Actively Recruiting
Impact of Creatine Monohydrate Micronized Supplementation With or Without Multicomponent Training in Older Adults.
Led by Fundacion Miguel Servet · Updated on 2025-06-12
120
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of Creatine Monohydrate Micronized Supplementation With or Without Multicomponent Training in Older Adults.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 75 years or older.
- Able to walk with or without personal or technical assistance.
- Life expectancy of 6 months or more.
- Barthel Index greater than 60.
- Provided informed consent by patient or legal representative.
You will not qualify if you...
- Global Deterioration Scale score of 6 or 7.
- Allergy or intolerance to foods or drugs.
- Problems with swallowing (dysphagia).
- Any medical condition that makes physical exercise unsafe.
- Creatine supplementation for less than 6 weeks.
- Consuming more than 200 mg of caffeine daily.
- Currently participating in supervised physical training.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitario de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
Research Team
N
Nicolas Martinez-Velilla, PhD
CONTACT
F
Fabricio Zambom, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
4
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