Sarcopenia in ElderlyCREARNCT06925880
Effect of Micronized Creatine Monohydrate on Muscle Mass, Strength and Performance in Older Adults Submitted to Total Knee Arthroplasty
A study testing Creatine Monohydrate in people with Sarcopenia in Elderly and Frailty at Older Adults, run by Consorci Sanitari del Maresme at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia in Elderly, Frailty at Older Adults, Functional Capacity
- What is being tested?
- Creatine Monohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 262 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jun 2025to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Sarcopenia in Elderly, Frailty at Older Adults, Functional Capacity, Creatine Supplementation, Arthroplasties, Knee Replacement, Physical Performance
- Being tested
- Creatine Monohydrate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine MonohydrateDietary 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.
PlaceboOther
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 group | Role | What they receive |
|---|---|---|
| CREATINE | Experimental | 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. Receives: Dietary Supplement: Creatine Monohydrate |
| PLACEBO | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle mass
Mesured by Bioimpedance Analysis
Measured: Baseline, 3 and 6 months follow-up
Change in Muscle Strenght
Handgrip mesured by Jamar Dynamometer
Measured: Baseline, 3 and 6 months follow-up
Change in the prevalence of Sarcopenia
Mesured by EWGSOP2 criteria
Measured: Baseline, 3 and 6 months follow-up
Change in Functional Capacity
Mesured by Barthel score
Measured: Baseline, 3 and 6 months follow-up
Changes in Performance
Mesured by Timed Up and Go Test (seconds)
Measured: Baseline, 3 and 6 months follow-up
Changes in Physical Performance
Mesured by Short Physical Performance Batery (SPPB)
Measured: Baseline, 3 and 6 months follow-up
Changes in aerobic capacity
Mesured by 6 minutes Walking Test (meters)
Measured: Baseline, 3 and 6 months follow-up
Changes in Walking Speed
Mesured by Gaid Speed
Measured: Baseline, 3 and 6 months follow-up
Number of Advers Health Events
Register of advers health events
Measured: Baseline, 3 and 6 months follow-up
Secondary outcomes (2)
Change in Frailty status
Mesured by Linda Fried criteria (0 positive criteria: robust, 1-2: pre-frail positive criteria, 3 or more positive criteria: frail)
Measured: Baseline, 3 and 6 months follow-up
Arthroscopy complications
Measured: Baseline, 3 and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start10 Jun 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenia in ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari del Maresme
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Privada Salut del Consorci Sanitari del Maresme
- Responsible party
- Sponsor
- Investigators
- Jéssica Martínez Rodríguez, Principal investigator, Consorci Sanitari del MaresmeMateu Serra-Prat, PhD, Study director, Consorci Sanitari del Maresme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925880
- Sponsor's protocol ID
- CEIm CSdM 24/25
- Acronym
- CREAR
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06925880
- Acronym / sponsor ID
- CREAR / CEIm CSdM 24/25
- Conditions
- Sarcopenia in Elderly, Frailty at Older Adults, Functional Capacity, Creatine Supplementation, Arthroplasties, Knee Replacement, Physical Performance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- Consorci Sanitari del MaresmeUniversity, hospital or other
- Collaborators
- Fundació Privada Salut del Consorci Sanitari del Maresme
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CREATINE | Experimental | Dietary Supplement: Creatine MonohydrateThe 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. |
| PLACEBO | Placebo comparator | Other: PlaceboThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creatine MonohydrateThe 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. | Dietary supplement | CREATINE |
| PlaceboThe 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). | Other | PLACEBO |
Primary outcome
Change in muscle mass
Time frame: Baseline, 3 and 6 months follow-up
Mesured by Bioimpedance Analysis
Change in Muscle Strenght
Time frame: Baseline, 3 and 6 months follow-up
Handgrip mesured by Jamar Dynamometer
Change in the prevalence of Sarcopenia
Time frame: Baseline, 3 and 6 months follow-up
Mesured by EWGSOP2 criteria
Change in Functional Capacity
Time frame: Baseline, 3 and 6 months follow-up
Mesured by Barthel score
Changes in Performance
Time frame: Baseline, 3 and 6 months follow-up
Mesured by Timed Up and Go Test (seconds)
Changes in Physical Performance
Time frame: Baseline, 3 and 6 months follow-up
Mesured by Short Physical Performance Batery (SPPB)
Changes in aerobic capacity
Time frame: Baseline, 3 and 6 months follow-up
Mesured by 6 minutes Walking Test (meters)
Changes in Walking Speed
Time frame: Baseline, 3 and 6 months follow-up
Mesured by Gaid Speed
Number of Advers Health Events
Time frame: Baseline, 3 and 6 months follow-up
Register of advers health events
2 secondary outcomes
Change in Frailty status
Time frame: Baseline, 3 and 6 months follow-up
Arthroscopy complications
Time frame: Baseline, 3 and 6 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jéssica Martínez Rodríguez principal investigator
Consorci Sanitari del Maresme
Mateu Serra-Prat, PhD study director
Consorci Sanitari del Maresme
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine Monohydrate in people with Sarcopenia in Elderly and Frailty at Older Adults, run by Consorci Sanitari del Maresme at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jéssica Martínez Rodríguez (0034 937417700 ext. 2282, jmartinezro@csdm.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle mass (time frame: Baseline, 3 and 6 months follow-up). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.