Effects of an Exercise and Diet Program on Biochemistry and Body Composition in Patients With CKD in G1 and G2 Stages

NCT ID: NCT06912425

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-10-28

Brief Summary

How Exercise, a Controlled Diet and Education Improve the Health of People with Early-Stage Renal Failure: A Study at Ciudad Guzmán Hospital

Detailed Description

Chronic kidney disease has a high mortality rate per year, which has led to the search for different intervention strategies to improve adherence to treatment and the promotion of healthy behaviors such as diet and exercise. The latter has been little explored in early stages (G1 and G2) even though its implementation can have an impact on the biochemical parameters of patients and delay their progression. Exercise represents a non-pharmacological, non-invasive, and cost-effective method in health promotion, as it can reduce biomarkers of inflammation such as C-reactive protein, interleukin-6, tumor necrosis factor-α, among others. Despite this, statistics show that 27% of adults in the world do not do the 150 minutes of exercise per week recommended by the World Health Organization (WHO). Regarding medical indications for exercise, there is a prevailing resistance in the medical community regarding its recommendation, given that proteinuria and/or changes in blood pressure linked to this activity are considered to have an impact on renal function. Existing exercise recommendations and proposals are focused on patients on peritoneal dialysis or hemodialysis. One of the most widespread in this patient population are the recommendations made by the WHO for older people with chronic conditions, and more specifically, there are the kidney disease: Improving Global Outcomes (KDIGO) guidelines, however, both give general recommendations, and it has been pointed out as a point of opportunity to explore exercise in this population. The published interventions are limited and do not include biochemical parameters in most of them, nor the physical aptitudes of the patients when performing exercise. On the other hand, it has been identified that the reduction of complications in these patients is associated with healthy behaviors, such as exercise, greater adherence to diet and pharmacological treatment. Several structural barriers have been detected, such as ideological barriers, beliefs, access to treatments, among others, which influence patients' lack of adherence to the plans. Considering the above, the aim of the present research will be to analyze the effects of an exercise program and a protein-controlled diet using an educational intervention on biochemical parameters, muscle strength and body composition in patients with chronic kidney disease in stage G1 and G2. The intervention will be for 3 months and will have two groups: one will follow an exercise program designed for each participant; the second group will follow the exercise recommendation proposed by the KDIGO 2022 guidelines. Both groups will have a personalized dietary plan, educational sessions, body composition and muscle strength assessment monthly. Biochemical parameters such as: creatinine, cystatin C, glucose, urea, urinary sediment, among others, will be evaluated at the beginning and at the end of the intervention to compare changes. Regarding adherence to both the exercise program and the diet, we will seek to reduce the patients' structural barriers by means of educational sessions based on the health belief model (HBM). Topics such as: knowledge of the disease, culinary techniques, barriers that prevent adherence to treatment, among others, will be taught. This project is expected to generate novel knowledge regarding the impact of an educational intervention combined with exercise in patients with chronic kidney disease in early stages. This information may be relevant to guide recommendations in clinical practice guidelines, in addition to promoting the adoption of healthy behaviors such as structured exercise.

Conditions

Kidney Diseases; Diet, Healthy; Dietary Habits; Exercise; Kidney Disease; Educational; Body Composition; Renal Failure , Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Supervised Exercise Intervention Group

This group will be assigned a personalized exercise program designed by the researchers, specialists in kidney disease training. Participants will be assigned to the supervised exercise intervention through a randomization process, ensuring a homogeneous sample

Group Type: EXPERIMENTAL

Health prevention.

Intervention Type: BEHAVIORAL

Unlike other projects, this study focuses on an underexplored area in exercise and kidney disease research. Typically, exercise recommendations are directed toward individuals undergoing hemodialysis or peritoneal dialysis. However, in the early stages of the disease, when the kidneys begin to show alterations, there is no established safe training protocol as a preventive measure. This clinical trial will fill that gap by providing references for an exercise program specifically designed for individuals in the early stages of kidney disease. The main objective will be to compare two different exercise strategies to determine potential benefits for renal health.

Exercise Based on KDIGO Recommendations

To this group will be assigned KDIGO exercise.

This group will be assigned exercise based on KDIGO recommendations. They will be provided with an exercise template according to KDIGO guidelines, without further exercise planning. Additionally, they will receive a protein-controlled diet along with an educational intervention.

