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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06925880

Acronym

CREAR

Enrollment

262

Registered

2025-04-13

Start date

2025-06-10

Completion date

2027-10-31

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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 criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Change in muscle mass	Baseline, 3 and 6 months follow-up	Mesured by Bioimpedance Analysis
Change in Muscle Strenght	Baseline, 3 and 6 months follow-up	Handgrip mesured by Jamar Dynamometer
Change in the prevalence of Sarcopenia	Baseline, 3 and 6 months follow-up	Mesured by EWGSOP2 criteria
Change in Functional Capacity	Baseline, 3 and 6 months follow-up	Mesured by Barthel score
Changes in Performance	Baseline, 3 and 6 months follow-up	Mesured by Timed Up and Go Test (seconds)
Changes in Physical Performance	Baseline, 3 and 6 months follow-up	Mesured by Short Physical Performance Batery (SPPB)
Changes in aerobic capacity	Baseline, 3 and 6 months follow-up	Mesured by 6 minutes Walking Test (meters)
Changes in Walking Speed	Baseline, 3 and 6 months follow-up	Mesured by Gaid Speed
Number of Advers Health Events	Baseline, 3 and 6 months follow-up	Register of advers health events

Secondary

Measure	Time frame	Description
Change in Frailty status	Baseline, 3 and 6 months follow-up	Mesured by Linda Fried criteria (0 positive criteria: robust, 1-2: pre-frail positive criteria, 3 or more positive criteria: frail)
Arthroscopy complications	Baseline, 3 and 6 months follow-up	—

Countries

Spain

Contacts

CONTACTJéssica Martínez Rodríguez

jmartinezro@csdm.cat0034 937417700

PRINCIPAL_INVESTIGATORJéssica Martínez Rodríguez

Consorci Sanitari del Maresme

STUDY_DIRECTORMateu Serra-Prat, PhD