RecruitingNot ApplicableNCT06925880

Effect of Micronized Creatine Monohydrate on Muscle Mass, Strength and Performance in Older Adults Submitted to Total Knee Arthroplasty

Efficacy of Supplementation With Micronized Creatine Monohydrate in the Recovery of Muscle Mass, Muscle Strength and Functional Capacity in Older Adults Operated on for Total Knee Arthroplasty: Randomized Clinical Trial

Sponsor

Consorci Sanitari del Maresme

Enrollment

262 participants

Start Date

Jun 10, 2025

Study Type

INTERVENTIONAL

Conditions

Physical Performance Frailty at Older Adults Functional Capacity Sarcopenia in Elderly Arthroplasties, Knee Replacement Creatine Supplementation

Summary

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.

Eligibility

Min Age: 65 Years

Inclusion Criteria3

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.

Exclusion Criteria10

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).
Moderate or severe chronic heart failure (NYHA 3-4).
Central sensitivity syndrome (fibromyalgia and chronic fatigue syndrome).
Moderate or severe cognitive impairment (GDS≥4).
Moderate-severe dependence for basic activities of daily living (preintervention Barthel index \<60 points).
Hemiparesis, amputation or malformation of any limb.
Consumption of creatine monohydrate supplements in the last 6 months.

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Interventions

DIETARY_SUPPLEMENTCreatine Monohydrate

The 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.

OTHERPlacebo

The 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).