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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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, snack and dinner). Subsequently, a maintenance dose of 5g/day will be continued for 11 weeks (breakfast).

Study 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

Primary outcome measure(s)

• Change in muscle mass — Baseline, 3 and 6 months follow-up
  Mesured by Bioimpedance Analysis
• Change in Muscle Strenght — Baseline, 3 and 6 months follow-up
  Handgrip mesured by Jamar Dynamometer
• Change in the prevalence of Sarcopenia — Baseline, 3 and 6 months follow-up
  Mesured by EWGSOP2 criteria
• Change in Functional Capacity — Baseline, 3 and 6 months follow-up
  Mesured by Barthel score
• Changes in Performance — Baseline, 3 and 6 months follow-up
  Mesured by Timed Up and Go Test (seconds)
• Changes in Physical Performance — Baseline, 3 and 6 months follow-up
  Mesured by Short Physical Performance Batery (SPPB)
• Changes in aerobic capacity — Baseline, 3 and 6 months follow-up
  Mesured by 6 minutes Walking Test (meters)
• Changes in Walking Speed — Baseline, 3 and 6 months follow-up
  Mesured by Gaid Speed
• Number of Advers Health Events — Baseline, 3 and 6 months follow-up
  Register of advers health events

Trial sites (1)

Other trials for the same condition