Chronic Kidney DiseasesNCT06173141
Effect of Intradialytic Continuous Versus Interval Aerobic Exercises on Functional Capacity in Patients With Chronic Renal Failure.
A study testing low- to moderate-continuous intensity cycling exercises:, moderate- to high-interval intensity cycling exercises and hemodialysis sessions only in people with Chronic Kidney Diseases, run by Cairo University at 1 site in Egypt.
Trial summary
Chronic kidney disease has emerged as one of the leading causes of mortality worldwide, and it is one of a small number of non-communicable diseases that have shown an increase in associated deaths over the past 2 decades. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- low- to moderate-continuous intensity cycling exercises:, moderate- to high-interval intensity cycling exercises and hemodialysis sessions only
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2022to 30 Apr 2023
- 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 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sixty-seven patients of both sexes
- Age will range from 35-55 years old.
- BMI will be from 25-34.5 Kg/m2.
- All patients with stage 5 of CRF.
- All patients are stable on dialysis for at least six months before the study.
- Stable medical and clinical hemodynamic state.
Who cannot join
- 1. Patients with hearing impairment or mental disorder. 2. Patients with unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure, persistent systolic blood pressure (BP) greater than 200 mmHg, persistent diastolic BP greater than 120 mmHg, acute pericarditis or myocarditis.
- 3. Patients with auto-immune diseases. 4. Chronic inflammatory orthopedic disorders and rheumatoid arthritis. 5. Patients with history of neuromuscular disease (muscular dystrophy, myasthenia gravis, myopathy, multiple sclerosis and peripheral neuropathy).
- 6. Patients with chronic obstructive lung disease, restrictive lung disease or chronic chest infection.
- 7. Patients with BMI > 35Kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intradialytic Continuous Versus Interval Aerobic Exercises on Functional Capacity Quality of Life and in Patients With Chronic Renal Failure.
Chronic kidney disease has emerged as one of the leading causes of mortality worldwide, and it is one of a small number of non-communicable diseases that have shown an increase in associated deaths over the past 2 decades. The high number of affected individuals and the significant adverse impact of chronic kidney disease should prompt enhanced efforts for better prevention and treatment.
Chronic kidney disease is a serious medical problem, as it is associated with high risks of complications which lead to poor quality of life and physical capacity.
Read the detailed description
Sixty-seven patients undergoing haemodialysis randomly be allocated into three groups, (A, B \& C). Group A (low- to moderate-continuous intensity cycling exercises, group B (moderate- to high-interval intensity cycling exercises), the exercises performed two sessions per week for two months and group (C)Twenty three patients received the hemodialysis sessions only.
Group A (low- to moderate-continuous intensity cycling exercises:
Twenty three patients performed aerobic exercise during dialysis using Pedal machine at low- to moderate continuous intensity rating from 11 to 13 on the Borg scale for 15-30 minutes.
warming up and cool down (approximately 10 minutes) in form of free active exercise of the lower extremities.
Group B (moderate- to high-interval intensity cycling exercises), Twenty one patients performed aerobic exercise during dialysis using Pedal machine at moderate-to-high interval intensity rating from 12 to 15 on the Borg scale for 15-30 minutes.
warming up and cool down (approximately 10 minutes) in form of free active exercise of the lower extremities.
Inclusion Criteria:
- Sixty seven patients of both sexes
- Age will range from 35-55 years old.
- BMI will be from 25-34.5 Kg/m2.
- All patients with stage 5 of CRF.
- All patients are stable on dialysis for at least six months before the study.
- Stable medical and clinical hemodynamic state.
Exclusion criteria:
- Patients with hearing impairment or mental disorder.
- Patients with unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure, persistent systolic blood pressure (BP) greater than 200 mmHg, persistent diastolic BP greater than 120 mmHg, acute pericarditis or myocarditis.
- Patients with auto-immune diseases.
- Chronic inflammatory orthopedic disorders and rheumatoid arthritis.
- Patients with history of neuromuscular disease (muscular dystrophy, myasthenia gravis, myopathy, multiple sclerosis and peripheral neuropathy).
