Chronic Kidney Disease Requiring HemodialysisNCT07045064
Aerobic Versus Resistive Intradialytic Training Effect on Atherogeinc Index in Hemodialysis Patients
A study testing Aerobic exercise without medication, resistive exercise without medication and circulatory exercise without medication in people with Chronic Kidney Disease Requiring Hemodialysis, run by Cairo University at 2 sites in Egypt.
Trial summary
the goal of the clinical trial is to study the effect of aerobic and resistive exercises on atherogenic index in hemodialysis patients the study will include three groups of both sex the first group will participate in aerobic exercise ,the second group will participate in resistive exercise and the third group will… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Chronic Kidney Disease Requiring Hemodialysis
- What is being tested?
- Aerobic exercise without medication, resistive exercise without medication and circulatory exercise without medication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 4 Jul 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- .Maintenance hemodialysis ≥ 3 months. .BMI will be ranged from 18.5 to 29.9 kg/m². .Age ≥ 40years and ≤ 60 years. .Hemodialysis 3 times a week.
Who cannot join
- .patients suffered from any central and peripheral nervous system diseases. .patients suffered from serious complications, such as heart failure, severe infection and malignant tumor.
- .uncontrolled hypertension with systolic blood pressure ⩾200 mm Hg and/or diastolic blood pressure ⩾120 mm Hg.
- .unstable angina
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Not yet recruiting
National Institute of Kidney and Urology, Mataria
Cairo, Select State
mariam rezk lecturer assistant at faculty of physical therapy, 01280207863, mariam.rezk112003@gmail.com
- Recruiting
National Institute of Kidney and Urology, Mataria
Cairo
ahmed hassan head of nephrology department NIUN, prof of nephrology and renal p, 01020372225, ahmed-hassanrama@yahoo.com
About this study
the goal of the clinical trial is to study the effect of aerobic and resistive exercises on atherogenic index in hemodialysis patients the study will include three groups of both sex the first group will participate in aerobic exercise ,the second group will participate in resistive exercise and the third group will be control group
Read the detailed description
This study will be carried out on sixty male and female patients. They will be recruited from National Institute of Kidney and Urology, Mataria,Their ages will be ranged from (40-60) years old these patients will be assigned into three groups (A, B and C). The design of this study will be a randomized controlled trail (RCT).The patients will be informed about the study procedure and signed the informed consent prepared for this study . The study will follow the instructions of ethical committee of faculty of physical therapy, Cairo University. Inclusive criteria
- Maintenance hemodialysis ≥ 3 months.
- BMI will be ranged from 18.5 to 29.9 kg/m².
- Age ≥ 40years and ≤ 60 years.
- Hemodialysis 3 times a week.
Exclusive criteria:
- patients suffered from any central and peripheral nervous system diseases.
- patients suffered from serious complications, such as heart failure, severe infection and malignant tumor.
- uncontrolled hypertension with systolic blood pressure ⩾200 mm Hg and/or diastolic blood pressure ⩾120 mm Hg,
- unstable angina
- Being tested
- Aerobic exercise without medication, resistive exercise without medication, circulatory exercise without medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise without medicationOther
twenty patients will participate in moderate intensity intradialytic aerobic training for 12 weeks. (3 times per week). Using Horizontal electromagnetically braked cycle ergometer during the first half of the dialysis session.
(1) Frequency: received intradialytic, lower-limb, cycling exercise three times per week on alternative days (2) Intensity: the intensity of exercise will be at 12-14 (moderate-intensity: somewhat hard or reports of feeling a little bit tired but still ok to continue) based on the Borg's Perceived Exertion Rating Scale Appendix III (a rating of 6 perceiving "no exertion at all" to 20 perceiving a "maximal exertion" of effort) ,Appropriate speed and grade of resistance were adjusted to achieve the required intensity. (3) Time: the duration of each exercise session consisted of a 5-min warm-up in form of circulatory exercise.
resistive exercise without medicationOther
Twenty patients will participate in moderate intensity intradialytic resistive training for 12 weeks. (3 sessions per week) using ankle weights.
During session: The warming up phase for 5-minute in form of circulatory exercises, then the main exercise phase and then cooling down phase for 5 minutes. in form of circulatory exercises.
