Hemodialysis ComplicationNCT07054827
Effect of Intradialytic Resistance Versus Aerobic Exercise on Cardiovascular System in Patients on Regular Hemodialysis
A study testing Hemodialysis, Intradialytic resistive exercise and Intradialytic aerobic exercise in people with Hemodialysis Complication, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is to compare the effect of resistance exercise and aerobic exercise on intradialytic hypotension in patients undergoing hemodialysis. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- Hemodialysis, Intradialytic resistive exercise and Intradialytic aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jul 2025to 20 Nov 2025
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End-stage renal disease (ESRD) or stage 5 chronic kidney disease (CKD) in which on maintenance regular HD (three sessions/week (on alternate days), for four hours/session for more than a year to five years when starting the study.
- Both gender male and female aged from 45 to 60 years old.
- Patients with intradialytic hypotension sudden drops of systolic pressure of more than 20 mm Hg or diastolic pressure of more than 10 mmHg.
- Receiving hemodialysis (HD) through uncomplicated arm arteriovenous (A-V) fistula.
- Patients with Body Mass Index (BMI): 18,5 < 30kg/m2.
- In a stable medical, clinical, and hemodynamic condition
- Untrained at baseline and did not participate in any regular physical activity before.
Who cannot join
- Severe Chest diseases (either obstructive or restrictive).
- Clinical signs of a severe cardiac event. (eg, severe atherosclerosis, congestive heart failure),
- Severe psychiatric or cognitive impairment, who unable to follow comment.
- Neurological disorders affecting respiratory muscles or any muscular dystrophies (cervical disc or bulge).
- Patients with severe self-limiting illness (e.g., cancer).
- Patients with Body Mass Index (BMI) > 30kg/m2.
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- Previous renal transplantation patients.
- Pregnant females or became pregnant during the study.
- Patients started HD in less than a year or more than 5 years.
- Hospitalized during the prior month.
- Patients who were irregular in HD or not adherent to the exercise program.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of the study is to compare the effect of resistance exercise and aerobic exercise on intradialytic hypotension in patients undergoing hemodialysis.
Read the detailed description
Chronic kidney disease (CKD) is one of the leading causes of global morbidity and mortality. In the 2019 Global Burden of Disease study, CKD was among the top ten risks associated with the highest number of deaths worldwide, with a death toll of 3.16 million deaths.
Patients undergoing dialysis in Egypt in 2020 are mostly men (59%), and half of them are aged ≥55 years. Hypertension is the most common cause of end-stage kidney disease at 41%, followed by diabetes at 14%, whereas glomerulonephritis is the primary diagnosis in 3% of patients undergoing dialysis.
Hemodialysis (HD), continuous ambulatory peritoneal dialysis, and kidney transplantation are the three main modalities of renal replacement therapy. Hypotension is the most reported complication of routine outpatient HD treatments.
Toxic substances, also called uremic toxins, in the blood result in malaise, paraesthesia, mental impairment, peripheral circulatory disturbance, and muscle dysfunction.
While patients exercise during dialysis, those toxins move through the dialyzer with a large flux from the tissue to the vascular compartment. It results in increased muscle blood flow and opened capillary surface area. Besides, the intradialytic exercise showed not only better adoption and adherence but also a lower drop-out and greater compliance.
So, this study will investigate the effect of resistance and aerobic exercises on intradialytic hypotension in patients undergoing hemodialysis. thus, may affect the quality of life in chronic kidney disease dialysis patients. The results of this study may shed light on which of the selected exercises can decrease the risk of Intradialytic hypotension to help dialysis patients. To our knowledge, there are no previous similar studies.
- Conditions
- Hemodialysis Complication
- Being tested
- Hemodialysis, Intradialytic resistive exercise, Intradialytic aerobic exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemodialysisOther
The participants receive hemodialysis for 4 hours, 3 times per week
Intradialytic resistive exerciseOther
The participants will receive intradialytic resistive exercise for 12 weeks (3 sessions/ week).
Duration: 30 minutes during the first 2 hours of each dialysis session in a recumbent position or seated position.
Time of session: The program starts with a warm-up phase which is 3:5 minutes in the form of light aerobic and stretching exercises for big muscles and ends with a cooling down phase which is 3:5 in the form of light aerobic exercise.
The resistance exercises include exercises for the big muscles of only the Lower Limbs (LL) muscles of single and multiple-joint which are:1- Knee extensors, 2- Knee flexors, 3- Hip flexors, 4- Hip abductors and adductors. using sandbags of different weights. Sandbag weights are placed on the distal third of the tibia for LL exercises.
Intensity: On the Borg's Scale of Perceived Exertion, which will be measured every 5 minutes during exercise.
