Hemodialysis ComplicationNCT05722496
Difference Between Interval and Continous Intradialytic Exercise on Functional Capacity in Hemodialysis Patient
A study testing Aerobic pedaling exercise in people with Hemodialysis Complication, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this study is to find out the effect of interval versus continous intradialytic training on muscle quality index and functional capacity in Hemodialysis patients. The main question it aims to answer is: Does interval versus continous intradialytic training have an effect on muscle quality index and… Read more about this study
- Who is it for?
- Ages 45 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- Aerobic pedaling exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2023to 10 Sep 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 45 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 45- 55 years.
- Male sex included.
- Patients with grade 5 chronic renal failure on hemodialysis.
- Patients are on hemodialysis for 1-3 years.
- Body mass index (BMI) range from 25-34.9 Kg/m2.
- They will be medically and psychologically stable.
- Receiving their physician-prescribed pharmacotherapy regularly.
- Agree to participate by signing an informed consent form.
Who cannot join
- Inability to comprehend and follow instructions as in dementia or speech problems such as dysphasia.
- 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.
- Acute systemic infection.
- Presence of malignant disease.
- Patients with Diabetes Mellitus.
- Patients with Lupus Nephritis.
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- Patients with chronic obstructive lung disease, restrictive lung disease or chronic chest infection.
- Severe obesity (BMI > 35).
- Chronic inflammatory orthopedic disorders and rheumatoid arthritis.
- Patients with muscle injuries or neuromuscular disorders (muscular dystrophy, myasthenia gravis, myopathy, multiple sclerosis and peripheral neuropathy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interval Versus Continous Intradialytic Training on Muscla Quality Index and Functional Capacity in Hemodialysis Patients
The goal of this study is to find out the effect of interval versus continous intradialytic training on muscle quality index and functional capacity in Hemodialysis patients. The main question it aims to answer is:
Does interval versus continous intradialytic training have an effect on muscle quality index and functional capacity in hemodialysis patients? Patients will be assigned randomly by computerized block randomization into two groups:Group (A): 30 patients will participate in 8 weeks of aerobic exercise in the form of high intensity interval training (HIIT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week).Group (B): 30 patients will participate in 8 weeks of aerobic exercise in the form of moderate intensity continous training (MICT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week) . primary and secondary variables will be measured before starting treatment and after completion (after 2 months )
Read the detailed description
Individuals with CKD (both predialysis and ESRD) may be at greater risk of sarcopenia given the combined reductions in physical function, skeletal muscle performance and skeletal muscle mass.
Study include sixty male patients on hemodialysis for 1-3 years aged from 45 to 55 years old selected from hemodialysis unit at National Institute of Urology and Nephrology. Before starting treatment , patients will fill consent form and the study aims and procedure will be explained to each patient . study include Sixty male patients on hemodialysis for 1-3 years aged from 45 to 55 years old selected from hemodialysis unit at National Institute of Urology and Nephrology. Patients will be assigned randomly by computerized block randomization into two groups:Group (A): 30 patients will participate in 8 weeks of aerobic exercise in the form of high intensity interval training (HIIT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week).Group (B): 30 patients will participate in 8 weeks of aerobic exercise in the form of moderate intensity continous training (MICT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week) Karvonen formula will be used to calculate training heart rate THR= RHR+ (HRmax - RHR) 65%-80% AS HRmax = 220-Age patients of HIIT will perform aerobic exercise in the form of leg pedaling exercise in semi-supine position using leg ergometer at high intensity 85%-95% of HRpeak with 4 min of active breaks at an intensity of 60%-70% of HRpeak. . Exercise will be done at the first 2 hours of dialysis (to avoid dialysis hypotension episodes).
patients of MICT will perform aerobic exercise in the form of leg pedaling exercise in semi-supine position using leg ergometer at moderate intensity 50%-60% of HRpeak . Exercise will be done at the first 2 hours of dialysis (to avoid dialysis hypotension episodes).
primary and secondary variables will be measured before starting treatment and after completion (after 2 months )
- Conditions
- Hemodialysis Complication
- Being tested
- Aerobic pedaling exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic pedaling exerciseOther
aerobic exercise in the form of leg pedaling exercise in semi-supine position using leg ergometer by different intensities
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training Group (Group A) | Experimental | Each training session consist of three parts of 30 minutes:
* Warm up (5 minutes) free active exercise of the lower extremities,
* Training continued with three exercise intervals lasting 3 min each, at an exercise intensity of 85%-95% of HRpeak equalling 15-17 on the Borg scale. Each interval was separated by 4 min of active breaks at an intensity of 60%-70% of HRpeak.
