Hemodialytic PatientsNCT07319468
Effect of Exercises on Hemodialysis
A study testing Aerobic exercises and Open kinetic chain active free range of motion in people with Hemodialytic Patients, run by Cairo University.
Trial summary
o Sixty-nine adult patients from both sexes. They were suffering from ESRD on maintenance hemodialysis, their age ranged from50-60 years old were selected from hemodialysis unit at Itay El Baroud central hospital. They were referred by the physician. Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Hemodialytic Patients
- What is being tested?
- Aerobic exercises and Open kinetic chain active free range of motion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Jun 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 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients were included according to the following criteria:
- Age between 50-60years.
- The patients had been on hemodialysis for at least 3 months with three sessions per week for 3-4hr per session.
- The patients were diagnosed with end stage renal failure (stage5 CKD) on maintenance regular HD (three sessions/week (on alternate days), for four hours/session) for more than three months. (Receiving HD through uncomplicated arm arteriovenous (A-V) fistula
- Under medical control
- Both men and women were enrolled
- Body math index ranged from 18,5- 24.9 kg/m²
Who cannot join
- Patients who experienced or had one or more of the following were excluded from the study:
- Patients with resting systolic blood pressure >200 mmHg and/or diastolic blood pressure >120 mmHg.
- patients with neurological problems (e.g. stroke, head injury)
- patients with musculoskeletal problems (e.g. sever osteoarthritis or difficulties in ambulation)
- Patients with uncontrolled pulmonary disease. (e.g. exaggerated chronic obstructive pulmonary disease, acute asthma)
- Patients with mental health problems and cognitive impairment due to inability to teach them how to make respiratory training.
Show all 11Show fewer
- Any patient who missed more than two weeks of the program or want to terminate the program.
- Severe obesity (BMI >35)
- Presence of malignant disease.
- Patients with unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure, acute pericarditis or myocarditis.
- The patients had hearing impairment or mental disorders.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Faten Mahmoud Eldesouky, Master in Physical Therapy contact
About this study
Official title: Effect of Intra Dialytic Aerobic Exercises Versus Active Free Exercises on Cognitive Function and Functional Capacity in Hemodialytic Patients
- Sixty-nine adult patients from both sexes. They were suffering from ESRD on maintenance hemodialysis, their age ranged from50-60 years old were selected from hemodialysis unit at Itay El Baroud central hospital. They were referred by the physician.
Read the detailed description
Ⅰ-Subjects:
- Sixty-nine adult patients from both sexes. They were suffering from ESRD on maintenance hemodialysis, their age ranged from50-60 years old were selected from hemodialysis unit at Itay El Baroud central hospital. They were referred by the physician.
Study group (A): the study group consisted of (23) patients who received aerobic exercise in form of (foot pedal exerciser) for 20 Minutes for each session, 3 sessions per week, for 8 weeks plus maintain on their medical treatment and hemodialysis.
Study group (B): the study group consisted of (23) who received active free range of motion exercise (open kinetic chain active free range of motion) for 20 minutes for each session, 3 sessions per week, for 8 weeks plus maintain on their medical treatment and hemodialysis.
Control group (C): the control group consisted of (23) patients who were maintained on their medical treatment and hemodialysis.
II- Instrumentation 6-Minutes walk test: The 6-min walk test (6MWT) is frequently used to measure physical function in transplanted patients.
- Fatigue Questionnaire (Fatigue Severity Scale) it was used to assess the level of fatigue.
- Laboratory investigation: urea and creatinine are commonly used to monitor the effects of exercise on urea clearance and kidney function improvement in transplant patients.
- The Mini-Cog test: is a quick, simple, and effective screening tool for early cognitive impairment in hemodialysis patients, making it ideal for busy clinical settings.
B-Therapeutic Equipment:
Foot pedal exerciser (fig.9):
- Simple horizontal foot pedal exerciser used during hemodialysis sessions.
- Dual pedals with non-slip straps for foot stability.
- Manual resistance adjustment via a single control knob (non-electric).
- Provides gradual increase in workload intensity.
- Compact and light weight design suitable for use while lying on the dialysis bed.
- Enables controlled, low-impact circular movement of the feet.
- Aims to improve circulation and strengthen lower limb muscles without requiring active sitting.
- Approximate device dimensions: 50 cm (length) x 40 cm (width) x 23 cm (height).
- Maximum recommended user weight: 70 kg. Participants completed the 30-min aerobic exercise sessions during the first 2 hrs. of each dialysis session, 3 times per week for 8 weeks, using a simulated bike riding. Patients will perform active free exercise for upper limb (the arm that hasn't shunt) and lower limbs. Each exercise session consisted of three phases: warm up, conditioning, and cool down.
- Conditions
- Hemodialytic Patients
- Being tested
- Aerobic exercises, Open kinetic chain active free range of motion, No intervention
- Keywords
- Aerobic Exercise, Chronic kidney disease, Hemodialysis, Functional Capacity
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercisesDevice
Foot pedal exerciser:
- Simple horizontal foot pedal exerciser used during hemodialysis sessions.