The training protocol consisted of five lower-body resistance exercises using ankle weights 3 days/week, The intensity of the program will be moderate, starting with two sets of each exercise at 60% of each patient's three repetition max (3-RM) strength, progressing to three sets per session, with additional weight added as tolerated
circulatory exercise without medicationOther
this group will include 20 patients will participate in circulatory exercises and will be evaluated at the beginning and at the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| arm 1 intervintion : aerobic exercise training without medication | Experimental | Group A:twenty patients of both sex Iintervention :moderate intensity intradialytic aerobic training for 12 weeks. (3 times per week). Using Horizontal electromagnetically braked cycle ergometer during the first half of the dialysis session.
(1) Frequency: received intradialytic, lower-limb, cycling exercise three times per week on alternative days (2) Intensity: the intensity of exercise will be at 12-14 based on the Borg's Perceived Exertion Rating Scale.(a rating of 6 perceiving "no exertion at all" to 20 perceiving a "maximal exertion" of effort) ,Appropriate speed and grade of resistance were adjusted to achieve the required intensity. (3) Time: each session consisted of a a 5-min warm-up in form of ankle pump exercises, 20-min moderate intensity exercise, and 5-min cool-down phase in form of ankle pump exercise. Receives: Other: Aerobic exercise without medication |
| arm2 intervinsion :resistive exercise training without medication | Experimental | Grob B Twenty patients of both sex intervention :this group will participate in moderate intensity intradialytic resistive training without medication for 12 weeks . (3 sessions per week) using ankle weights.
During session: The warming up phase for 5-minute in form of ankle pump exercises, then the main exercise phase and then cooling down phase for 5 minutes. in form of ankle pump exercises.
The training protocol consisted of five lower-body resistance exercises using ankle weights 3 days/week, The intensity of the program will be moderate, starting with two sets of each exercise at 60% of each patient's three repetition max (3-RM) strength, progressing to three sets per session, with additional weight added as tolerated. Receives: Other: resistive exercise without medication |
| arm3 intervention : circulatory exercises training without medication | Experimental | Group C this group will include 20 patients of both sex intervension : patients will participate in ankle pump exercises and will be evaluated at the beginning and at the end of the study. Receives: Other: circulatory exercise without medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
atherogenic index
aterogenic index will be measured through blood test ,an AIP value of under 0.11 is associated with low risk of CVD; the values between 0.11 to 0.21 and upper than 0.21 are associated with intermediate and increased risks, respectively
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start4 Jul 2025
- Primary completionJan 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Requiring HemodialysisStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Rezk Asad Rasheed, Cairo University
- Investigators
- nesreen Vice Dean faculty of physical therapy, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045064
- Sponsor's protocol ID
- exerciseinhemodialysispatients
- Status last verified
- Feb 2025
- First submitted
- 22 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Versus Resistive Intradialytic Training Effect on Atherogeinc Index in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07045064
- Acronym / sponsor ID
- exerciseinhemodialysispatients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 Jul 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 1 Jul 2025 (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 goal of the clinical trial is to study the effect of aerobic and resistive exercises on atherogenic index in hemodialysis patients the study will include three groups of both sex the first group will participate in aerobic exercise ,the second group will participate in resistive exercise and the third group will be control group
Detailed description
This study will be carried out on sixty male and female patients. They will be recruited from National Institute of Kidney and Urology, Mataria,Their ages will be ranged from (40-60) years old these patients will be assigned into three groups (A, B and C). The design of this study will be a randomized controlled trail (RCT).The patients will be informed about the study procedure and signed the informed consent prepared for this study . The study will follow the instructions of ethical committee of faculty of physical therapy, Cairo University. Inclusive criteria
- Maintenance hemodialysis ≥ 3 months.
- BMI will be ranged from 18.5 to 29.9 kg/m².
- Age ≥ 40years and ≤ 60 years.
- Hemodialysis 3 times a week.
Exclusive criteria:
- patients suffered from any central and peripheral nervous system diseases.
- patients suffered from serious complications, such as heart failure, severe infection and malignant tumor.
