Impact of Creatine Monohydrate Micronized Supplementation With or Without Multicomponent Training in Older Adults.

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.

Conditions

• Functionality
• Cognition
• Strength Training Effects

Interventions

DIETARY_SUPPLEMENT

Creatine Group

Micronized creatine monohydrate supplementation.

DIETARY_SUPPLEMENT

Placebo Group

Participants will recieved placebo supplementation

OTHER

Multicomponent Training

Multicomponent physical exercise intervention

Sponsors & Collaborators

• Fundacion Miguel Servet

  lead OTHER

Principal Investigators

• Nicolas Martinez-Velilla, PhD · Navarrabiomed-Fundación Miguel Servet-Hospital de Navarra

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-11-30

Primary Completion

2025-11-01

Completion

2026-12-01

Countries

• Spain

Study Locations