Building resilience and reversing frailty: a randomised controlled trial of a primary care intervention for older adults.

BACKGROUND: There is a need for effective primary care interventions that help older people combat frailty and build resilience. OBJECTIVE: To study the effectiveness of an optimised exercise and dietary protein intervention. DESIGN: Multicentre, randomised-controlled, parallel-arm trial. SETTING: Six primary care practices, Ireland. METHODS: Six general practitioners enrolled adults aged 65+ with Clinical Frailty Scale score ≤5 from December 2020 to May 2021. Participants were randomised to intervention or usual care with allocation concealed until enrolment. Intervention comprised a 3-month home-based exercise regime, emphasising strength, and dietary protein guidance (1.2 g/kg/day). Effectiveness was measured by comparing frailty levels, based on the SHARE-Frailty Instrument, on an intention-to-treat basis. Secondary outcomes included bone mass, muscle mass and biological age measured by bioelectrical impedance analysis. Ease of intervention and perceived health benefit were measured on Likert scales. RESULTS: Of the 359 adults screened, 197 were eligible and 168 enrolled; 156 (92.9%) attended follow-up (mean age 77.1; 67.3% women; 79 intervention, 77 control). At baseline, 17.7% of intervention and 16.9% of control participants were frail by SHARE-FI. At follow-up, 6.3 and 18.2% were frail, respectively. The odds ratio of being frail between intervention and control groups post-intervention was 0.23 (95% confidence interval: 0.07-0.72; P = 0.011), adjusting for age, gender and site. Absolute risk reduction was 11.9% (CI: 0.8%-22.9%). Number needed to treat was 8.4. Grip strength (P < 0.001) and bone mass (P = 0.040) improved significantly. 66.2% found the intervention easy, 69.0% reported feeling better. CONCLUSION: A combination of exercises and dietary protein significantly reduced frailty and improved self-reported health.

Protocol for a randomised controlled trial of a primary care intervention to Reverse Frailty and Enhance Resilience through Exercise and dietary protein Education (REFEREE) in community-dwelling adults aged 65 and over.

Introduction: Resistance exercises and dietary protein have been shown to reverse frailty, yet they are not commonly offered in clinical practice. We aim to measure changes in health outcomes, including physical frailty status (SHARE-FI), clinical frailty status (CFS) and muscle mass, as a result of an optimised exercise and dietary intervention versus usual care in a primary care (PC) setting. The intervention has been derived from our systematic review and meta-analysis findings and optimised through patient and public involvement and multidisciplinary team input. Methods: This study is a multicentre randomised controlled parallel arm trial with a three month follow up. 210 eligible people aged 65 and over, no more than mildly frail, will be recruited in seven PC practices in Ireland and randomly assigned to 'intervention' or 'usual care'. Intervention participants will be provided a leaflet with strength exercises, protein dietary guidance and educational discussion. Baseline measurements will include demographics, health indicators, comorbidities, malnutrition universal screening tool (MUST), frailty status (SHARE-FI, CFS) and muscle mass (bioelectrical impedance). Primary outcome will be frailty status measured by SHARE-FI at three months. Secondary outcomes include CFS, muscle mass, in-patient hospitalisation, long term care admission, and subjective ease of intervention and difference to general health. Statistical analysis will be undertaken by an independent statistician. Discussion: The diversity of tested frailty interventions and lack of clear guidance may contribute to low implementation rates. The REFEREE trial focusses on an optimised intervention for a syndrome that poses growing individual and societal challenges. It is hoped results can encourage mainstream adoption of interventions to reverse clinical frailty and build resilience in primary care. Trial registration: ClinicalTrials.gov ID NCT04628754; registered on 13 November 2020.

Femoral offset found not to affect metal ion levels in metal-on-metal total hip arthroplasty.

BACKGROUND: Failure to restore femoral offset in metal on polyethylene total hip arthroplasty (THA) causes polyethylene wear and aseptic loosening. To our knowledge, no study to date has investigated the relationship between femoral offset and wear in metal-on-metal (MOM) THA. AIMS: In this study, we investigated the relationship between femoral offset and wear by measuring circulating metal ion levels in MOM THA. METHODS: In this retrospective study, we identified patients who had undergone MOM THA with the ASR XL system (DePuy International Ltd., Leeds, UK). Femoral offset was measured using anteroposterior radiographs, and circulating metal ion levels (cobalt and chromium) were recorded. RESULTS: In total, 95 patients were included (68 males and 27 females). The mean age at the time of surgery was 64.9. Mean time from surgery to blood sampling was 15.4 months. No statistically significant relationship was found between femoral offset and cobalt (p = 0.313) or chromium (p = 0.401) ions. CONCLUSION: It is known that failure to restore femoral offset during THA can lead to high rates of wear in metal-on-polyethylene articulations. In our study, no statistically significant relationship was found between femoral offset and serum cobalt or chromium ions. This study adds to the information available to surgeons regarding factors that increase wear in metal-on-metal total hip arthroplasty.