Individualised physical exercise training and enhanced protein intake in older citizens during municipality-based rehabilitation: protocol for a randomised controlled trial.

Introduction: Successful rehabilitation of the growing number of older citizens receiving healthcare services can lead to preservation of functional independence and improvement in quality of life. Adequate intake of dietary protein and physical training are key factors in counteracting the age-related decline in strength performance and physical function. However, during rehabilitation, many older people/persons have insufficient protein intake, and difficulties in performing exercise training with sufficient intensity and volume. The primary aim of this trial is to investigate if individualised physical exercise training programmes combined with increased protein intake (IPET+P) can improve measures on all International Classification of Functioning, Disability and Health levels, such as strength, gait speed and health-related quality of life, when compared with care as usual in municipality-based rehabilitation alone (usual care, UC) or care as usual in combination with increased protein intake (UC+P). Further, the trial investigates whether UC+P will potentiate more significant improvements in outcome measures than UC.

Methods And Analysis: The trial is a three-armed multicentre, block-randomised controlled trial consisting of a 12-week intervention period with a 1-year follow-up. Citizens above 65 years referred to rehabilitation in the municipality without restricting comorbidities are eligible. Participants are randomised to either a UC group, a UC group with protein supplementation receiving 27.5 g protein/day (UC+P), or an IPET+P supplementation of 27.5 g protein/day. The Short Musculoskeletal Function Assessment questionnaire is the primary outcome.

Ethics And Dissemination: Approvals from The Ethics Committee in Region Zealand, Denmark (SJ-758 and the General Data Protection Regulation at the University of Southern Denmark, Odense (10.330) have been obtained.

Trial Registration Number: NCT04091308.