Effect, process, and economic evaluation of a combined resistance exercise and diet intervention (ProMuscle in Practice) for community-dwelling older adults : Design and methods of a randomised controlled trial

Dongen, Ellen J.I. van; Haveman-Nies, Annemien; Wezenbeek, Nick L.W.; Dorhout, Berber G.; Doets, Esmée L.; Groot, Lisette C.P.G.M. De


Background: Exercise and nutrition are important for older adults to maintain or to regain their muscle mass, function, strength, and ultimately quality of life. The effectiveness of combined resistance exercise and diet interventions is commonly evaluated in controlled clinical studies, but evidence from real-life settings is lacking. This article describes the effectiveness, process, and economic evaluation design of a combined nutrition and exercise intervention for community-dwelling older adults in a Dutch real-life setting. Methods: The ProMuscle in Practice study is a randomised controlled multicentre intervention study, conducted in five municipalities in the Netherlands. Two hundred community-dwelling older adults (≥65 years) who are frail or pre-frail based on Fried frailty criteria or who experience strength loss are randomised over an intervention and control group by municipality. In the first 12-week intensive support intervention, participants in the intervention group perform resistance exercise training guided by a physiotherapist twice a week and increase protein intake by consuming protein-rich products under the supervision of a dietitian. Afterwards, they continue with a 12-week moderate support intervention. The control group receives only regular care during the two 12-week periods. Effect outcomes are measured at all locations at baseline, 12 weeks, 24 weeks, 36 weeks and only at three locations at 52 weeks. The primary outcome is physical functioning (Short Physical Performance Battery). Secondary outcomes include leg muscle strength, lean body mass, activities of daily living, social participation, food intake, and quality of life. Qualitative and quantitative implementation process data are collected during the intervention. Healthcare use and intervention costs are registered for the economic evaluation. Discussion: Evaluating the effects, implementation, and costs of this combined intervention provides valuable insight into the feasibility of this intervention for community-dwelling older adults and into the intervention's ability to improve or to maintain physical functioning and quality of life. Trial registration: Netherlands Trial Register (NTR6038) since 30 August 2016.