Abstract
Abstract Background There is a need for effective primary-care interventions that help older people combat frailty and build resilience. This study aims to test the effectiveness of a co-designed exercise and dietary protein intervention. Methods This was a multicentre, randomised-controlled, parallel-arm trial in six Irish primary-care practices. We enrolled adults aged 65+ with Clinical Frailty Scale score ≤5 from December 2020 to April 2021. Participants were randomised to intervention or usual care with allocation concealed until enrolment with a GP. Intervention comprised exercises, emphasising strength, and dietary protein guidance. At three-month follow-up, effectiveness was measured by comparing SHARE-Frailty Instrument between groups, on intention-to-treat basis. Secondary outcomes included muscle mass, bone mass and biological age measured by Bioelectrical Impedance Analysis (BIA). Ease of intervention and health difference were measured on Likert scales. Results 359 adults were assessed for eligibility and 168 enrolled. 156 (92.9%) attended follow-up (mean age 77.1; 67.3% women; 79 intervention, 77 control). At baseline, frailty proportions were 17.7% in the intervention and 16.9% in the control group. At follow-up, they were 6.3% and 18.2%, respectively. The odds ratio (OR) of being frail for the intervention group was 0.23 times that of the control group (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%; P=0.018). Number needed to treat was 8.4. BIA parameters improved, bone mass significantly (P=0.040). 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. Frailty was reversed in more than 1 in 9 participants.
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