Clinical trial NCT06293092: Effect of Intradialytic Exercises in Chronic Kidney Disease Patients
Official title: Intradialytic Aerobic Versus Resistive Exercises on Immunity Response in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease stage3
Keywords: Exercise
Dialysis
Kidney Failure
Chronic
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 60
Sex: MALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control group receive medical treatment only ,first study group receive medical treatment and intradialytic aerobic exercise , second study group receive medical treatment and intradialytic resistive exercise
Primary purpose: TREATMENT

Brief summary: the purpose of this study is to compare between intradialytic aerobic versus resistive exercises on immunity response in patients with chronic kidney disease.

Detailed description: The patients of this study will randomly assigned into three equal groups (n=20)

1. Study Group A (20 patients) will receive intradialytic aerobic exercise and medical treatment.
2. Study Group B (20 patients) will receive intradialytic resistive exercise and medical treatment.
3. Control Group C (20 patients) will receive medical treatment only (HD session and drugs) Each patient will receive the treatment program three times per week for three months.

Eligibility criteria: Inclusion Criteria:

* Sixty men chronic kidney disease (grade III RF). They received regular hemodialysis sessions at least one year ago, each one for four hours, three times per week.
* They had a history of type II Diabetes more than five years.
* Their age will be ranged from 50-60 years old.
* They are Fit for exercise by functional assessment using six minute walk test.
* Their Hemoglobin level more than 10 g\\dl.
* Their Body Mass Index (BMI) will be ranged from "18.5" to "24.9".

Exclusion Criteria:

* Severe cardiac disorders.
* Severe orthopedic problems (for example fractures).
* Hepatic encephalopathy.
* Preexisting neuromuscular diseases (e.g. myasthenia gravis). •Severe chest diseases.
* Spinal cord injuries involved the phrenic nerve.
* Uncontrolled diabetes or hypertension
* Patients receiving inefficient hemodialysis session.
* Patients with other cause for inflammation e.g. malignancy and autoimmune disease.
* Active bleeding as alveolar hemorrhage, hemoptysis.
* Physical limitation that would limit cycling.

Primary outcomes:
measure: Concentration of immunoglobulin g
timeFrame: baseline , 12 weeks for each patient
measure: Total leukocyte count
timeFrame: baseline , 12 weeks for each patient
measure: lymphocyte count
timeFrame: baseline , 12 weeks for each patient
measure: neutrophil count
timeFrame: baseline , 12 weeks for each patient
measure: Concentration of HbA1c
timeFrame: baseline , 12 weeks for each patient
Secondary outcomes:
measure: hemoglobin concentration
timeFrame: baseline , 12 weeks for each patient
measure: thrombocytes count
timeFrame: baseline , 12 weeks for each patient
measure: diastolic blood pressure
timeFrame: baseline , 12 weeks for each patient
measure: Systolic blood pressure
timeFrame: baseline , 12 weeks for each patient
measure: six minute walk test
timeFrame: baseline , 12 weeks for each patient
measure: (KDQOL-SFTM) questionnaire
timeFrame: baseline , 12 weeks for each patient
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum hospital
Study officials:
References: