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Effects of a primary care-based multifactorial intervention on physical and cognitive function in frail, elderly individuals: a randomized controlled trial
Romera-Liebana L, Orfila F, Segura JM, Real J, Fabra ML, Moller M, Lancho S, Ramirez A, Marti N, Cullell M, Bastida N, Martinez D, Gine M, Cendros P, Bistuer A, Perez E, Fabregat MA, Foz G
The Journals of Gerontology. Series A, Biological Sciences and Medical Sciences 2018 Dec;73(12):1688-1674
clinical trial
7/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Detecting and managing frailty at early stages can prevent disability and other adverse outcomes. The study aim was to evaluate whether a multifactorial intervention program could modify physical and cognitive frailty parameters in elderly individuals. METHODS: We conducted a multicenter, randomized, single-blind, parallel-group trial in community-living prefrail/frail elderly individuals in Barcelona. A total of 352 patients, aged >= 65 years old with positive frailty screening, was randomized into two groups to receive a 12-week multidisciplinary intervention or usual care, with concealed allocation. The intervention consisted of: exercise training, intake of hyperproteic nutritional shakes, memory training, and medication review. Main outcome assessments with multivariate analysis were conducted at 3 and 18 months. RESULTS: A total of 347 participants (98.6%) completed the study, mean age 77.3 years, 89 prefrail subjects (25.3%), and 75.3% female (n = 265). Eighteen-month assessments were performed in 76% of the sample. After 3 and 18 months, adjusted means difference between-groups showed significant improvements for the intervention group in all comparisons: Short Physical Performance Battery score improved 1.58 and 1.36 points (p < 0.001), handgrip strength 2.84 and 2.49 kg (p < 0.001), functional reach 4.3 and 4.52 cm (p < 0.001), and number of prescriptions decreased 1.39 and 1.09 (p < 0.001), respectively. Neurocognitive battery also showed significant improvements across all dimensions at 3 and 18 months. CONCLUSIONS: A physical, nutritional, neurocognitive, and pharmacological multifaceted intervention was effective in reversing frailty measures both at short-term and 18 months. Lasting benefits of a multi-intervention program among frail elderly individuals encourage its prioritization.
Copyright the Gerontological Society of America. Reproduced by permission of the publisher.

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