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

NCT06925880 | Recruiting

• 1 other identifier: CEIm CSdM 24/25
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (9)

• Change in muscle mass

  Mesured by Bioimpedance Analysis

  Baseline, 3 and 6 months follow-up

• Change in Muscle Strenght

  Handgrip mesured by Jamar Dynamometer

  Baseline, 3 and 6 months follow-up

• Change in the prevalence of Sarcopenia

  Mesured by EWGSOP2 criteria

  Baseline, 3 and 6 months follow-up

• Change in Functional Capacity

  Mesured by Barthel score

  Baseline, 3 and 6 months follow-up

• Changes in Performance

  Mesured by Timed Up and Go Test (seconds)

  Baseline, 3 and 6 months follow-up

• Changes in Physical Performance

  Mesured by Short Physical Performance Batery (SPPB)

  Baseline, 3 and 6 months follow-up

• Changes in aerobic capacity

  Mesured by 6 minutes Walking Test (meters)

  Baseline, 3 and 6 months follow-up

• Changes in Walking Speed

  Mesured by Gaid Speed

  Baseline, 3 and 6 months follow-up

• Number of Advers Health Events

  Register of advers health events

  Baseline, 3 and 6 months follow-up

Secondary Outcomes (2)

• Change in Frailty status

  Baseline, 3 and 6 months follow-up

• Arthroscopy complications

  Baseline, 3 and 6 months follow-up

Study Arms (2)

CREATINE

EXPERIMENTAL

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.

Dietary Supplement: Creatine Monohydrate

PLACEBO

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Creatine Monohydrate 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.

CREATINE

Placebo 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).

PLACEBO

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorci Sanitari del Maresme: lead
• Fundació Privada Salut del Consorci Sanitari del Maresme: collaborator

Study Sites (1)

Elisabet Palomera

Mataró, Barcelona, 08304, Spain

RECRUITING

MeSH Terms

Interventions

Creatine

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Jéssica Martínez Rodríguez

  Consorci Sanitari del Maresme

  PRINCIPAL INVESTIGATOR

• Mateu Serra-Prat, PhD

  Consorci Sanitari del Maresme

  STUDY DIRECTOR

Central Study Contacts

Jéssica Martínez Rodríguez

CONTACT

0034 937417700; jmartinezro@csdm.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 13, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)