A single-blind, placebo controlled, randomized trial to evaluate the efficacy of protein fortified food in rehabilitation patients

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2015
INTERVENTION: Protein(10g/pack) and Vitamin D(20ug/pack) fortified food (2pack/day, 16weeks) Placebo(Protein 0g, Vitamin D 0ug) food (2pack/day, 16weeks) CONDITION: Patients in recovery phase rehabilitation hospital PRIMARY OUTCOME: Skeletal muscle mass (BIA, thigh muscle area by Computed tomography) after 16 weeks intervention SECONDARY OUTCOME: Muscle strength (handgrip, lower limb), ADL (FIM, mBI), Physical activity (walking test, timed up & go test, chair‐stand test), Nutritional index(alb, pre‐Alb, IGF‐1, DHEA‐s, free‐teststerone, 25(OH)D, PTH, Ca), length of hospital stay, discharge disposition (home/not home) INCLUSION CRITERIA: 1. Aged 40 or older 2. FIM locomotion subscore is 4 or less, social interaction subscore is 6 or over and comprehension and expression is 5 or over 3. Within two weeks after admission 4. Patients who can ride normal wheelchair
Epistemonikos ID: 4b671484ef60883be783e8de7ca45f84d0b71006
First added on: Aug 23, 2024