- Patients with chronic obstructive lung disease, restrictive lung disease or chronic chest infection.
- Patients with BMI > 35Kg/m2.
- Conditions
- Chronic Kidney Diseases
- Being tested
- low- to moderate-continuous intensity cycling exercises:, moderate- to high-interval intensity cycling exercises, hemodialysis sessions only
- Keywords
- Intradialytic cycling exercise, function capacity, hemodialysis, quality of life.
- 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.
low- to moderate-continuous intensity cycling exercises:Other
Also called low- to moderate-continuous aerobic exercise
aerobic exercise during dialysis using Pedal machine at low- to moderate continuous intensity rating from 11 to 13 on the Borg scale for 15-30 minutes.
warming up and cool down (approximately 10 minutes) in form of free active exercise of the lower extremities
moderate- to high-interval intensity cycling exercisesOther
aerobic exercise during dialysis using Pedal machine at moderate-to-high interval intensity rating from 12 to 15 on the Borg scale for 15-30 minutes.
warming up and cool down (approximately 10 minutes) in form of free active exercise of the lower extremities
hemodialysis sessions onlyOther
hemodialysis sessions only
| Study group | Role | What they receive |
|---|---|---|
| Group A (low- to moderate-continuous intensity cycling exercises: | Active comparator | Patients performed aerobic exercise during dialysis using Pedal machine at low- to moderate continuous intensity rating from 11 to 13 on the Borg scale for 15-30 minutes.
warming up and cool down (approximately 10 minutes) in form of free active exercise of the lower extremities Receives: Other: low- to moderate-continuous intensity cycling exercises: |
| Group B (moderate- to high-interval intensity cycling exercises), | Active comparator | Patients performed aerobic exercise during dialysis using Pedal machine at moderate-to-high interval intensity rating from 12 to 15 on the Borg scale for 15-30 minutes.
warming up and cool down (approximately 10 minutes) in form of free active exercise of the lower extremities Receives: Other: moderate- to high-interval intensity cycling exercises |
| group (C) | Sham comparator | received the hemodialysis sessions only. Receives: Other: hemodialysis sessions only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney Disease Quality of Life Questionnaire -SF36(KDQoL-SF36)
The KDQOL™-36 contains 5 subscales: The Physical Component Summary (PCS), Mental Component Summary (MCS), Burden of Kidney Disease (BKD), Symptoms and Problems of Kidney Disease (SPKD), and Effects of Kidney Disease (EKD). The first 2 subscales are a generic measure of HRQOL (and are identical to the SF-12), whereas the last 3 assess issues specific to patients with ESRD or earlier stages of chronic kidney disease.
Measured: pre and post treatment after 2 months
Secondary outcomes (2)
blood urea, serum creatinine
Blood samples are drawn from the arterial side of the hemodialysis access immediately prior to hemodialysis. Blood sample must be drawn before dialysis is started to prevent this sample from reflecting any impact of dialysis. pre and post kitz blood samples were sent to benha university hospital laboratory for estimating blood urea and creatinine.
Measured: pre and post treatment after 2 months
6-min walk distance
6min walk test carried out before and after the intervention to determine patient physical functional capacity. According to the American Thoracic Society ,Guidelines for the Six-Minute Walk Test (ATS .2002).
Measured: pre and post treatment after 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start30 Apr 2022
- Primary completion30 Oct 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies 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
- Sixty-seven patients undergoing haemodialysis randomly be allocated into three groups, (A, B \& C). Group A (low- to moderate-continuous intensity cycling exercises, group B (moderate- to high-interval intensity cycling exercises), the exercises performed two sessions per week for two months and group (C) received the hemodialysis sessions only.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Ahmed Mousa Galeb, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173141
- Sponsor's protocol ID
- Chronic renal failure
- Status last verified
- May 2025
- First submitted
- 7 Dec 2023
- Last updated
- 21 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pei G, Tang Y, Tan L, Tan J, Ge L, Qin W. Aerobic exercise in adults with chronic kidney disease (CKD): a meta-analysis. Int Urol Nephrol. 2019 Oct;51(10):1787-1795. doi: 10.1007/s11255-019-02234-x. Epub 2019 Jul 22.
