Effect of Intradialytic Exercises in Chronic Kidney Disease Patients

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease stage3
• Intervention / Treatment: Device: hemodialysis sessions; Device: leg pedaling cycling device; Device: sand bags

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Fayoum, Egypt
    • Fayoum hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: control group C; receive hemodialysis sessions	Device: hemodialysis sessions; hemodialysis sessions ,each patient will receive the treatment program three times per week for three months.
Experimental: study group A aerobic exercise; receive hemodialysis sessions and intradialytic aerobic exercise	Device: hemodialysis sessions; hemodialysis sessions ,each patient will receive the treatment program three times per week for three months.; Device: leg pedaling cycling device; Intradialytic aerobic cycling exercise program ,each patient will receive the treatment program three times per week for three months.
Experimental: study group B resistive exercise; receive hemodialysis sessions and intradialytic resistive exercise	Device: hemodialysis sessions; hemodialysis sessions ,each patient will receive the treatment program three times per week for three months.; Device: sand bags; Intradialytic resistive exercise program , each patient will receive the treatment program three times per week for three months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of immunoglobulin g	measured by mg/dl	baseline , 12 weeks for each patient
Total leukocyte count	measured by (cell/mcl)****1000	baseline , 12 weeks for each patient
lymphocyte count	measured by (cell/mcl)****1000	baseline , 12 weeks for each patient
neutrophil count	measured by (cell/mcl)****1000	baseline , 12 weeks for each patient
Concentration of HbA1c	measured by percentage of blood sugar last 3 months	baseline , 12 weeks for each patient

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hemoglobin concentration	measured by (g/dl)	baseline , 12 weeks for each patient
thrombocytes count	measured by (cell/mcl)****1000	baseline , 12 weeks for each patient
diastolic blood pressure	measured by mmHg	baseline , 12 weeks for each patient
Systolic blood pressure	measured by mmHg	baseline , 12 weeks for each patient
six minute walk test	measured by meter	baseline , 12 weeks for each patient
(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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2022
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Estimated): March 5, 2024

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Dialysis; Chronic; Kidney Failure
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: P.T.REC/012/004008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No