Chronic Kidney Disease stage3NCT06293092
Effect of Intradialytic Exercises in Chronic Kidney Disease Patients
A study testing leg pedaling cycling device, sand bags and hemodialysis sessions in people with Chronic Kidney Disease stage3, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 50 to 60 years, men only
- Conditions the study is for
- Chronic Kidney Disease stage3
- What is being tested?
- leg pedaling cycling device, sand bags and hemodialysis sessions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2022to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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".
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Chronic Kidney Disease stage3
- Being tested
- leg pedaling cycling device, sand bags, hemodialysis sessions
- Keywords
- Exercise, Dialysis, Kidney Failure, Chronic
- Medical subject headings
- Motor Activity, Renal Insufficiency, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leg pedaling cycling deviceDevice
Intradialytic aerobic cycling exercise program ,each patient will receive the treatment program three times per week for three months.
sand bagsDevice
Intradialytic resistive exercise program , each patient will receive the treatment program three times per week for three months.
hemodialysis sessionsDevice
hemodialysis sessions ,each patient will receive the treatment program three times per week for three months.
| Study group | Role | What they receive |
|---|---|---|
| control group C | Experimental | receive hemodialysis sessions Receives: Device: hemodialysis sessions |
| study group A aerobic exercise | Experimental | receive hemodialysis sessions and intradialytic aerobic exercise Receives: Device: leg pedaling cycling device; Device: hemodialysis sessions |
| study group B resistive exercise | Experimental | receive hemodialysis sessions and intradialytic resistive exercise Receives: Device: sand bags; Device: hemodialysis sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of immunoglobulin g
measured by mg/dl
Measured: baseline , 12 weeks for each patient
Total leukocyte count
measured by (cell/mcl)****1000
Measured: baseline , 12 weeks for each patient
lymphocyte count
measured by (cell/mcl)****1000
Measured: baseline , 12 weeks for each patient
neutrophil count
measured by (cell/mcl)****1000
Measured: baseline , 12 weeks for each patient
Concentration of HbA1c
measured by percentage of blood sugar last 3 months
Measured: baseline , 12 weeks for each patient
Secondary outcomes (6)
hemoglobin concentration
measured by (g/dl)
Measured: baseline , 12 weeks for each patient
thrombocytes count
measured by (cell/mcl)****1000
Measured: baseline , 12 weeks for each patient
diastolic blood pressure
measured by mmHg
Measured: baseline , 12 weeks for each patient
Systolic blood pressure
measured by mmHg
Measured: baseline , 12 weeks for each patient
six minute walk test
measured by meter
Measured: 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
Measured: baseline , 12 weeks for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start30 Apr 2022
- Primary completion30 Oct 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease stage3Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazem Mohamed Yasin Abbas, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293092
- Sponsor's protocol ID
- P.T.REC/012/004008
- Status last verified
- Mar 2024
- First submitted
- 13 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradialytic Aerobic Versus Resistive Exercises on Immunity Response in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06293092
- Acronym / sponsor ID
- P.T.REC/012/004008
- Conditions
- Chronic Kidney Disease stage3
- Keywords
- Exercise, Dialysis, Kidney Failure, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the purpose of this study is to compare between intradialytic aerobic versus resistive exercises on immunity response in patients with chronic kidney disease.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| control group C | Experimental | Device: hemodialysis sessionsreceive hemodialysis sessions |
| study group A aerobic exercise | Experimental | Device: leg pedaling cycling device, Device: hemodialysis sessionsreceive hemodialysis sessions and intradialytic aerobic exercise |
| study group B resistive exercise | Experimental | Device: sand bags, Device: hemodialysis sessionsreceive hemodialysis sessions and intradialytic resistive exercise |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| leg pedaling cycling deviceIntradialytic aerobic cycling exercise program ,each patient will receive the treatment program three times per week for three months. | Device | study group A aerobic exercise |
| sand bagsIntradialytic resistive exercise program , each patient will receive the treatment program three times per week for three months. | Device | study group B resistive exercise |
| hemodialysis sessionshemodialysis sessions ,each patient will receive the treatment program three times per week for three months. | Device | control group C, study group A aerobic exercise, study group B resistive exercise |
Primary outcome
Concentration of immunoglobulin g
Time frame: baseline , 12 weeks for each patient
measured by mg/dl
Total leukocyte count
Time frame: baseline , 12 weeks for each patient
measured by (cell/mcl)****1000
lymphocyte count
Time frame: baseline , 12 weeks for each patient
measured by (cell/mcl)****1000
neutrophil count
Time frame: baseline , 12 weeks for each patient
measured by (cell/mcl)****1000
Concentration of HbA1c
Time frame: baseline , 12 weeks for each patient
measured by percentage of blood sugar last 3 months
6 secondary outcomes
hemoglobin concentration
Time frame: baseline , 12 weeks for each patient
thrombocytes count
Time frame: baseline , 12 weeks for each patient
diastolic blood pressure
Time frame: baseline , 12 weeks for each patient
Systolic blood pressure
Time frame: baseline , 12 weeks for each patient
six minute walk test
Time frame: baseline , 12 weeks for each patient
(KDQOL-SFTM) questionnaire
Time frame: baseline , 12 weeks for each patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
Related trials for Chronic Kidney Disease stage3
Recruiting
Effect of Synbiotic Therapy on Renal Function Outcomes in Patients With Chronic Kidney Disease Stage III-IV: A Double-blind Randomized Placebo-controlled Trial.
Chronic Kidney Disease (Stage 3-4)
Enrolling by invitationObservational study
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
Active, not recruitingObservational study
Metabolic Status and Risk of Chronic Kidney Disease in French Overseas Populations With Morbid Obesity (OBECAMcohort).
Morbid Obesity, Chronic Kidney Disease (Stage 3-4)
Recruiting
Prospective Analysis of Self Medication With Phytotherapy in Nephropatic Patients.
Chronic Kidney Disease (Stage 3-4), Chronic Kidney Disease (Stages 4 and 5)
RecruitingPhase 2
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants
CKD Stage 3, CKD Stage 4
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing leg pedaling cycling device, sand bags and hemodialysis sessions in people with Chronic Kidney Disease stage3, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of immunoglobulin g (time frame: baseline , 12 weeks for each patient). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.