Effect of Micronized Creatine Monohydrate on Muscle Mass, Strength and Performance in Older Adult… (NCT06925880) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Micronized Creatine Monohydrate on Muscle Mass, Strength and Performance in Older Adults Submitted to Total Knee Arthroplasty
Spain262 participantsStarted 2025-06-10
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.