NCT06677359 Impact of Creatine Monohydrate Micronized Supplementation With or Without Multicomponent Training in Older Adults.
| NCT ID | NCT06677359 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundacion Miguel Servet |
| Condition | Functionality |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-11-30 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-11-30 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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: 1. Does creatine supplementation alone provide physical, functional and cognitive benefits to people over 75 years of age? 2. Is creatine supplementation safe for people over 75 years old? 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: * Engage in a structured multicomponent exercise program designed specifically for elderly patients. This program will include activities focused on strength training, balance exercises, and walking to improve mobility and reduce the risk of falls. * Attend supervised exercise sessions several times a week, allowing for individualized attention and adjustments based on each participants abilities and health status. * Be monitored for changes in functional capacity using standardized assessments, which will measure improvements in mobility, strength, and overall physical functioning. * Undergo cognitive assessments to evaluate any changes in cognitive status throughout the intervention and during follow-up periods after discharge. * Participate in surveys and interviews to assess their quality of life, including physical, emotional, and social well-being, before and after the intervention. * Attend follow-up assessments at designated intervals to track their progress and outcomes, ensuring that any long-term benefits of the exercise program are recognized and documented. Inclusion criteria will focus on individuals aged over 75 years. Participants must be capable of communication and ambulation, either independently or with assistance. * Life expectancy ≥ 6 months. * Barthel Index \> 60. 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.
Eligibility Criteria
Inclusion Criteria: * Age: 75 years or older. * Able to ambulate with or without personal/technical assistance. * Life expectancy ≥ 6 months. * Barthel Index \> 60. * Informed consent by patients, or legal representatives. Exclusion Criteria: * Global Deterioration Scale (GDS 6-7). * Intolerance or allergy foods or drugs. * Deglutition problems (Dx: dysphagia) * Any pathological or metabolic condition incompatible with physical exercise. * Creatine supplementation for less than 6 weeks. * Consumption of more than 200 mg of caffeine daily. * Supervised physical training.
Contact & Investigator
Nicolas Martinez-Velilla, PhD
PRINCIPAL INVESTIGATOR
Navarrabiomed-Fundación Miguel Servet-Hospital de Navarra
Frequently Asked Questions
Who can join the NCT06677359 clinical trial?
This trial is open to participants of all sexes, aged 75 Years or older, studying Functionality. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06677359 currently recruiting?
Yes, NCT06677359 is actively recruiting participants. Contact the research team at nicolas.martinez.velilla@navarra.es for enrollment information.
Where is the NCT06677359 trial being conducted?
This trial is being conducted at Pamplona, Spain.
Who is sponsoring the NCT06677359 clinical trial?
NCT06677359 is sponsored by Fundacion Miguel Servet. The principal investigator is Nicolas Martinez-Velilla, PhD at Navarrabiomed-Fundación Miguel Servet-Hospital de Navarra. The trial plans to enroll 120 participants.