Clinical trial NCT06925880: Effect of Micronized Creatine Monohydrate on Muscle Mass, Strength and Performance in Older Adults Submitted to Total Knee Arthroplasty
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sarcopenia in Elderly
Frailty at Older Adults
Functional Capacity
Creatine Supplementation
Arthroplasties, Knee Replacement
Physical Performance
Lead sponsor: Consorci Sanitari del Maresme
Sponsor class: OTHER
Collaborators: name: Fundació Privada Salut del Consorci Sanitari del Maresme
First posted: 2025-04-13
Enrollment: 262
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Change in muscle mass
timeFrame: Baseline, 3 and 6 months follow-up
measure: Change in Muscle Strenght
timeFrame: Baseline, 3 and 6 months follow-up
measure: Change in the prevalence of Sarcopenia
timeFrame: Baseline, 3 and 6 months follow-up
measure: Change in Functional Capacity
timeFrame: Baseline, 3 and 6 months follow-up
measure: Changes in Performance
timeFrame: Baseline, 3 and 6 months follow-up
measure: Changes in Physical Performance
timeFrame: Baseline, 3 and 6 months follow-up
measure: Changes in aerobic capacity
timeFrame: Baseline, 3 and 6 months follow-up
measure: Changes in Walking Speed
timeFrame: Baseline, 3 and 6 months follow-up
measure: Number of Advers Health Events
timeFrame: Baseline, 3 and 6 months follow-up
Secondary outcomes:
measure: Change in Frailty status
timeFrame: Baseline, 3 and 6 months follow-up
measure: Arthroscopy complications
timeFrame: Baseline, 3 and 6 months follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Consorci Sanitari del Maresme
name: Jéssica Martínez Rodríguez
role: PRINCIPAL_INVESTIGATOR
affiliation: Consorci Sanitari del Maresme
name: Mateu Serra-Prat, PhD
role: STUDY_DIRECTOR
References: