RecruitingPhase 3ACTRN12616000521426

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

Sponsor

University of Adelaide

Enrollment

120 participants

Start Date

Aug 9, 2016

Study Type

Interventional

Conditions

Frailty

Summary

This proposed research will examine the feasibility of the FRAIL Screen in general practice as a screening tool for frailty and determine the impact of a high- as compared to low-quality protein supplement in combination with a centre- and home-based exercise intervention on muscle strength, physical function parameter and quality of life in frail older people who live in the community. Aims: 1. To examine, the feasibility of recruiting 120 community-dwelling older people, aged 65 years and older who have screened frail (>1) using the FRAIL SCREEN tool to a 6 months intervention study involving nutrition and exercise; 2. To determine the effects, over a period of 6 months, of exercise in combination with either (i) high-quality whey protein supplements or (ii) lower-quality rice protein supplement, on the primary outcomes of gait speed, leg press and grip strength, and physical performance, and other secondary outcomes including frailty, muscle mass, nutritional intake, physical activity, and quality of life. Hypotheses: 1. It is feasible to recruit 120 community dwelling frail older people using the FRAIL SCREEN tool through the ACH referral system and multiple proposed referral strategies. 2. It is feasible for participants to participate in the proposed nutritional and exercise supplementation program for a period of 6 months. 3. The higher-quality whey protein supplement combined with a pragmatic exercise program will result in greater improvement of gait speed and grip strength, physical performance and quality of life, and the other secondary outcomes at 3 months and 6 months than a lower quality rice protein combined with pragmatic exercise program, in older people who are frail or at-risk of frailty as determined by the FRAIL Screen.

Eligibility

Sex: Both males and femalesMin Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining regular exercise with a high-quality whey protein supplement — compared to a lower-quality rice protein supplement — helps older adults who are frail or at risk of becoming frail to get stronger, move better, and live more independently. Frailty is a condition where people become weaker and more vulnerable as they age, making everyday tasks difficult. Both groups will exercise and take protein supplements for 6 months. You may be eligible if: - You are 65 years or older - You live in the community (not in a care home) - You score 1 or higher on the FRAIL Screen tool (indicating some frailty) - You can communicate in English You may NOT be eligible if: - You have significant memory problems or dementia - You have severe kidney disease (eGFR below 30) - You are unable to safely participate in the exercise or nutrition program Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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. 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.