Effect of Micronized Creatine Monohydrate on Muscle Mass, Strength and Performance in Older Adults Submitted to Total Knee Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Creatine Monohydrate, Placebo.
- Who it may be relevant to
- Registry conditions: Sarcopenia in Elderly, Frailty at Older Adults, Functional Capacity, Creatine Supplementation. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Dietary supplement Creatine Monohydrate
The intervention will consist of daily supplementation with micronized creatine monohydrate (FullGas Sport Creatine 200 mesh) for 12 weeks. The intervention will start at the time of hospital discharge with a loading dose of 20g/day for 1 week, divided into 4 intakes of 5g to favor digestive tolerance (breakfast, lunch, snack and dinner). Subsequently, a maintenance dose of 5g/day will be continued for 11 weeks (breakfast). Creatine should be consumed with food to improve its absorption. - Other Placebo
The control group will follow the same rehabilitation regimen as the intervention group and will receive a placebo with FullGas Sport microcrystalline cellulose. Its physical and organoleptic characteristics are the same as micronized creatine monohydrate. The dosage will be the same as that indicated for the study intervention: it will start at the time of hospital discharge with a loading dose of 20g/day for 1 week, divided into 4 intakes of 5g to favor digestive tolerance (breakfast, lunch, s
Primary outcome measures
- Change in muscle mass [Time frame: Baseline, 3 and 6 months follow-up]
- Change in Muscle Strenght [Time frame: Baseline, 3 and 6 months follow-up]
- Change in the prevalence of Sarcopenia [Time frame: Baseline, 3 and 6 months follow-up]
- Change in Functional Capacity [Time frame: Baseline, 3 and 6 months follow-up]
- Changes in Performance [Time frame: Baseline, 3 and 6 months follow-up]
- Changes in Physical Performance [Time frame: Baseline, 3 and 6 months follow-up]
- Changes in aerobic capacity [Time frame: Baseline, 3 and 6 months follow-up]
- Changes in Walking Speed [Time frame: Baseline, 3 and 6 months follow-up]
- Number of Advers Health Events [Time frame: Baseline, 3 and 6 months follow-up]
Secondary outcome measures (2)
- Change in Frailty status [Time frame: Baseline, 3 and 6 months follow-up]
- Arthroscopy complications [Time frame: 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Elisabet Palomera — Mataró
Identifiers
NCT: NCT06925880 · CEIm CSdM 24/25