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

NCT06677359 | Recruiting

• 1 other identifier: CREAGED
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

creatine; supplementation; multicomponent training; older people

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Muscle Status

  Through study completion, an average of 10 weeks

• Security

  Through study completion, an average of 10 weeks

• Anthropometrical Measurements

  Through study completion, an average of 10 weeks

Study Arms (4)

Control group

PLACEBO COMPARATOR

Participants will recieved placebo supplementation without multicomponent training intervention.

Dietary Supplement: Placebo Group

Creatine group

EXPERIMENTAL

Participants will recieved micronized creatine monohydrate supplementation without multicomponent training intervention.

Dietary Supplement: Creatine Group

Control multicomponent training group

ACTIVE COMPARATOR

Participants will recieved placebo supplementation and multicomponent training intervention

Dietary Supplement: Placebo Group; Other: Multicomponent Training

Creatine multicomponent training group

EXPERIMENTAL

Participants will recieved micronized creatine monohydrate supplementation and multicomponent training intervention.

Dietary Supplement: Creatine Group; Other: Multicomponent Training

Interventions

Creatine Group DIETARY_SUPPLEMENT

Micronized creatine monohydrate supplementation.

Creatine group; Creatine multicomponent training group

Placebo Group DIETARY_SUPPLEMENT

Participants will recieved placebo supplementation

Control group; Control multicomponent training group

Multicomponent Training OTHER

Multicomponent physical exercise intervention

Control multicomponent training group; Creatine multicomponent training group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Miguel Servet: lead

Study Sites (1)

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Study Officials

• Nicolas Martinez-Velilla, PhD

  Navarrabiomed-Fundación Miguel Servet-Hospital de Navarra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Unicenter Randomized Clinical Trial

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: November 6, 2024
• Study Start: November 30, 2024
• Primary Completion: November 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

ES (1)