Intradialytic aerobic exerciseOther
Patients with chronic kidney disease will receive an intradialytic aerobic exercise for 12 weeks (3 sessions/ week).
Duration: 30 minutes during the first 2 hours of each dialysis session using a stationary bicycle ergometer in a supine position or seated position.
Time of session: The warming up and the cooling down phase consists of 5:10 minutes of slow Pedaling. the main exercise phase consisted of 20 minutes of cycling.
Intensity: The use of the Borg's Scale of Perceived Exertion (RPE) scale enables the intensity of the exercise to be adapted According to the tolerance of each patient.
The use of the RPE scale enables the intensity of the exercise to be adapted According to the tolerance of each patient, the aim was to obtain between 11 light And 14 somewhat hard.
| Study group | Role | What they receive |
|---|---|---|
| Medical therapy group | Active comparator | Patients with chronic kidney disease will receive hemodialysis only, for four hours, 3 times per week. Receives: Other: Hemodialysis |
| intra-dialytic resistive exercise group | Experimental | Patients with chronic kidney disease will receive an intra-dialytic resistance exercise for 12 weeks (3 sessions/week) in addition to hemodialysis. Receives: Other: Hemodialysis; Other: Intradialytic resistive exercise |
| intra-dialytic aerobic exercise group | Experimental | Patients with chronic kidney disease will receive an intra-dialytic aerobic exercise (leg pedaling) for 12 weeks (3 sessions/week) in addition to hemodialysis. Receives: Other: Hemodialysis; Other: Intradialytic aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure measurement
Blood pressure (BP) will be measured on the non-access arm using automatic BP cuffs attached to the patient's hemodialysis machine which is used routinely at each respective hemodialysis clinic. As well as for ankle brachial pressure index. Systolic blood pressure measurements will be taken pre-hemodialysis, at hemodialysis start (baseline), post-hemodialysis, and every 15 minutes during each dialysis session. BP measurements will be taken before selected exercise and after exercise.
Measured: 12 weeks
Diastolic blood pressure measurement
Blood pressure (BP) will be measured on the non-access arm using automatic BP cuffs attached to the patient's hemodialysis machine which is used routinely at each respective hemodialysis clinic. As well as for ankle brachial pressure index. diastolic blood pressure measurements will be taken pre-hemodialysis, at hemodialysis start (baseline), post-hemodialysis, and every 15 minutes during each dialysis session. BP measurements will be taken before selected exercise and after exercise.
Measured: 12 weeks
Ankle-Brachial Index (ABI)
This non-invasive test compares blood pressure in the ankles to blood pressure in the arms. An ABI below 0.9 usually suggests peripheral artery disease (PAD), a common cause of circulatory issues.
Measured: 12 weeks
Peripheral oxygen saturation
Pulse oximetry is a non-invasive method used to measure the oxygen saturation level (SpO2) in the blood, providing an estimate of how much oxygen the hemoglobin in red blood cells is carrying. It provides data on oxygen delivery to extremities, which may be impaired in circulation issues. Normally, its value is 95-99%.
Measured: 12 weeks
Creatinine level
Blood analysis will be used to measure creatinine level for all patients before and after intervention. Its values vary by sex; 0.6-1.2 mg/dl for men and 0.5-1.1 mg/dl for women.
Measured: 12 weeks
blood urea level
Blood analysis will be used to measure blood urea for all patients before and after intervention. its normal value ranges from 17-43 mg/dl.
Measured: 12 weeks
blood urea nitrogen test
Blood analysis will be used to measure blood urea nitrogen for all patients before and after intervention. its normal value ranges from 7-20 mg/dl.
Measured: 12 weeks
serum albumin
Blood analysis will be used to measure serum albumin for all patients before and after intervention. its normal value in adults is typically 3.5-5.0 g/L.
Measured: 12 weeks
Secondary outcomes (2)
Six minutes walking Test (6 MWT)
A 6-minute walk test (6MWT) is a major physical test in the dialysis population. Its value lies in the fact that it is a self-paced test of walking capacity and functional ability of daily physical activities which are mostly performed at submaximal level of exertion.
6MWT is a major physical tests in dialysis population. Its value lies in the fact that it is a self-paced test of walking capacity and reflects the functional ability at daily physical activities which are mostly performed at submaximal level of exertion. It is carried out in a 30 m long corridor. Subjects will be instructed to walk from end to end of the corridor and to cover the greatest distance possible in six minutes. Patients who need rest due to dyspnea will be instructed to continue walking as soon as they feel able, but the timer doesn't stop.
Measured: 12 weeks
The Kidney Disease Quality of Life Short Form (KDQOL-SF)
is a self-reported measure of health that particularly concerns individuals with chronic kidney disease (CKD). The KDQOL-36 is a short version of KDQOL-SF that includes only 36 questions.