- Dual pedals with non-slip straps for foot stability.
- Manual resistance adjustment via a single control knob (non-electric).
- Provides gradual increase in workload intensity.
- Compact and light weight design suitable for use while lying on the dialysis bed.
- Enables controlled, low-impact circular movement of the feet.
- Aims to improve circulation and strengthen lower limb muscles without requiring active sitting.
- Approximate device dimensions: 50 cm (length) x 40 cm (width) x 23 cm (height).
- Maximum recommended user weight: 70 kg.
Open kinetic chain active free range of motionOther
Participants completed the 30-min aerobic exercise sessions during the first 2 hrs. of each dialysis session, 3 times per week for 8 weeks, using a simulated bike riding. Patients will perform active free exercise for upper limb (the arm that hasn't shunt) and lower limbs. Each exercise session consisted of three phases: warm up, conditioning, and cool down.
No interventionOther
the control group will receive only the standard medical care provided by dialysis center without any physical therapy intervention
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | (23) patients who received aerobic exercise in form of (foot pedal exerciser) for 20 Minutes for each session, 3 sessions per week, for 8 weeks. Receives: Device: Aerobic exercises |
| Active free range of motion exercise | Experimental | (23) patients who received active free range of motion exercise (open kinetic chain active free range of motion) for 20 minutes for each session, 3 sessions per week, for 8 weeks. Receives: Other: Open kinetic chain active free range of motion |
| control group | Other | (23) patients who will receive standard medical treatment for end-stage renal disease, including regular hemodialysis sessions and pharmacological management (e.g., Epoetin alfa and phosphate binders) as prescribed by their nephrologist, without participating in the physical therapy exercise program. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Questionnaire (Fatigue Severity Scale)
The Fatigue Severity Scale it used to assess the level of fatigue. The Fatigue Severity Scale scores range from 9 to 36 where higher scores indicate worse fatigue and lower scores indicate improvement in fatigue.
Measured: 8 weeks
6-Minutes walk test
The 6-min walk test (6MWT) is frequently used to measure physical function in transplanted patients
Measured: 8 weeks
Secondary outcomes (3)
Laboratory investigation (Urea analysis)
Urea analysis is commonly used to monitor the effects of exercise on urea clearance and kidney function
Measured: 8 weeks
The Mini-Cog test
The Mini-Cog test is a quick, simple, and effective screening tool for early cognitive impairment in hemodialysis patients, making it ideal for busy clinical settings. The Mini-Cog Test scores range from 0 to 5, where higher scores indicate better cognitive performance, and lower scores suggest potential cognitive impairment.
Measured: 8 weeks
Laboratory investigation (creatinine analysis)
creatinine analysis is used to be monitor the effects of exercise on creatinine clearance and kidney function
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialytic PatientsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faten Mahmoud, Cairo University
- Investigators
- Research Ethical Committee Cairo University, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319468
- Sponsor's protocol ID
- NO:P.T.R.EC/012/004902
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 6 Jan 2026
- 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 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intra Dialytic Aerobic Exercises Versus Active Free Exercises on Cognitive Function and Functional Capacity in Hemodialytic Patients
- ClinicalTrials.gov ID
- NCT07319468
- Acronym / sponsor ID
- NO:P.T.R.EC/012/004902
- Conditions
- Hemodialytic Patients
- Keywords
- Aerobic Exercise, Chronic kidney disease, Hemodialysis, Functional Capacity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 6 Jan 2026 (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.
- Sixty-nine adult patients from both sexes. They were suffering from ESRD on maintenance hemodialysis, their age ranged from50-60 years old were selected from hemodialysis unit at Itay El Baroud central hospital. They were referred by the physician.
Detailed description
Ⅰ-Subjects:
- Sixty-nine adult patients from both sexes. They were suffering from ESRD on maintenance hemodialysis, their age ranged from50-60 years old were selected from hemodialysis unit at Itay El Baroud central hospital. They were referred by the physician.
Study group (A): the study group consisted of (23) patients who received aerobic exercise in form of (foot pedal exerciser) for 20 Minutes for each session, 3 sessions per week, for 8 weeks plus maintain on their medical treatment and hemodialysis.
Study group (B): the study group consisted of (23) who received active free range of motion exercise (open kinetic chain active free range of motion) for 20 minutes for each session, 3 sessions per week, for 8 weeks plus maintain on their medical treatment and hemodialysis.
Control group (C): the control group consisted of (23) patients who were maintained on their medical treatment and hemodialysis.
II- Instrumentation 6-Minutes walk test: The 6-min walk test (6MWT) is frequently used to measure physical function in transplanted patients.
- Fatigue Questionnaire (Fatigue Severity Scale) it was used to assess the level of fatigue.
- Laboratory investigation: urea and creatinine are commonly used to monitor the effects of exercise on urea clearance and kidney function improvement in transplant patients.
