exercise physiologist will titrate each participants exercise program every 6 weeks to ensure they continue to improve their physical capacity over the 6 month study. Resistant tubing, and/or wrist and/or ankle weights will be used to increase resistance for the strength exercises. Examples of the types of exercises that participants will be asked to do include: 1) WARM UP‐ shoulder/wrist, ankle circles; 2) STRENGTH ‐ knee extension, sit to stand using arms, hip abduction and hip adduction (standing and/or sitting), bicep curl, seated row, heel/toe raise, standing march; 3) Flexibility ‐ arm lift, touching toes. CONDITION: Frailty mild cognitive impairment musculoskeletal PRIMARY OUTCOME: gait speed using 4 m walk test ‐ 2 repetitions grip strength using electronic hand‐held dyanomanometer and dominant hand physical performance using the Standard Physical Performance battery and Timed Up and Go test SECONDARY OUTCOME: Adverse effects will be recorded in a diary. Potential adverse events may include dizziness, chest pain or nausea during or after exercise, or nausea, reduced appetite, and mild gastrointestinal symptoms (e.g. bloating, gas, diarrhoea). Frailty measured using the 5‐item Frail Screen questionnaire Quality of life assessed using the SF 36 questionnaire muscle mass assessed using single frequency bioelectrical impedance nutritional intake assessed using multipass 24 hr diet recall physical activity will be assessed over a 7 day period using accelerometry INCLUSION CRITERIA: ‐ adults aged 65 years and older ‐ able to converse in English ‐ living in the community ‐ have a FRAIL Screen score equal to, or greater than, 1 Strength exercises will be conducted at an intensity of 15‐16 RPE on the Borg Scale and walking will be conducted at an intensity of 12‐14 RPE on the Borg Scale . The Borg Scale allows a rating of the self‐perceived exertion and can be used to monitor and control the intensity of exercise interventions [Pritchett RC, Del Pozzi AT, Katica CP, Pritchett KL. Med Sci Sport Exer. 2011 May;43(5):86]. Instructions on how to perform the home‐based exercises and record the number and intensity of specific exercise will be recorded while at home using a compliance dairy. Compliance diaries will be handed‐out to participants at each assessment visit with instruction on how to complete. Compliance with the required intake of the supplements and exercise prescription will be checked by the research dietitian and exercise physiologist, respectively, on a weekly basis initially (during first two weeks) and every 2 weeks if no problems are evident. If a deviation greater than 10% of the intake recommendations is detected (for either of the supplements) the dietician will interview the participant to identify strategies that could help rectify any reduced compliance and facilitate compliance in case of any difficulty. For the exercise prescription, if a deviation greater than 10% of the required sessions is detected, the exercise physiologist or an supporting team member will interview the participant to identify strategies that could help rectify any reduced compliance and facilitate compliance in case of any difficulty.