Effect of Intradialytic Exercises in Chronic Kidney Disease Patients

March 1, 2024 updated by: Hazem Mohamed Yasin Abbas, Cairo University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Fayoum, Egypt
        • Fayoum hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Concentration of immunoglobulin g
Time Frame: baseline , 12 weeks for each patient
measured by mg/dl
baseline , 12 weeks for each patient
Total leukocyte count
Time Frame: baseline , 12 weeks for each patient
measured by (cell/mcl)****1000
baseline , 12 weeks for each patient
lymphocyte count
Time Frame: baseline , 12 weeks for each patient
measured by (cell/mcl)****1000
baseline , 12 weeks for each patient
neutrophil count
Time Frame: baseline , 12 weeks for each patient
measured by (cell/mcl)****1000
baseline , 12 weeks for each patient
Concentration of HbA1c
Time Frame: baseline , 12 weeks for each patient
measured by percentage of blood sugar last 3 months
baseline , 12 weeks for each patient

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
hemoglobin concentration
Time Frame: baseline , 12 weeks for each patient
measured by (g/dl)
baseline , 12 weeks for each patient
thrombocytes count
Time Frame: baseline , 12 weeks for each patient
measured by (cell/mcl)****1000
baseline , 12 weeks for each patient
diastolic blood pressure
Time Frame: baseline , 12 weeks for each patient
measured by mmHg
baseline , 12 weeks for each patient
Systolic blood pressure
Time Frame: baseline , 12 weeks for each patient
measured by mmHg
baseline , 12 weeks for each patient
six minute walk test
Time Frame: baseline , 12 weeks for each patient
measured by meter
baseline , 12 weeks for each patient
(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
baseline , 12 weeks for each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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