Image

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

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

Recruiting
18-65 years
All
Phase N/A

Powered by AI

Overview

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

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.

Eligibility

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.

Study details
    Kidney Diseases
    Diet
    Healthy
    Dietary Habits
    Exercise
    Kidney Disease
    Educational
    Body Composition
    Renal Failure
    Chronic

NCT06912425

University of Guadalajara

16 April 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.