Effect of Intradialytic Exercises in Chronic Kidney Disease Patients

NCT06293092 | Completed

• 1 other identifier: P.T.REC/012/004008
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease stage3

Keywords

Exercise; Dialysis; Kidney Failure; Chronic

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• hemoglobin concentration

  baseline , 12 weeks for each patient

• thrombocytes count

  baseline , 12 weeks for each patient

• diastolic blood pressure

  baseline , 12 weeks for each patient

• Systolic blood pressure

  baseline , 12 weeks for each patient

• six minute walk test

  baseline , 12 weeks for each patient

Study Arms (3)

control group C

EXPERIMENTAL

receive hemodialysis sessions

Device: hemodialysis sessions

study group A aerobic exercise

EXPERIMENTAL

receive hemodialysis sessions and intradialytic aerobic exercise

Device: leg pedaling cycling device; Device: hemodialysis sessions

study group B resistive exercise

EXPERIMENTAL

receive hemodialysis sessions and intradialytic resistive exercise

Device: sand bags; Device: hemodialysis sessions

Interventions

leg pedaling cycling device DEVICE

Intradialytic aerobic cycling exercise program ,each patient will receive the treatment program three times per week for three months.

study group A aerobic exercise

sand bags DEVICE

Intradialytic resistive exercise program , each patient will receive the treatment program three times per week for three months.

study group B resistive exercise

hemodialysis sessions DEVICE

hemodialysis sessions ,each patient will receive the treatment program three times per week for three months.

control group C; study group A aerobic exercise; study group B resistive exercise

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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".

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Fayoum hospital

Al Fayyum, Egypt

Location

MeSH Terms

Conditions

Motor Activity; Renal Insufficiency; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Behavior; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist

Model Details: 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

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: March 5, 2024
• Study Start: April 30, 2022
• Primary Completion: October 30, 2023
• Study Completion: January 30, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

EG (1)