PubMed 31332699Wulczyn KE, Zhao SH, Rhee EP, Kalim S, Shafi T. Trajectories of Uremic Symptom Severity and Kidney Function in Patients with Chronic Kidney Disease. Clin J Am Soc Nephrol. 2022 Apr;17(4):496-506. doi: 10.2215/CJN.13010921. Epub 2022 Mar 4.
PubMed 35246460
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intradialytic Continuous Versus Interval Aerobic Exercises on Functional Capacity Quality of Life and in Patients With Chronic Renal Failure.
- ClinicalTrials.gov ID
- NCT06173141
- Acronym / sponsor ID
- Chronic renal failure
- Conditions
- Chronic Kidney Diseases
- Keywords
- Intradialytic cycling exercise, function capacity, hemodialysis, quality of life.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 15 Dec 2023 (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.
Chronic kidney disease has emerged as one of the leading causes of mortality worldwide, and it is one of a small number of non-communicable diseases that have shown an increase in associated deaths over the past 2 decades. The high number of affected individuals and the significant adverse impact of chronic kidney disease should prompt enhanced efforts for better prevention and treatment.
Chronic kidney disease is a serious medical problem, as it is associated with high risks of complications which lead to poor quality of life and physical capacity.
Detailed description
Sixty-seven patients undergoing haemodialysis randomly be allocated into three groups, (A, B \& C). Group A (low- to moderate-continuous intensity cycling exercises, group B (moderate- to high-interval intensity cycling exercises), the exercises performed two sessions per week for two months and group (C)Twenty three patients received the hemodialysis sessions only.
Group A (low- to moderate-continuous intensity cycling exercises:
Twenty three patients performed aerobic exercise during dialysis using Pedal machine at low- to moderate continuous intensity rating from 11 to 13 on the Borg scale for 15-30 minutes.
warming up and cool down (approximately 10 minutes) in form of free active exercise of the lower extremities.
Group B (moderate- to high-interval intensity cycling exercises), Twenty one patients performed aerobic exercise during dialysis using Pedal machine at moderate-to-high interval intensity rating from 12 to 15 on the Borg scale for 15-30 minutes.
warming up and cool down (approximately 10 minutes) in form of free active exercise of the lower extremities.
Inclusion Criteria:
- Sixty seven patients of both sexes
- Age will range from 35-55 years old.
- BMI will be from 25-34.5 Kg/m2.
- All patients with stage 5 of CRF.
- All patients are stable on dialysis for at least six months before the study.
- Stable medical and clinical hemodynamic state.
Exclusion criteria:
- Patients with hearing impairment or mental disorder.
- Patients with unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure, persistent systolic blood pressure (BP) greater than 200 mmHg, persistent diastolic BP greater than 120 mmHg, acute pericarditis or myocarditis.
- Patients with auto-immune diseases.
- Chronic inflammatory orthopedic disorders and rheumatoid arthritis.
- Patients with history of neuromuscular disease (muscular dystrophy, myasthenia gravis, myopathy, multiple sclerosis and peripheral neuropathy).
- Patients with chronic obstructive lung disease, restrictive lung disease or chronic chest infection.
- Patients with BMI > 35Kg/m2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Sixty-seven patients undergoing haemodialysis randomly be allocated into three groups, (A, B \& C). Group A (low- to moderate-continuous intensity cycling exercises, group B (moderate- to high-interval intensity cycling exercises), the exercises performed two sessions per week for two months and group (C) received the hemodialysis sessions only.
| Arm | Type | Receives |
|---|---|---|
| Group A (low- to moderate-continuous intensity cycling exercises: | Active comparator | Other: low- to moderate-continuous intensity cycling exercises:Patients performed aerobic exercise during dialysis using Pedal machine at low- to moderate continuous intensity rating from 11 to 13 on the Borg scale for 15-30 minutes. warming up and cool down (approximately 10 minutes) in form of free active exercise of the lower extremities |
| Group B (moderate- to high-interval intensity cycling exercises), | Active comparator | Other: moderate- to high-interval intensity cycling exercisesPatients performed aerobic exercise during dialysis using Pedal machine at moderate-to-high interval intensity rating from 12 to 15 on the Borg scale for 15-30 minutes. warming up and cool down (approximately 10 minutes) in form of free active exercise of the lower extremities |
| group (C) | Sham comparator | Other: hemodialysis sessions onlyreceived the hemodialysis sessions only. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Sixty-seven patients of both sexes
- Age will range from 35-55 years old.