- The Mini-Cog test: is a quick, simple, and effective screening tool for early cognitive impairment in hemodialysis patients, making it ideal for busy clinical settings.
B-Therapeutic Equipment:
Foot pedal exerciser (fig.9):
- Simple horizontal foot pedal exerciser used during hemodialysis sessions.
- Dual pedals with non-slip straps for foot stability.
- Manual resistance adjustment via a single control knob (non-electric).
- Provides gradual increase in workload intensity.
- Compact and light weight design suitable for use while lying on the dialysis bed.
- Enables controlled, low-impact circular movement of the feet.
- Aims to improve circulation and strengthen lower limb muscles without requiring active sitting.
- Approximate device dimensions: 50 cm (length) x 40 cm (width) x 23 cm (height).
- Maximum recommended user weight: 70 kg. Participants completed the 30-min aerobic exercise sessions during the first 2 hrs. of each dialysis session, 3 times per week for 8 weeks, using a simulated bike riding. Patients will perform active free exercise for upper limb (the arm that hasn't shunt) and lower limbs. Each exercise session consisted of three phases: warm up, conditioning, and cool down.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Device: Aerobic exercises(23) patients who received aerobic exercise in form of (foot pedal exerciser) for 20 Minutes for each session, 3 sessions per week, for 8 weeks. |
| Active free range of motion exercise | Experimental | Other: Open kinetic chain active free range of motion(23) patients who received active free range of motion exercise (open kinetic chain active free range of motion) for 20 minutes for each session, 3 sessions per week, for 8 weeks. |
| control group | Other | Other: No intervention(23) patients who will receive standard medical treatment for end-stage renal disease, including regular hemodialysis sessions and pharmacological management (e.g., Epoetin alfa and phosphate binders) as prescribed by their nephrologist, without participating in the physical therapy exercise program. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age between 50-60years.
- The patients had been on hemodialysis for at least 3 months with three sessions per week for 3-4hr per session.
- The patients were diagnosed with end stage renal failure (stage5 CKD) on maintenance regular HD (three sessions/week (on alternate days), for four hours/session) for more than three months. (Receiving HD through uncomplicated arm arteriovenous (A-V) fistula
- Under medical control
- Both men and women were enrolled
Key exclusion criteria (11 listed)
- Patients who experienced or had one or more of the following were excluded from the study:
- Patients with resting systolic blood pressure >200 mmHg and/or diastolic blood pressure >120 mmHg.
- patients with neurological problems (e.g. stroke, head injury)
- patients with musculoskeletal problems (e.g. sever osteoarthritis or difficulties in ambulation)
- Patients with uncontrolled pulmonary disease. (e.g. exaggerated chronic obstructive pulmonary disease, acute asthma)
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 exercisesFoot pedal exerciser: * Simple horizontal foot pedal exerciser used during hemodialysis sessions. * Dual pedals with non-slip straps for foot stability. * Manual resistance adjustment via a single control knob (non-electric). * Provides gradual increase in workload intensity. * Compact and light weight design suitable for use while lying on the dialysis bed. * Enables controlled, low-impact circular movement of the feet. * Aims to improve circulation and strengthen lower limb muscles without requiring active sitting. * Approximate device dimensions: 50 cm (length) x 40 cm (width) x 23 cm (height). * Maximum recommended user weight: 70 kg. | Device | Aerobic exercise |
| Open kinetic chain active free range of motionParticipants completed the 30-min aerobic exercise sessions during the first 2 hrs. of each dialysis session, 3 times per week for 8 weeks, using a simulated bike riding. Patients will perform active free exercise for upper limb (the arm that hasn't shunt) and lower limbs. Each exercise session consisted of three phases: warm up, conditioning, and cool down. | Other | Active free range of motion exercise |
| No interventionthe control group will receive only the standard medical care provided by dialysis center without any physical therapy intervention | Other | control group |
Primary outcome
Fatigue Questionnaire (Fatigue Severity Scale)
Time frame: 8 weeks
The Fatigue Severity Scale it used to assess the level of fatigue. The Fatigue Severity Scale scores range from 9 to 36 where higher scores indicate worse fatigue and lower scores indicate improvement in fatigue.
6-Minutes walk test
Time frame: 8 weeks
The 6-min walk test (6MWT) is frequently used to measure physical function in transplanted patients
3 secondary outcomes
Laboratory investigation (Urea analysis)
Time frame: 8 weeks
The Mini-Cog test
Time frame: 8 weeks
Laboratory investigation (creatinine analysis)
Time frame: 8 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 6 Jan 2026.
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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.
Faten Mahmoud Eldesouky, Master in Physical Therapy contact
Research Ethical Committee Cairo University principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercises and Open kinetic chain active free range of motion in people with Hemodialytic Patients, run by Cairo University.
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 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Faten Mahmoud Eldesouky, Master in Physical Therapy (01002618702 ext. 01002618702, fateneldesouky546@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Questionnaire (Fatigue Severity Scale) (time frame: 8 weeks). The study lists 2 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 6 Jan 2026.