Double-blind randomized placebo-controlled clinical trial with two parallel arms. The main objective is to evaluate the efficacy and safety of creatine supplementation in older adults who have been operated on for total knee arthroplasty and undergoing a usual rehabilitation program. The intervention will consist of daily creatine monohydrate supplementation for 12 weeks. The intervention will start after surgery with a loading dose of 20g/day for 1 week and then continue with a maintenance dose of 5g/day for 11 weeks.
Main outcome mesures included muscle mass, muscle strenght, sarcopenia, frailty, functional capacity and physical performance and will be assessed at baseline, 3 and 6 months follow-up.
Persons 65 years of age or older who have been operated on for the first time for total knee arthroplasty,
who are undergoing an outpatient rehabilitation program according to standard clinical practice,
who sign the informed consent form.
Chronic renal disease at stage G3b or higher or glomerular filtration rate <30 ml/min/1.73m2.
Hepatic insufficiency, cirrhosis.
Neuromuscular and neurodegenerative diseases (amyotrophic lateral sclerosis, multiple sclerosis, muscular dystrophy, myasthenia gravis, Parkinson's disease, etc.).
Severe or very severe chronic obstructive pulmonary disease (COPD) (GOLD III-IV).
Parallel
Creatine Monohydrate
Dietary supplementThe intervention will consist of daily supplementation with micronized creatine monohydrate (FullGas Sport Creatine 200 mesh) for 12 weeks. The intervention will start at the time of hospital discharge with a loading dose of 20g/day for 1 week, divided into 4 intakes of 5g to favor digestive tolerance (breakfast, lunch, snack and dinner). Subsequently, a maintenance dose of 5g/day will be continued for 11 weeks (breakfast). Creatine should be consumed with food to improve its absorption.
Placebo
Other interventionThe control group will follow the same rehabilitation regimen as the intervention group and will receive a placebo with FullGas Sport microcrystalline cellulose. Its physical and organoleptic characteristics are the same as micronized creatine monohydrate. The dosage will be the same as that indicated for the study intervention: it will start at the time of hospital discharge with a loading dose of 20g/day for 1 week, divided into 4 intakes of 5g to favor digestive tolerance (breakfast, lunch, snack and dinner). Subsequently, a maintenance dose of 5g/day will be continued for 11 weeks (breakfast).
Change in muscle mass
Mesured by Bioimpedance Analysis
Change in Muscle Strenght
Handgrip mesured by Jamar Dynamometer
Change in the prevalence of Sarcopenia
Mesured by EWGSOP2 criteria
Change in Functional Capacity
Mesured by Barthel score
Change in Frailty status
Mesured by Linda Fried criteria (0 positive criteria: robust, 1-2: pre-frail positive criteria, 3 or more positive criteria: frail)
Arthroscopy complications
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Consorci Sanitari del Maresme
Lead sponsor
Fundació Privada Salut del Consorci Sanitari del Maresme
Collaborator
