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Abstract
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
- sports medicine
- nutrition & dietetics
- geriatric medicine
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Footnotes
Contributors All authors have been involved in forming the detailed project description. ST and LH prepared the grant applications. ST, KS, TD, LFS, NON and LH elaborated on the trial protocol. GS and TD contributed to the design of individualised physical exercise training. ST wrote the first draft and is the guarantor of the manuscript; all authors contributed and have approved the final version. None of the sponsors were involved in the trial design and will not be a part of the collection, management, analysis, and interpretation of data.
Funding This trial (case number 8045-00052B) has been reviewed by The Danish Council for Independent Research (IRFD) and Research Committee for Physiotherapists (RCP). The project has been granted 2.589.134 DKK (incl. 44 % overhead) from IRFD, 290.000 DKK from RCP, and 373.026 DKK from University College Absalon. The total budget for this project is 3.252.160 DKK. Furthermore, Arla AMBA will sponsor 21.240 bottles of protein-enriched yoghurts for the entire trial, the retail price of which is approximately 212.000 DKK.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.