- uncontrolled hypertension with systolic blood pressure ⩾200 mm Hg and/or diastolic blood pressure ⩾120 mm Hg,
- unstable angina
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| arm 1 intervintion : aerobic exercise training without medication | Experimental | Other: Aerobic exercise without medicationGroup A:twenty patients of both sex Iintervention :moderate intensity intradialytic aerobic training for 12 weeks. (3 times per week). Using Horizontal electromagnetically braked cycle ergometer during the first half of the dialysis session. (1) Frequency: received intradialytic, lower-limb, cycling exercise three times per week on alternative days (2) Intensity: the intensity of exercise will be at 12-14 based on the Borg's Perceived Exertion Rating Scale.(a rating of 6 perceiving "no exertion at all" to 20 perceiving a "maximal exertion" of effort) ,Appropriate speed and grade of resistance were adjusted to achieve the required intensity. (3) Time: each session consisted of a a 5-min warm-up in form of ankle pump exercises, 20-min moderate intensity exercise, and 5-min cool-down phase in form of ankle pump exercise. |
| arm2 intervinsion :resistive exercise training without medication | Experimental | Other: resistive exercise without medicationGrob B Twenty patients of both sex intervention :this group will participate in moderate intensity intradialytic resistive training without medication for 12 weeks . (3 sessions per week) using ankle weights. During session: The warming up phase for 5-minute in form of ankle pump exercises, then the main exercise phase and then cooling down phase for 5 minutes. in form of ankle pump exercises. The training protocol consisted of five lower-body resistance exercises using ankle weights 3 days/week, The intensity of the program will be moderate, starting with two sets of each exercise at 60% of each patient's three repetition max (3-RM) strength, progressing to three sets per session, with additional weight added as tolerated. |
| arm3 intervention : circulatory exercises training without medication | Experimental | Other: circulatory exercise without medicationGroup C this group will include 20 patients of both sex intervension : patients will participate in ankle pump exercises and will be evaluated at the beginning and at the end of the study. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- .Maintenance hemodialysis ≥ 3 months. .BMI will be ranged from 18.5 to 29.9 kg/m². .Age ≥ 40years and ≤ 60 years. .Hemodialysis 3 times a week.
Key exclusion criteria (3 listed)
- .patients suffered from any central and peripheral nervous system diseases. .patients suffered from serious complications, such as heart failure, severe infection and malignant tumor.
- .uncontrolled hypertension with systolic blood pressure ⩾200 mm Hg and/or diastolic blood pressure ⩾120 mm Hg.
- .unstable angina
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 |
|---|---|---|
| Aerobic exercise without medicationtwenty patients will participate in moderate intensity intradialytic aerobic training for 12 weeks. (3 times per week). Using Horizontal electromagnetically braked cycle ergometer during the first half of the dialysis session. (1) Frequency: received intradialytic, lower-limb, cycling exercise three times per week on alternative days (2) Intensity: the intensity of exercise will be at 12-14 (moderate-intensity: somewhat hard or reports of feeling a little bit tired but still ok to continue) based on the Borg's Perceived Exertion Rating Scale Appendix III (a rating of 6 perceiving "no exertion at all" to 20 perceiving a "maximal exertion" of effort) ,Appropriate speed and grade of resistance were adjusted to achieve the required intensity. (3) Time: the duration of each exercise session consisted of a 5-min warm-up in form of circulatory exercise. | Other | arm 1 intervintion : aerobic exercise training without medication |
| resistive exercise without medicationTwenty patients will participate in moderate intensity intradialytic resistive training for 12 weeks. (3 sessions per week) using ankle weights. During session: The warming up phase for 5-minute in form of circulatory exercises, then the main exercise phase and then cooling down phase for 5 minutes. in form of circulatory exercises. The training protocol consisted of five lower-body resistance exercises using ankle weights 3 days/week, The intensity of the program will be moderate, starting with two sets of each exercise at 60% of each patient's three repetition max (3-RM) strength, progressing to three sets per session, with additional weight added as tolerated | Other | arm2 intervinsion :resistive exercise training without medication |
| circulatory exercise without medicationthis group will include 20 patients will participate in circulatory exercises and will be evaluated at the beginning and at the end of the study. | Other | arm3 intervention : circulatory exercises training without medication |
Primary outcome
atherogenic index
Time frame: three months
aterogenic index will be measured through blood test ,an AIP value of under 0.11 is associated with low risk of CVD; the values between 0.11 to 0.21 and upper than 0.21 are associated with intermediate and increased risks, respectively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No
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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.
nesreen Vice Dean faculty of physical therapy, Professor study director
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise without medication, resistive exercise without medication and circulatory exercise without medication in people with Chronic Kidney Disease Requiring Hemodialysis, run by Cairo University at 2 sites 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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mariam rezk rezk, lecturer assistant (01280207863, mariam.rezk112003@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
atherogenic index (time frame: three months). 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 9 Jul 2025.