- BMI will be from 25-34.5 Kg/m2.
- All patients with stage 5 of CRF.
- All patients are stable on dialysis for at least six months before the study.
Key exclusion criteria (4 listed)
- 1. Patients with hearing impairment or mental disorder. 2. Patients with unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure, persistent systolic blood pressure (BP) greater than 200 mmHg, persistent diastolic BP greater than 120 mmHg, acute pericarditis or myocarditis.
- 3. Patients with auto-immune diseases. 4. Chronic inflammatory orthopedic disorders and rheumatoid arthritis. 5. Patients with history of neuromuscular disease (muscular dystrophy, myasthenia gravis, myopathy, multiple sclerosis and peripheral neuropathy).
- 6. Patients with chronic obstructive lung disease, restrictive lung disease or chronic chest infection.
- 7. Patients with BMI > 35Kg/m2.
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 |
|---|---|---|
| low- to moderate-continuous intensity cycling exercises:Also: low- to moderate-continuous aerobic exerciseaerobic exercise during dialysis using Pedal machine at low- to moderate continuous intensity rating from 11 to 13 on the Borg scale for 15-30 minutes. warming up and cool down (approximately 10 minutes) in form of free active exercise of the lower extremities | Other | Group A (low- to moderate-continuous intensity cycling exercises: |
| moderate- to high-interval intensity cycling exercisesaerobic exercise during dialysis using Pedal machine at moderate-to-high interval intensity rating from 12 to 15 on the Borg scale for 15-30 minutes. warming up and cool down (approximately 10 minutes) in form of free active exercise of the lower extremities | Other | Group B (moderate- to high-interval intensity cycling exercises), |
| hemodialysis sessions onlyhemodialysis sessions only | Other | group (C) |
Primary outcome
Kidney Disease Quality of Life Questionnaire -SF36(KDQoL-SF36)
Time frame: pre and post treatment after 2 months
The KDQOL™-36 contains 5 subscales: The Physical Component Summary (PCS), Mental Component Summary (MCS), Burden of Kidney Disease (BKD), Symptoms and Problems of Kidney Disease (SPKD), and Effects of Kidney Disease (EKD). The first 2 subscales are a generic measure of HRQOL (and are identical to the SF-12), whereas the last 3 assess issues specific to patients with ESRD or earlier stages of chronic kidney disease.
2 secondary outcomes
blood urea, serum creatinine
Time frame: pre and post treatment after 2 months
6-min walk distance
Time frame: pre and post treatment after 2 months
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 21 May 2025.
- Background: PubMed 31332699Pei G, Tang Y, Tan L, Tan J, Ge L, Qin W. Aerobic exercise in adults with chronic kidney disease (CKD): a meta-analysis. Int Urol Nephrol. 2019 Oct;51(10):1787-1795. doi: 10.1007/s11255-019-02234-x. Epub 2019 Jul 22.
- Background: PubMed 35246460Wulczyn KE, Zhao SH, Rhee EP, Kalim S, Shafi T. Trajectories of Uremic Symptom Severity and Kidney Function in Patients with Chronic Kidney Disease. Clin J Am Soc Nephrol. 2022 Apr;17(4):496-506. doi: 10.2215/CJN.13010921. Epub 2022 Mar 4.
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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. 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 low- to moderate-continuous intensity cycling exercises:, moderate- to high-interval intensity cycling exercises and hemodialysis sessions only in people with Chronic Kidney Diseases, 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 4 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 21 May 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. Some participants in this study may receive a placebo. 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?
Kidney Disease Quality of Life Questionnaire -SF36(KDQoL-SF36) (time frame: pre and post treatment after 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06173141, which also lists 2 linked publications.
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 21 May 2025.