Group Type: EXPERIMENTAL

Health prevention.

Intervention Type: BEHAVIORAL

Unlike other projects, this study focuses on an underexplored area in exercise and kidney disease research. Typically, exercise recommendations are directed toward individuals undergoing hemodialysis or peritoneal dialysis. However, in the early stages of the disease, when the kidneys begin to show alterations, there is no established safe training protocol as a preventive measure. This clinical trial will fill that gap by providing references for an exercise program specifically designed for individuals in the early stages of kidney disease. The main objective will be to compare two different exercise strategies to determine potential benefits for renal health.

Interventions

Health prevention.

Unlike other projects, this study focuses on an underexplored area in exercise and kidney disease research. Typically, exercise recommendations are directed toward individuals undergoing hemodialysis or peritoneal dialysis. However, in the early stages of the disease, when the kidneys begin to show alterations, there is no established safe training protocol as a preventive measure. This clinical trial will fill that gap by providing references for an exercise program specifically designed for individuals in the early stages of kidney disease. The main objective will be to compare two different exercise strategies to determine potential benefits for renal health.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Established diagnosis of CKD by the physician in G1 and G2
• Who meet the requirements of normal or decreased filtration rate according to:
• G1: ≥ 90 or G2: 60-89 mL/ min/ 1.73m2
• Alterations in the urinary sediment (cellular cylinders of any type, dysmorphic erythrocytes).
• Confirmation of damage by renal ultrasound (Decreased renal size, thinning of the renal cortex, increased echogenicity of the parenchyma, poor differentiation between the renal cortex and sinus, renal cysts suggestive of cortical or medullary changes).
• Men and women between 18 and 65 years old
• Control of baseline pathologies (glycosylated hemoglobin less than 9%, blood pressure no higher than 140/90mmHg).
• Patients who agree to participate in the study and sign the informed consent form.
• Patients who have no limitations to perform the exercises.
• If participants have diagnosed diabetes or hypertension, who are on medication and under regular internal medicine or nephrology treatment.
• Male and female patients, including those who are illiterate but can be accompanied in the initial sessions to sign the informed consent form.
• All participants, even those who do not have a mobile device, will be provided with an exercise and nutrition guide so that they do not have any limitations when carrying out the activities.

Exclusion Criteria

• Stages 3, 4 and 5
• Children under 18 years of age
• Patients who, due to their place of origin, find it difficult to travel to the sessions.
• Diabetes Mellitus in uncontrolled (Glycated Hemoglobin >9 %)
• Those who have lost their sight
• Presence of uremic alterations such as uremic encephalopathy.
• Who present unstable blood pressure with blood pressure levels above 140/90mmHg, patients showing sustained blood pressure elevations above 140/90 will be discontinued from the study.
• Peripheral vascular disease of all types (Peripheral Arterial Disease (PAD), Deep Vein Thrombosis (DVT), Chronic Venous Disease (CVD), Abdominal Aortic Aneurysm (AAA), Buerger's Phenomenon (Thromboangiitis Obliterans), Kawasaki Disease).
• Failure to sign the informed consent form

Elimination Criteria:

• Injury, discomfort that makes reincorporation impossible.
• Patients who have decided to abandon the study
• Patients who do not attend 2 of the face-to-face sessions, those who do not attend two of their sessions will be taken into consideration.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Ana Patricia Zepeda Salvador

Effects of an Exercise and Diet Program on Biochemistry and Body Composition in Patients With CKD in G1 and G2 Stages

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro Universitario del Sur

Ciudad Guzmán, Jalisco, Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Ana Patricia Zepeda Salvador, PhD

Role: CONTACT

ana.zepeda@cusur.udg.mx

341 575 2222

Facility Contacts

Ana Patricia G Zepeda Salvador, PhD

Role: primary

ana.zepeda@cusur.udg.mx

341 575 2222

References

Ash S, Campbell KL, Bogard J, Millichamp A. Nutrition prescription to achieve positive outcomes in chronic kidney disease: a systematic review. Nutrients. 2014 Jan 22;6(1):416-51. doi: 10.3390/nu6010416.

Reference Type: BACKGROUND

PMID: 24451311 (View on PubMed)

Other Identifiers

AGAF2024/2

Identifier Type: OTHER

Identifier Source: secondary_id

97/HRCG-JAL/2023

Identifier Type: -

Identifier Source: org_study_id