NCT06925880 Effect of Micronized Creatine Monohydrate on Muscle Mass, Strength and Performance in Older Adults Submitted to Total Knee Arthroplasty
| NCT ID | NCT06925880 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Consorci Sanitari del Maresme |
| Condition | Sarcopenia in Elderly |
| Study Type | INTERVENTIONAL |
| Enrollment | 262 participants |
| Start Date | 2025-06-10 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 262 participants in total. It began in 2025-06-10 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Jéssica Martínez Rodríguez
PRINCIPAL INVESTIGATOR
Consorci Sanitari del Maresme
Frequently Asked Questions
Who can join the NCT06925880 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Sarcopenia in Elderly. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06925880 currently recruiting?
Yes, NCT06925880 is actively recruiting participants. Contact the research team at jmartinezro@csdm.cat for enrollment information.
Where is the NCT06925880 trial being conducted?
This trial is being conducted at Mataró, Spain.
Who is sponsoring the NCT06925880 clinical trial?
NCT06925880 is sponsored by Consorci Sanitari del Maresme. The principal investigator is Jéssica Martínez Rodríguez at Consorci Sanitari del Maresme. The trial plans to enroll 262 participants.