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| Name | Class |
|---|---|
| Fundació Privada Salut del Consorci Sanitari del Maresme | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in muscle mass | Mesured by Bioimpedance Analysis | Baseline, 3 and 6 months follow-up |
| Change in Muscle Strenght | Handgrip mesured by Jamar Dynamometer | Baseline, 3 and 6 months follow-up |
| Change in the prevalence of Sarcopenia | Mesured by EWGSOP2 criteria | Baseline, 3 and 6 months follow-up |
| Change in Functional Capacity | Mesured by Barthel score | Baseline, 3 and 6 months follow-up |
| Changes in Performance | Mesured by Timed Up and Go Test (seconds) | Baseline, 3 and 6 months follow-up |
| Changes in Physical Performance | Mesured by Short Physical Performance Batery (SPPB) | Baseline, 3 and 6 months follow-up |
| Changes in aerobic capacity | Mesured by 6 minutes Walking Test (meters) | Baseline, 3 and 6 months follow-up |
| Changes in Walking Speed | Mesured by Gaid Speed | Baseline, 3 and 6 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, 3 and 6 months follow-up |
| Arthroscopy complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jéssica MartÃnez RodrÃguez | Contact | 0034 937417700 | 2282 | jmartinezro@csdm.cat |
| Name | Affiliation | Role |
|---|---|---|
| Jéssica MartÃnez RodrÃguez | Consorci Sanitari del Maresme | Principal Investigator |
| Mateu Serra-Prat, PhD | Consorci Sanitari del Maresme | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elisabet Palomera | Recruiting | Mataró | Barcelona | 08304 | Spain |
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|
| 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). |
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| Number of Advers Health Events |
Register of advers health events |
| Baseline, 3 and 6 months follow-up |
| Baseline, 3 and 6 months follow-up |
| ID | Term |
|---|---|
| D003401 | Creatine |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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