Elisabet Palomera
Mataró, Barcelona, 08304, Spain
Location status: Recruiting
NCT Number: NCT06925880
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Mataró, Barcelona, 08304, Spain
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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, snack and dinner). Subsequently, a maintenance dose of 5g/day will be continued for 11 weeks (breakfast).
Time frame: Baseline, 3 and 6 months follow-up
Mesured by Bioimpedance Analysis
Time frame: Baseline, 3 and 6 months follow-up
Handgrip mesured by Jamar Dynamometer
Time frame: Baseline, 3 and 6 months follow-up
Mesured by EWGSOP2 criteria
Time frame: Baseline, 3 and 6 months follow-up
Mesured by Barthel score
Time frame: Baseline, 3 and 6 months follow-up
Mesured by Timed Up and Go Test (seconds)
Time frame: Baseline, 3 and 6 months follow-up
Mesured by Short Physical Performance Batery (SPPB)
Time frame: Baseline, 3 and 6 months follow-up
Mesured by 6 minutes Walking Test (meters)
Time frame: Baseline, 3 and 6 months follow-up
Mesured by Gaid Speed
Time frame: Baseline, 3 and 6 months follow-up
Register of advers health events
Time frame: Baseline, 3 and 6 months follow-up
Mesured by Linda Fried criteria (0 positive criteria: robust, 1-2: pre-frail positive criteria, 3 or more positive criteria: frail)
Time frame: Baseline, 3 and 6 months follow-up
Contact information is provided by the study sponsor or research team.
Consorci Sanitari del Maresme
Other
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
Acronym: CREAR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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