Oral nutritional supplements for older hip fracture patients at nutritional risk (NUTRI-MUSCLES)—a feasibility trial for a two-armed RCT

BACKGROUND: Malnutrition is prevalent in older hip fracture patients and increases the risk of postoperative complications and loss of physical function. Adequate energy and protein intake during rehabilitation can enhance recovery but treatment can be challenging. The primary objective was to assess feasibility, defined as eligibility, recruitment rate, retention in the study, compliance to the intervention and completeness of outcome data collection. METHODS: This single-site, open labelled, parallel, two-arm randomized controlled feasibility trial took place at Orthopaedic Surgical ward at Herlev Hospital, Denmark. Participants were ≥ 65 years at nutritional risk admitted with a hip fracture. The intervention group received two bottles of oral nutritional supplements daily for 12 weeks after discharge. The control group received standard care. RESULTS: Of 134 patients screened, 52 (39%) met inclusion criteria and 21 (40%) were recruited, corresponding to 2.3 participants per week. Preliminary findings showed a retention rate of 16 out of 21 (76%). Compliance to the oral nutritional supplements was 62% reflecting an intake of 1.3 oral nutritional supplementation per day. Data collection was high, with ≥ 80% completeness for most outcomes (handgrip strength, calf circumference, frailty, quality of life, activities of daily living, 24-h recall, blood measures), except for the baseline 30-s chair-stand test. CONCLUSION: The trial methods were feasible with sufficient eligibility, recruitment rate, retention in the study and outcome data collection. Compliance was lower than expected highlighting the need for strategies to improve adherence in the definitive trial. TRIALS REGISTRATION: ClinicalTrials.gov identifier: NCT05556876. Date of registration: 2022.23.09. URL: https://clinicaltrials.gov/study/NCT05556876 .