The survey can be administered in 3-5 min, which saves both time and resources. Each subscale score ranges between 0 and 100, with increasing values equating to better health.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start5 Jul 2025 (estimated)
- Primary completion5 Nov 2025 (estimated)
- Study completion20 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies 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
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Mohamed Mahmoud Gouda, Cairo University
- Investigators
- Sahier El-Khashab, Professor, Study director, Cairo UniversityNagwa Badr, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054827
- Sponsor's protocol ID
- P.T.REC/012/005770
- Status last verified
- Jun 2025
- First submitted
- 28 Jun 2025
- Last updated
- 8 Jul 2025
- 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 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intradialytic Resistance Versus Aerobic Exercise on Cardiovascular System in Patients on Regular Hemodialysis
- ClinicalTrials.gov ID
- NCT07054827
- Acronym / sponsor ID
- P.T.REC/012/005770
- Conditions
- Hemodialysis Complication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Jul 2025 (estimated)
- Primary completion
- 5 Nov 2025 (estimated)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 8 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 purpose of the study is to compare the effect of resistance exercise and aerobic exercise on intradialytic hypotension in patients undergoing hemodialysis.
Detailed description
Chronic kidney disease (CKD) is one of the leading causes of global morbidity and mortality. In the 2019 Global Burden of Disease study, CKD was among the top ten risks associated with the highest number of deaths worldwide, with a death toll of 3.16 million deaths.
Patients undergoing dialysis in Egypt in 2020 are mostly men (59%), and half of them are aged ≥55 years. Hypertension is the most common cause of end-stage kidney disease at 41%, followed by diabetes at 14%, whereas glomerulonephritis is the primary diagnosis in 3% of patients undergoing dialysis.
Hemodialysis (HD), continuous ambulatory peritoneal dialysis, and kidney transplantation are the three main modalities of renal replacement therapy. Hypotension is the most reported complication of routine outpatient HD treatments.
Toxic substances, also called uremic toxins, in the blood result in malaise, paraesthesia, mental impairment, peripheral circulatory disturbance, and muscle dysfunction.
While patients exercise during dialysis, those toxins move through the dialyzer with a large flux from the tissue to the vascular compartment. It results in increased muscle blood flow and opened capillary surface area. Besides, the intradialytic exercise showed not only better adoption and adherence but also a lower drop-out and greater compliance.
So, this study will investigate the effect of resistance and aerobic exercises on intradialytic hypotension in patients undergoing hemodialysis. thus, may affect the quality of life in chronic kidney disease dialysis patients. The results of this study may shed light on which of the selected exercises can decrease the risk of Intradialytic hypotension to help dialysis patients. To our knowledge, there are no previous similar studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medical therapy group | Active comparator | Other: HemodialysisPatients with chronic kidney disease will receive hemodialysis only, for four hours, 3 times per week. |
| intra-dialytic resistive exercise group | Experimental | Other: Hemodialysis, Other: Intradialytic resistive exercisePatients with chronic kidney disease will receive an intra-dialytic resistance exercise for 12 weeks (3 sessions/week) in addition to hemodialysis. |
| intra-dialytic aerobic exercise group | Experimental | Other: Hemodialysis, Other: Intradialytic aerobic exercisePatients with chronic kidney disease will receive an intra-dialytic aerobic exercise (leg pedaling) for 12 weeks (3 sessions/week) in addition to hemodialysis. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- End-stage renal disease (ESRD) or stage 5 chronic kidney disease (CKD) in which on maintenance regular HD (three sessions/week (on alternate days), for four hours/session for more than a year to five years when starting the study.
- Both gender male and female aged from 45 to 60 years old.
- Patients with intradialytic hypotension sudden drops of systolic pressure of more than 20 mm Hg or diastolic pressure of more than 10 mmHg.
- Receiving hemodialysis (HD) through uncomplicated arm arteriovenous (A-V) fistula.
- Patients with Body Mass Index (BMI): 18,5 < 30kg/m2.
Key exclusion criteria (11 listed)
- Severe Chest diseases (either obstructive or restrictive).
- Clinical signs of a severe cardiac event. (eg, severe atherosclerosis, congestive heart failure),
- Severe psychiatric or cognitive impairment, who unable to follow comment.
- Neurological disorders affecting respiratory muscles or any muscular dystrophies (cervical disc or bulge).
- Patients with severe self-limiting illness (e.g., cancer).
