Effect of Intradialytic Exercises in Chronic Kidney Disease Patients

Chronic Kidney Disease stage3 Clinical Trial

Official title:

Intradialytic Aerobic Versus Resistive Exercises on Immunity Response in Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06293092
• Other study ID #: P.T.REC/012/004008
• Status: Completed
• Phase: N/A
• Start date: April 30, 2022
• Est. completion date: January 30, 2024

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 30, 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease stage3
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Device:
• leg pedaling cycling device
Intradialytic aerobic cycling exercise program ,each patient will receive the treatment program three times per week for three months.
• sand bags
Intradialytic resistive exercise program , each patient will receive the treatment program three times per week for three months.
• hemodialysis sessions
hemodialysis sessions ,each patient will receive the treatment program three times per week for three months.

Locations

Country	Name	City	State
Egypt	Fayoum hospital	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of immunoglobulin g	measured by mg/dl	baseline , 12 weeks for each patient
Primary	Total leukocyte count	measured by (cell/mcl)****1000	baseline , 12 weeks for each patient
Primary	lymphocyte count	measured by (cell/mcl)****1000	baseline , 12 weeks for each patient
Primary	neutrophil count	measured by (cell/mcl)****1000	baseline , 12 weeks for each patient
Primary	Concentration of HbA1c	measured by percentage of blood sugar last 3 months	baseline , 12 weeks for each patient
Secondary	hemoglobin concentration	measured by (g/dl)	baseline , 12 weeks for each patient
Secondary	thrombocytes count	measured by (cell/mcl)****1000	baseline , 12 weeks for each patient
Secondary	diastolic blood pressure	measured by mmHg	baseline , 12 weeks for each patient
Secondary	Systolic blood pressure	measured by mmHg	baseline , 12 weeks for each patient
Secondary	six minute walk test	measured by meter	baseline , 12 weeks for each patient
Secondary	(KDQOL-SFTM) questionnaire	measured by scoring a score-value from 0 (worst health status) to 100 (best health status) was obtained	baseline , 12 weeks for each patient