An interventional study of Creatine Monohydrate and Placebo in Sarcopenia in Elderly, Frailty at Older Adults and Functional Capacity, sponsored by Consorci Sanitari del Maresme. Recruiting at 1 site in Spain. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Consorci Sanitari del Maresme · Not applicable, Interventional, and Treatment
Among 132 studies in Frailty with a site in Spain — 46 open to participants now, 54 under way, none of them phase 3. Frailty · Spain.
Among the 132 studies in Frailty with a site in Spain, this one is the 13th largest by planned enrollment of the 96 interventional ones that give a count, is one of 16 that started in 2025, is one of 93 with no phase, reaches primary completion later than 38 of the 53 other live ones, and was the 84th registered.
1,284 studies on the registry are indexed under Frailty; 451 are open to participants now.
Browse Frailty studies →46 of the 132 studies in Frailty with a site in Spain are open now. Recruiting first, the newest first:
Universidad de Granada · Sites in Spain
Ages 65+
University of Vigo · Sites in Spain
Ages 70+
Fundacion Miguel Servet · Sites in Spain
Ages 75+
Alberto Bermejo Franco · Sites in Spain
Ages 70+
Fundación para la Investigación del Hospital Clínico de Valencia · Sites in Spain
Ages 65+
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 299 Frailty studies recruiting now, 235 (79%) set no upper age limit and 9 (3%) stop at 75 or younger; 7 take children under 18; 66 take healthy volunteers.
This study: 65 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
132 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 16 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 262 is above the median of 81 across 767 interventional studies indexed under Frailty.
Median enrollment 90 across the 96 interventional studies, 432 across the 36 observational. Of the 60 that completed or were terminated, 2 (3%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 132 have an industry lead sponsor. The 10 most frequent:
Consorci Sanitari del Maresme is the lead sponsor of 15 studies on the registry; 4 are open to participants now.
Consorci Sanitari del Maresme has 3 studies filed under Frailty — fewer than ten, so there is no comparison to draw.
11 of the studies in Frailty with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04926597Philipp SchuetzEffect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery | 2026-12 |
| NCT06556537Universidad de ZaragozaEffects of Physical Exercise on Frailty, Mental and Physical Health of Older Adults in Rural Areas. | 2026-12-20 |
| NCT07275996Universidad de BurgosNeuromuscular and Multi-Omics Synergy of Combined Creatine × HMB Supplementation Plus Exercise to Improve Muscle Function in Sarcopenic Frailty | 2026-12-30 |
| NCT07643064Alberto Bermejo FrancoMulticomponent Exercise and Comprehensive Geriatric Assessment Program (FRAIL+AP) for Frail Older Adults in Primary Care | 2026-12-31 |
| NCT07848802University of VigoPhysical Function and Fall Risk in Older Adults in the Lalín Frailty Prevention Program | 2027-01-15 |
Add all 11 to your calendar (.ics) → With an account.
Among the 132 studies in Frailty with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Creatine Monohydrate
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.
Other: Placebo
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).
Change in muscle mass
Mesured by Bioimpedance Analysis
Time frame: Baseline, 3 and 6 months follow-up
Change in Muscle Strenght
Handgrip mesured by Jamar Dynamometer
Time frame: Baseline, 3 and 6 months follow-up
Change in the prevalence of Sarcopenia
Mesured by EWGSOP2 criteria
Time frame: Baseline, 3 and 6 months follow-up
Change in Functional Capacity
Mesured by Barthel score
Time frame: Baseline, 3 and 6 months follow-up
Changes in Performance
Mesured by Timed Up and Go Test (seconds)
Time frame: Baseline, 3 and 6 months follow-up
Changes in Physical Performance
Mesured by Short Physical Performance Batery (SPPB)
Time frame: Baseline, 3 and 6 months follow-up
Changes in aerobic capacity
Mesured by 6 minutes Walking Test (meters)
Time frame: Baseline, 3 and 6 months follow-up
Changes in Walking Speed
Mesured by Gaid Speed
Time frame: Baseline, 3 and 6 months follow-up
Number of Advers Health Events
Register of advers health events
Time frame: Baseline, 3 and 6 months follow-up
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)
Time frame: Baseline, 3 and 6 months follow-up
Arthroscopy complications
Time frame: Baseline, 3 and 6 months follow-up
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for May 2027, 23 months after the start.
Of 513 non-industry interventional studies with no phase under Frailty, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's planned 23 months is close to that.
Counting every sponsor, half of 517 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Creatine monohydrate
Consorci Sanitari del Maresme