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

NCT06912425 | Completed DMC

• 2 other identifiers: 97/HRCG-JAL/2023AGAF2024/2
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

health belief model; kidney chronic disease; exercise; diet

Outcome Measures

Primary Outcomes (13)

• Changes in total cholesterol

  Total cholesterol: A decrease in values is expected, taking as reference a normal range of \<200 mg/dL. This will indicate a better outcome of the intervention. A change obtained from week 1 to week 12 is expected.

  changes from baseline to week 12

• Changes in HDL cholesterol

  HDL cholesterol: An increase in its values is expected, with a normal range of \>40 mg/dL. The increase will mean better cardiovascular outcomes. Change is expected from week 1 to week 12.

  Changes from baseline measurement to week 12

• LDL cholesterol changes

  LDL cholesterol: A reduction in its levels is expected, considering a reference value \<100 mg/dL. The decrease will mean better cardiovascular outcomes. Evaluation from week 1 to week 12.

  Changes from basal levels up to week 12

• Changes in triglycerides levels

  Triglycerides: a decrease in values is expected, with a reference range \<150 mg/dL. The decrease will mean better cardiovascular outcomes

  Changes from baseline measurement to week 12

• Changes in albumin level

  Albumin: An increase in its values is anticipated, with a normal range of 3.5-5 g/dL. Its increase will be considered an adequate nutritional parameter and a decrease of inflammatory marker. Evaluation from week 1 to week 12.

  Changes from baseline levels to week 12

• Changes in vitamin D levels

  Vitamina D (25-hidroxivitamina D o 25(OH)D): Se espera un aumento de los valores, tomando como referencia un rango de 30-50 ng/mL. Evaluación de la semana 1 a la semana 12.

  Changes from baseline levels at week 12

• Changes in insulin levels

  Insulin: Changes in its values will be analyzed, considering a reference range of 2-25 U/mL. Its increase will be considered a favorable result. Evaluation from week 1 to week 12.

  Changes from baseline to week 12

• Changes in Creatina fosfoquinasa (CK total)

  Creatine Phosphokinase (Total CK): Values are expected to be maintained or increased as a result of adaptation to exercise, with a reference range of 26-192 U/L. Evaluation from week 1 to week 12.

  Changes from baseline to week 12

• Changes in the quality of life questionnaire KDQOL-SF

  Kidney Disease Quality of Life: Improvements are expected in the questionnaire score, ranging from 0 (lowest quality of life) to 100 (highest quality of life). Assessment from week 1 to week 12.

  Changes in initial (week 1) and final responses (week 12)

• Changes in the answers to the questionnaire "Knowledge of the disease".

  Questionnaire "Knowledge of the disease": The changes in the correct answers to the 13 items will be analyzed by means of a score based on the Likert scale. Evaluation from week 1 to week 12.

  changes in initial (week 1) and final responses (week 12)

• Changes in the answers to the questionnaire - Opinion on the disease

  Opinión sobre la enfermedad: Se evaluarán los cambios en la percepción de los participantes sobre su enfermedad, determinando su grado de acuerdo o desacuerdo con diferentes afirmaciones.

  changes in initial (week 1) and final responses (week 12)

• Adherence in exercise frequency

  Exercise frequency: It will be measured by self-reporting, recording the number of weekly sessions and the duration of each one. A greater number of sessions will be considered a better indicator of results. Evaluation from week 1 to week 12.

  initial changes (week 1) and final changes (week 12)

• Changes in grip strength

  Grasping grip strength (dynamometer): An increase in dominant hand grip strength, expressed in kilograms, is expected. Ideal values are \>25 kg, but in this population improvement over baseline measurement will be considered. Assessment from week 1 to week 12.

  changes from the baseline measurement (week 1) to the final week (week 12)

Secondary Outcomes (5)

• Changes in fat mass

  Comparative changes from baseline (week 1) to final measurement (week 12)

• Muscle mass changes

  Comparative changes from baseline (week 1) to final measurement (week 12)

• Changes in body mass index

  Comparative changes from baseline (week 1) to final measurement (week 12)

• Changes in the responses to the questionnaire "frequency of food consumption for the Mexican population"

  changes in responses to the questionnaire "food consumption frequency for the mexican population" comparing initial (week 1) and final (week 12) responses

• Changes in visceral fat

  Changes from baseline measurement (week 1) to final measurement (week 12)

Study Arms (2)

Supervised Exercise Intervention Group

EXPERIMENTAL

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

Behavioral: Health prevention.

Exercise Based on KDIGO Recommendations

EXPERIMENTAL

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.

Behavioral: Health prevention.

Interventions

Health prevention. 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; Supervised Exercise Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

Centro Universitario del Sur

Ciudad Guzmán, Jalisco, 49000, Mexico

Location

Related Publications (1)

• 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.

  PMID: 24451311 BACKGROUND

MeSH Terms

Conditions

Kidney Diseases; Feeding Behavior; Motor Activity; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavior, Animal; Behavior; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effects of an Exercise and Diet Program on Biochemistry and Body Composition in Patients With CKD in G1 and G2 Stages

Model Details: Humans with CKD in stages 1 and 2

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: April 4, 2025
• Study Start: October 1, 2024
• Primary Completion: June 20, 2025
• Study Completion: January 28, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

ME (1)