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 |
|---|---|---|
| HemodialysisThe participants receive hemodialysis for 4 hours, 3 times per week | Other | Medical therapy group, intra-dialytic aerobic exercise group, intra-dialytic resistive exercise group |
| Intradialytic resistive exerciseThe participants will receive intradialytic resistive exercise for 12 weeks (3 sessions/ week). Duration: 30 minutes during the first 2 hours of each dialysis session in a recumbent position or seated position. Time of session: The program starts with a warm-up phase which is 3:5 minutes in the form of light aerobic and stretching exercises for big muscles and ends with a cooling down phase which is 3:5 in the form of light aerobic exercise. The resistance exercises include exercises for the big muscles of only the Lower Limbs (LL) muscles of single and multiple-joint which are:1- Knee extensors, 2- Knee flexors, 3- Hip flexors, 4- Hip abductors and adductors. using sandbags of different weights. Sandbag weights are placed on the distal third of the tibia for LL exercises. Intensity: On the Borg's Scale of Perceived Exertion, which will be measured every 5 minutes during exercise. | Other | intra-dialytic resistive exercise group |
| Intradialytic aerobic exercisePatients with chronic kidney disease will receive an intradialytic aerobic exercise for 12 weeks (3 sessions/ week). Duration: 30 minutes during the first 2 hours of each dialysis session using a stationary bicycle ergometer in a supine position or seated position. Time of session: The warming up and the cooling down phase consists of 5:10 minutes of slow Pedaling. the main exercise phase consisted of 20 minutes of cycling. Intensity: The use of the Borg's Scale of Perceived Exertion (RPE) scale enables the intensity of the exercise to be adapted According to the tolerance of each patient. The use of the RPE scale enables the intensity of the exercise to be adapted According to the tolerance of each patient, the aim was to obtain between 11 light And 14 somewhat hard. | Other | intra-dialytic aerobic exercise group |
Primary outcome
Systolic blood pressure measurement
Time frame: 12 weeks
Blood pressure (BP) will be measured on the non-access arm using automatic BP cuffs attached to the patient's hemodialysis machine which is used routinely at each respective hemodialysis clinic. As well as for ankle brachial pressure index. Systolic blood pressure measurements will be taken pre-hemodialysis, at hemodialysis start (baseline), post-hemodialysis, and every 15 minutes during each dialysis session. BP measurements will be taken before selected exercise and after exercise.
Diastolic blood pressure measurement
Time frame: 12 weeks
Blood pressure (BP) will be measured on the non-access arm using automatic BP cuffs attached to the patient's hemodialysis machine which is used routinely at each respective hemodialysis clinic. As well as for ankle brachial pressure index. diastolic blood pressure measurements will be taken pre-hemodialysis, at hemodialysis start (baseline), post-hemodialysis, and every 15 minutes during each dialysis session. BP measurements will be taken before selected exercise and after exercise.
Ankle-Brachial Index (ABI)
Time frame: 12 weeks
This non-invasive test compares blood pressure in the ankles to blood pressure in the arms. An ABI below 0.9 usually suggests peripheral artery disease (PAD), a common cause of circulatory issues.
Peripheral oxygen saturation
Time frame: 12 weeks
Pulse oximetry is a non-invasive method used to measure the oxygen saturation level (SpO2) in the blood, providing an estimate of how much oxygen the hemoglobin in red blood cells is carrying. It provides data on oxygen delivery to extremities, which may be impaired in circulation issues. Normally, its value is 95-99%.
Creatinine level
Time frame: 12 weeks
Blood analysis will be used to measure creatinine level for all patients before and after intervention. Its values vary by sex; 0.6-1.2 mg/dl for men and 0.5-1.1 mg/dl for women.
blood urea level
Time frame: 12 weeks
Blood analysis will be used to measure blood urea for all patients before and after intervention. its normal value ranges from 17-43 mg/dl.
blood urea nitrogen test
Time frame: 12 weeks
Blood analysis will be used to measure blood urea nitrogen for all patients before and after intervention. its normal value ranges from 7-20 mg/dl.
serum albumin
Time frame: 12 weeks
Blood analysis will be used to measure serum albumin for all patients before and after intervention. its normal value in adults is typically 3.5-5.0 g/L.
2 secondary outcomes
Six minutes walking Test (6 MWT)
Time frame: 12 weeks
The Kidney Disease Quality of Life Short Form (KDQOL-SF)
Time frame: 12 weeks
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 8 Jul 2025.
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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.
Sahier El-Khashab, Professor study director
Cairo University
Nagwa Badr, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodialysis, Intradialytic resistive exercise and Intradialytic aerobic exercise in people with Hemodialysis Complication, 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 7 inclusion and 11 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: opening soon, as of the sponsor's last update on 8 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 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?
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 Yasmin Gouda, Master (20 10 08444667, yasmina200068guoda@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure measurement (time frame: 12 weeks). The study lists 8 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 8 Jul 2025.