Effect of Micronized Creatine Monohydrate on Muscle Mass, Strength and Performance in Older Adults Submitted to Total Knee Arthroplasty (CREAR)

Consorci Sanitari del Maresme

Status: Not yet enrolling

Conditions: Physical Performance; Functional Capacity; Creatine Supplementation; Sarcopenia in Elderly; Arthroplasties, Knee Replacement; Frailty at Older Adults

Treatments: Other: Placebo; Dietary Supplement: Creatine Monohydrate

Study type: Interventional

Funder types: Other

Identifiers

NCT06925880

CEIm CSdM 24/25

Details and patient eligibility

About

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.

Enrollment: 262 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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262 participants in 2 patient groups, including a placebo group

CREATINE

Experimental group

Description:

The intervention will consist of daily supplementation with micronized creatine monohydrate for 12 weeks. The intervention will start at the time of hospital discharge with a loading dose of 20g/day for 1 week. Subsequently, a maintenance dose of 5g/day will be continued for 11 weeks.

Treatment:

Dietary Supplement: Creatine Monohydrate

PLACEBO

Placebo Comparator group

Description:

The control group will follow the same rehabilitation regimen as the intervention group and will receive a placebo. It will start at the time of hospital discharge with a loading dose of 20g/day for 1 week. Subsequently, a maintenance dose of 5g/day will be continued for 11 weeks.

Treatment:

Other: Placebo