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Completed

NCT Number: NCT06293092

Effect of Intradialytic Exercises in Chronic Kidney Disease Patients

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

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Key information

Conditions

Chronic Kidney Disease stage3 Behavior Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Graft vs Host Disease Immune System Diseases Kidney Diseases Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Motor Activity Organizing Pneumonia Renal Insufficiency Respiratory Tract Diseases Urogenital Diseases Urologic Diseases

Age range

50 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Fayoum hospital

Al Fayyum, Egypt

About this study

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

  • Study Group A (20 patients) will receive intradialytic aerobic exercise and medical treatment.
  • Study Group B (20 patients) will receive intradialytic resistive exercise and medical treatment.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

leg pedaling cycling device

Device

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

sand bags

Device

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

hemodialysis sessions

Device

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

Primary outcomes

  1. Concentration of immunoglobulin g

    Time frame: baseline , 12 weeks for each patient

    measured by mg/dl

  2. Total leukocyte count

    Time frame: baseline , 12 weeks for each patient

    measured by (cell/mcl)****1000

  3. lymphocyte count

    Time frame: baseline , 12 weeks for each patient

    measured by (cell/mcl)****1000

  4. neutrophil count

    Time frame: baseline , 12 weeks for each patient

    measured by (cell/mcl)****1000

  5. Concentration of HbA1c

    Time frame: baseline , 12 weeks for each patient

    measured by percentage of blood sugar last 3 months

Secondary outcomes

  1. hemoglobin concentration

    Time frame: baseline , 12 weeks for each patient

    measured by (g/dl)

  2. thrombocytes count

    Time frame: baseline , 12 weeks for each patient

    measured by (cell/mcl)****1000

  3. diastolic blood pressure

    Time frame: baseline , 12 weeks for each patient

    measured by mmHg

  4. Systolic blood pressure

    Time frame: baseline , 12 weeks for each patient

    measured by mmHg

  5. six minute walk test

    Time frame: baseline , 12 weeks for each patient

    measured by meter

  6. (KDQOL-SFTM) questionnaire

    Time frame: baseline , 12 weeks for each patient

    measured by scoring a score-value from 0 (worst health status) to 100 (best health status) was obtained

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 5, 2024
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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