The EXPRESS Study: Exercise and Protein Effectiveness Supplementation Study supporting autonomy in community dwelling frail older people-study protocol for a randomized controlled pilot and feasibility study.

Background: Research has repeatedly demonstrated that exercise has a positive impact on physical function and is beneficial in the treatment of physical frailty. However, an even more effective strategy for managing physical frailty might be the combination of multicomponent exercise with the intake of high-quality protein supplements, but the efficacy remains unclear for older adults who are already pre-frail and frail. The aim is to examine the feasibility of recruiting frail older adults to participate in a trial designed to determine the potential effects of a 6-month exercise and nutrition intervention on physical function. The feasibility objectives will include frail older peoples' compliance, the safety and tolerability of the trial, the estimation of estimates to aid sample size calculation, and the potential efficacy. Primary outcomes for the main trial will include gait speed, grip strength and physical performance. Secondary outcomes will include frailty status, muscle mass, nutritional intake, physical activity levels, cognitive performance and quality of life.

Methods/design: A randomised, parallel, control pilot and feasibility study will be conducted. All participants will be randomly assigned to either (a) an exercise program + high-quality protein supplement or (b) an exercise program + low-quality protein supplement. Both protein supplements will be matched closely in colour, flavour and packaging so that both the participants and the research staff are blinded. The exercise program will be the same in both groups. Assessments will be conducted at baseline and at 3 and 6 months and include gait speed, grip strength, the Short Physical Performance Battery, Timed Up and Go Test, FRAIL Screen, bioelectrical impedance analyses, 24-h dietary recall, Katz Activities of Daily Living, Lawton Instrumental Activities of Daily Living, the Trail Making Test, Short Form Health Survey-36, and 1 week accelerometer quantification. The data will be analysed using an ANCOVA model.

Discussion: This study is expected to provide much needed insight into the feasibility of recruiting and retaining frail older adults into community-based intervention programs, while providing knowledge relating to the safety, tolerability and benefits of a combined exercise and protein supplement program designed to halt or reverse the transition of physical frailty in the community. If shown to be effective, this strategy could be included in the best practice clinical guidelines for community-dwelling older adults who are pre-frail or frail.

Trial Registration: Australian New Zealand Clinical Trials Registry, ACTRN12616000521426.