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

NCT ID: NCT06925880

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-22
• Study Completion Date: 2026-10-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CREATINE

The intervention will consist of daily supplementation with micronized creatine monohydrate for 12 weeks. The intervention will start at the time of hospital discharge with a loading dose of 20g/day for 1 week. Subsequently, a maintenance dose of 5g/day will be continued for 11 weeks.

Group Type: EXPERIMENTAL

Creatine Monohydrate

Intervention Type: DIETARY_SUPPLEMENT

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.

PLACEBO

The control group will follow the same rehabilitation regimen as the intervention group and will receive a placebo. It will start at the time of hospital discharge with a loading dose of 20g/day for 1 week. Subsequently, a maintenance dose of 5g/day will be continued for 11 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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).

Interventions

Creatine 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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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).

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundació Privada Salut del Consorci Sanitari del Maresme

UNKNOWN

Sponsor Role: collaborator

Consorci Sanitari del Maresme

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jéssica Martínez Rodríguez

Role: PRINCIPAL_INVESTIGATOR

Consorci Sanitari del Maresme

Mateu Serra-Prat, PhD

Role: STUDY_DIRECTOR

Consorci Sanitari del Maresme

Central Contacts

Jéssica Martínez Rodríguez

Role: CONTACT

jmartinezro@csdm.cat

0034 937417700 ext. 2282

Other Identifiers

CEIm CSdM 24/25

Identifier Type: -

Identifier Source: org_study_id