Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
NCT06925880

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

Led by Consorci Sanitari del Maresme · Updated on 2026-03-30

262

Participants Needed

1

Research Sites

124 weeks

Total Duration

On this page

Sponsors

C

Consorci Sanitari del Maresme

Lead Sponsor

F

Fundació Privada Salut del Consorci Sanitari del Maresme

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Persons 65 years of age or older who have been operated on for the first time for total knee arthroplasty
  • Currently undergoing an outpatient rehabilitation program according to standard clinical practice
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Chronic renal disease at stage G3b or higher or glomerular filtration rate less than 30 ml/min/1.73m2
  • Hepatic insufficiency or cirrhosis
  • Neuromuscular and neurodegenerative diseases such as amyotrophic lateral sclerosis, multiple sclerosis, muscular dystrophy, myasthenia gravis, Parkinson's disease
  • Severe or very severe chronic obstructive pulmonary disease (COPD) GOLD III-IV
  • Moderate or severe chronic heart failure (NYHA 3-4)
  • Central sensitivity syndrome including fibromyalgia and chronic fatigue syndrome
  • Moderate or severe cognitive impairment (GDS 4 or higher)
  • Moderate to severe dependence for basic daily activities (Barthel index less than 60 points)
  • Hemiparesis, amputation, or malformation of any limb
  • Use of creatine monohydrate supplements in the last 6 months

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Elisabet Palomera

Mataró, Barcelona, Spain, 08304

Actively Recruiting

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Research Team

J

Jéssica Martínez Rodríguez

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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