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NCT Number: NCT06925880

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elisabet Palomera

Mataró, Barcelona, 08304, Spain

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Creatine Monohydrate

Dietary Supplement

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

Other

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).

Primary outcomes

  1. Change in muscle mass

    Time frame: Baseline, 3 and 6 months follow-up

    Mesured by Bioimpedance Analysis

  2. Change in Muscle Strenght

    Time frame: Baseline, 3 and 6 months follow-up

    Handgrip mesured by Jamar Dynamometer

  3. Change in the prevalence of Sarcopenia

    Time frame: Baseline, 3 and 6 months follow-up

    Mesured by EWGSOP2 criteria

  4. Change in Functional Capacity

    Time frame: Baseline, 3 and 6 months follow-up

    Mesured by Barthel score

  5. Changes in Performance

    Time frame: Baseline, 3 and 6 months follow-up

    Mesured by Timed Up and Go Test (seconds)

  6. Changes in Physical Performance

    Time frame: Baseline, 3 and 6 months follow-up

    Mesured by Short Physical Performance Batery (SPPB)

  7. Changes in aerobic capacity

    Time frame: Baseline, 3 and 6 months follow-up

    Mesured by 6 minutes Walking Test (meters)

  8. Changes in Walking Speed

    Time frame: Baseline, 3 and 6 months follow-up

    Mesured by Gaid Speed

  9. Number of Advers Health Events

    Time frame: Baseline, 3 and 6 months follow-up

    Register of advers health events

Secondary outcomes

  1. Change in Frailty status

    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)

  2. Arthroscopy complications

    Time frame: Baseline, 3 and 6 months follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Jéssica Martínez Rodríguez

CONTACT

[email protected]

0034 937417700 ext. 2282

Sponsors and collaborators

Lead sponsor

Consorci Sanitari del Maresme

Other

Collaborators

  • Fundació Privada Salut del Consorci Sanitari del Maresme

Registry information

Official study 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

Acronym: CREAR

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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