Status:
NOT_YET_RECRUITING
Effect of Micronized Creatine Monohydrate on Muscle Mass, Strength and Performance in Older Adults Submitted to Total Knee Arthroplasty
Lead Sponsor:
Consorci Sanitari del Maresme
Collaborating Sponsors:
Fundació Privada Salut del Consorci Sanitari del Maresme
Conditions:
Sarcopenia in Elderly
Frailty at Older Adults
Eligibility:
All Genders
65+ years
Phase:
NA
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 op...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT06925880
Start Date
April 22 2025
End Date
October 31 2026
Last Update
April 13 2025
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