Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to study and evaluate whether a protocol of creatine supplementation, with or without multicomponent training, improves functional and cognitive capacity in individuals over 75 years old. The results of this study will further our understanding of creatine supplementation effects in the context of older patients and in combination with multicomponent training, thereby enhancing patient care strategies. Additionally, the goal is to improve the quality of life for the elderly and the efficiency of the healthcare system.
The main questions it aims to answer are:
Researchers will compare creatine monohydrate supplementation with or without multicomponent training intervention to placebo supplementation with or without multicomponent training intervention to see if the creatine supplementation protocol leads to significant improvements in functional and cognitive outcomes. This comparison will help determine the effectiveness of the supplementation intervention in enhancing the overall well-being of elderly patients.
Participants will:
Inclusion criteria will focus on individuals aged over 75 years. Participants must be capable of communication and ambulation, either independently or with assistance.
Exclusion criteria will ensure the safety and appropriateness of the intervention. Individuals who explicitly refuse to participate or cannot provide informed consent will be excluded. Additionally, those with a life expectancy of less than three months, terminal illnesses, or significant medical contraindications for exercise will not be eligible. Participants with moderate to severe neurocognitive disorders or disabilities that severely limit mobility will also be excluded to maintain the integrity of the intervention.
This clinical trial aims to recruit a total of 120 participants from the Geriatric Department or Primary Care, providing a comprehensive dataset to analyze the effectiveness and safety of the multicomponent exercise program. By examining the outcomes related to functional capacity, cognitive status, and quality of life, the study seeks to provide valuable insights into the benefits of physical activity for elderly patients during hospitalization.
The goal of this clinical trial is to study and evaluate whether a protocol of creatine supplementation, with or without multicomponent training, improves functional and cognitive capacity in individuals over 75 years old. The results of this study will further our understanding of creatine supplementation effects in the context of older patients and in combination with multicomponent training, thereby enhancing patient care strategies. Additionally, the goal is to improve the quality of life for the elderly and the efficiency of the healthcare system.
The main questions it aims to answer are:
Researchers will compare creatine monohydrate supplementation with or without multicomponent training intervention to placebo supplementation with or without multicomponent training intervention to see if the creatine supplementation protocol leads to significant improvements in functional and cognitive outcomes. This comparison will help determine the effectiveness of the supplementation intervention in enhancing the overall well-being of elderly patients.
Participants will:
Inclusion criteria will focus on individuals aged over 75 years. Participants must be capable of communication and ambulation, either independently or with assistance.
The inclusion criteria will focus on individuals aged over 75 years, also:
Exclusion criteria will ensure the safety and appropriateness of the intervention. Individuals who explicitly refuse to participate or cannot provide informed consent will be excluded. Additionally, those with a life expectancy of less than three months, terminal illnesses, or significant medical contraindications for exercise will not be eligible. Participants with moderate to severe neurocognitive disorders or disabilities that severely limit mobility will also be excluded to maintain the integrity of the intervention.
Sample Size and Recruitment: This clinical trial aims to recruit a total of 120 participants. Recruitment will be conducted through Geriatric Department or Primary Care, with potential participants identified by medical staff and referred to the research team. Informed consent will be obtained from all participants or their legal representatives prior to enrollment.
Data Collection and Analysis: Data will be collected at baseline, during the intervention, and at follow-up assessments. This will include demographic information, clinical history, baseline functional and cognitive assessments, and post-intervention evaluations. Statistical analyses will be performed to compare outcomes between the intervention and control groups, using appropriate methods to account for potential confounding factors.
Ethical Considerations: This study will adhere to ethical guidelines for research involving human subjects. The protocol will be reviewed and approved by the Institutional Review Board (IRB) at each participating center. Informed consent will be obtained from all participants, ensuring they understand the study purpose, procedures, risks, and benefits.
Expected Outcomes: The findings of this study may provide valuable insights into the impact of creatine monohydrate supplementation for elderly participants. By examining the outcomes related to functional capacity, cognitive status and quality of life, the study seeks to inform future guidelines and practices for improving the care of older adults. Additionally, the research may contribute to the understanding of how creatine supplementation can positively influence health at the molecular level, potentially leading to new therapeutic approaches for managing health in elderly populations.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Participants will recieved placebo supplementation without multicomponent training intervention. |
|
| Creatine group | Experimental | Participants will recieved micronized creatine monohydrate supplementation without multicomponent training intervention. |
|
| Control multicomponent training group | Active Comparator | Participants will recieved placebo supplementation and multicomponent training intervention |
|
| Creatine multicomponent training group | Experimental | Participants will recieved micronized creatine monohydrate supplementation and multicomponent training intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Creatine Group | Dietary Supplement | Micronized creatine monohydrate supplementation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Function | Short Performance Physical Battery (SPPB) | Through study completion, an average of 10 weeks |
| Strength | Maximus Repetition (RM) | Through study completion, an average of 10 weeks |
| Cognition | Cognition Test: MMSE. | Through study completion, an average of 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Status | Muscle ultrasound. | Through study completion, an average of 10 weeks |
| Security | Glomerular filtration rate (GFR) | Through study completion, an average of 10 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas Martinez-Velilla, PhD | Contact | 00 34 848422222 | nicolas.martinez.velilla@navarra.es | |
| Fabricio Zambom, PhD | Contact | 00 34 848422222 | fabricio.zambom.ferraresi@navarra.es |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas Martinez-Velilla, PhD | Navarrabiomed-Fundación Miguel Servet-Hospital de Navarra | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42093614 | Derived | Fernandez-Gonzalez de la Riva M, Zambom-Ferraresi F, Zambom-Ferraresi F, Izco-Cubero M, Alvarez-Rodriguez P, Zugasti-Murillo A, Echeverria-Beistegui I, Cedeno-Veloz BA, Marcos-Perez D, Capon-Saez A, Moral-Cuesta D, Soto-Ruiz N, Martinez-Velilla N. Impact of creatine monohydrate supplementation combined with multicomponent training in older adults (>/= 75 years): study protocol of a randomised controlled trial. Br J Nutr. 2026 May 7:1-10. doi: 10.1017/S0007114526107302. Online ahead of print. |
Not provided
Not provided
Not provided
Unicenter Randomized Clinical Trial
Not provided
Not provided
Not provided
| Placebo Group | Dietary Supplement | Participants will recieved placebo supplementation |
|
| Multicomponent Training | Other | Multicomponent physical exercise intervention |
|
| Anthropometrical Measurements | Bioimpedance: PHASE ANGLE (PhA), Fat-Free Mass (FFM) and Muscle Mass (MM) | Through study completion, an average of 10 weeks |