Actively Recruiting
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
Led by Consorci Sanitari del Maresme · Updated on 2026-03-30
262
Participants Needed
1
Research Sites
21 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
Researchers are evaluating the effects of micronized creatine monohydrate supplementation on muscle mass, strength, sarcopenia, frailty, functional capacity, and physical performance in older adults who have undergone total knee arthroplasty. This randomized, double-blind, placebo-controlled trial aims to assess the efficacy and safety of creatine supplementation alongside a usual rehabilitation program. The study is led by Consorci Sanitari del Maresme and focuses on adults aged 65 and older. Participants will be randomly assigned to one of two groups: an intervention group receiving creatine monohydrate and a control group receiving a placebo. Both groups will start supplementation at hospital discharge with a loading dose of 20g per day for 1 week, divided into four intakes to aid digestion. This will be followed by a maintenance dose of 5g per day for 11 weeks, taken with food to improve absorption. Both groups will follow the same rehabilitation program. During the study, researchers will assess muscle mass, muscle strength, sarcopenia prevalence, functional capacity, physical performance, aerobic capacity, walking speed, and adverse health events at baseline, 3 months, and 6 months follow-up. They will also monitor frailty status and arthroscopy complications. Participants will be involved in regular evaluations over the 6-month period to track changes and safety outcomes related to the supplementation.
CONDITIONS
Brief Title
Effect of Micronized Creatine Monohydrate on Muscle Mass, Strength and Performance in Older Adults Submitted to Total Knee Arthroplasty
Who Can Participate
Eligibility Criteria
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
- Undergoing an outpatient rehabilitation program according to standard clinical practice
- Signed the informed consent form
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)
- Moderate to severe dependence for basic activities of daily living (preintervention Barthel index less than 60 points)
- Hemiparesis, amputation, or malformation of any limb
- Consumption of creatine monohydrate supplements in the last 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive daily supplementation with micronized creatine monohydrate or placebo starting at hospital discharge. This includes a 1-week loading dose followed by 11 weeks of maintenance dosing.
1 baseline visit and multiple follow-up visits at 3 and 6 months
Trial Site Locations
Total: 1 location
1
Elisabet Palomera
Mataró, Barcelona, Spain, 08304
Actively Recruiting
Research Team
J
Jéssica Martínez Rodríguez
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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