Effect of an Intradialytic Physical Exercise Programme Supplemented With Creatine Monohydrate on Body Composition, Biochemical Parameters and Functionality in Patients With Stage 5 Chronic Kidney Disease Undergoing Haemodialysis: Phase II Double-blind Randomised Clinical Trial.
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 48
- Locations
- 1
Study Overview
Brief Summary
This study aims to evaluate the effects of creatine monohydrate supplementation and an intradialytic exercise program on body composition, biochemical parameters, and functional capacity in patients with chronic kidney disease (CKD) undergoing maintenance hemodialysis. The study will compare the independent and combined effects of these interventions over an 8-week period to determine their potential benefits in this patient population.
Detailed Description
A double-blind, randomized clinical trial will be conducted in patients with chronic kidney disease undergoing maintenance hemodialysis. The study will evaluate the effects of creatine monohydrate supplementation and an intradialytic exercise program on body composition, biochemical parameters, and functional capacity.
Participants will be allocated to one of four study groups: (1) standard hemodialysis care, (2) creatine monohydrate supplementation, (3) intradialytic exercise, and (4) creatine monohydrate supplementation combined with intradialytic exercise. The intervention period will last 8 weeks.
Body composition, biochemical parameters, and functional capacity will be assessed at baseline and after completion of the intervention period. Comparisons among study groups will be performed to determine the independent and combined effects of creatine monohydrate supplementation and intradialytic exercise.
The study is designed to generate evidence regarding the potential clinical benefits of incorporating structured exercise programs and creatine supplementation into the routine management of patients receiving maintenance hemodialysis. Findings may contribute to the development of strategies aimed at improving physical function, nutritional status, and overall health outcomes in this population.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
The study will be double-blind, meaning that patients will not know which treatment group they are in, and the principal investigator will not know which patients are taking creatine monohydrate or a placebo.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •atients who are treated at the State Haemodialysis Centre.
- •Patients who receive haemodialysis three times a week.
- •Signature of informed consent.
- •Patients over 18 years of age, both men and women.
- •Patients who have been on haemodialysis for no more than two years.
Exclusion Criteria
- •Patients who have had a limb amputated.
- •Patients who are in a state of anuria.
- •Inability to perform muscular resistance or aerobic resistance exercises.
- •Patients unable to perform physical exercise.
- •HIV-positive patients. Elimination.
- •Patients who voluntarily withdraw from the project.
- •Inability to perform physical exercise.
- •Adverse events related to creatine consumption.
Investigators
Pedro Julian Flores Moreno
Ph.D. in Science
Universidad de Colima