* Cool down (5 minutes) free exercise of lower extremities. Training program will last for 8 weeks with frequency 3times / week. Receives: Other: Aerobic pedaling exercise |
| Moderate intensity continous training group (Group B) | Experimental | Each training session consist of three parts of 30 minutes:
* Warm up (5 minutes) free active exercise of the lower extremities,
* Training continued with cycling at low-to-moderate exercise intensity of 50%-60% of HRpeak, representing 11-13 on the Borg scale.
* Cool down (5 minutes) free exercise of lower extremities. Training program will last for 8 weeks with frequency 3times / week. Receives: Other: Aerobic pedaling exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle quality index
The MQI was quantified using a timed sit-to-stand test, body mass, and leg length to calculate a power index that is expressed in watts (W). The MQI was calculated as follows:
QI (Watts) = ((Leg length×0.4) ×Bodymass×gravity×10) ∕ Time taken for (sit to stand 5 times) Body mass will be measured using a digital scale. Leg length will be taken using tape measure to measure the distance (in meters) from the greater trochanter of the femur to the lateral malleolus, measured from standing position . BY using a stopwatch, sit-to-stand time will be calculated as the time to stand from a seated position and return to sitting consecutively five times. The use of arms not allowed during the sit-to-stand test. Acceleration of gravity (9.8 m/s2).
After measuring leg length, body mass and time for sit to stand, all these data will be written in the previous equation to calculate muscle quality index and expressed in watts (W).
Measured: 2 months
six minute walk test
Six minute walk test (6MWT) to assess physical functional capacity (using stopwatch, colored tape to mark starting line and end line of corridor) Using a stopwatch, assess physical functional capability. The 6MWT will be conducted indoors along a 30 m long, level, straight, enclosed hallway, with the length of the corridor indicated with brightly coloured tape at the beginning and end lines. Subjects will be advised to walk as far as possible from end to end of the corridor without jogging or running, and to cover as much distance as feasible in the 6 minute time limit . This test was performed at the beginning of treatment and at the end of treatment program (8 weeks) to assess functional performance difference.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start3 Jan 2023
- Primary completion10 Sep 2023
- Study completion10 Sep 2023
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
- Model description
- Patients will be assigned randomly by computerized block randomization into two groups:Group (A): 30 patients aged between 45 - 55 years old will participate in 8 weeks of aerobic exercise in the form of high intensity interval training (HIIT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week). Group (B): 30 patients aged between 45- 55 years old will participate in 8 weeks of aerobic exercise in the form of moderate intensity continous training (MICT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer Saber Mansour El-Sayed, Cairo University
- Investigators
- hala m ezz eldeen, professor, Study director, department of cardiovascular, respiratory and geriatrics disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722496
- Sponsor's protocol ID
- 111118
- Status last verified
- Sep 2023
- First submitted
- 23 Jan 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: after completion of the study and publication, data will be available for other researchers
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interval Versus Continous Intradialytic Training on Muscla Quality Index and Functional Capacity in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05722496
- Acronym / sponsor ID
- 111118
- Conditions
- Hemodialysis Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 10 Sep 2023 (actual)
- Study completion
- 10 Sep 2023 (actual)
- First posted
- 10 Feb 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.
The goal of this study is to find out the effect of interval versus continous intradialytic training on muscle quality index and functional capacity in Hemodialysis patients. The main question it aims to answer is:
Does interval versus continous intradialytic training have an effect on muscle quality index and functional capacity in hemodialysis patients? Patients will be assigned randomly by computerized block randomization into two groups:Group (A): 30 patients will participate in 8 weeks of aerobic exercise in the form of high intensity interval training (HIIT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week).Group (B): 30 patients will participate in 8 weeks of aerobic exercise in the form of moderate intensity continous training (MICT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week) . primary and secondary variables will be measured before starting treatment and after completion (after 2 months )
Detailed description
Individuals with CKD (both predialysis and ESRD) may be at greater risk of sarcopenia given the combined reductions in physical function, skeletal muscle performance and skeletal muscle mass.
Study include sixty male patients on hemodialysis for 1-3 years aged from 45 to 55 years old selected from hemodialysis unit at National Institute of Urology and Nephrology. Before starting treatment , patients will fill consent form and the study aims and procedure will be explained to each patient . study include Sixty male patients on hemodialysis for 1-3 years aged from 45 to 55 years old selected from hemodialysis unit at National Institute of Urology and Nephrology. Patients will be assigned randomly by computerized block randomization into two groups:Group (A): 30 patients will participate in 8 weeks of aerobic exercise in the form of high intensity interval training (HIIT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week).Group (B): 30 patients will participate in 8 weeks of aerobic exercise in the form of moderate intensity continous training (MICT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week) Karvonen formula will be used to calculate training heart rate THR= RHR+ (HRmax - RHR) 65%-80% AS HRmax = 220-Age patients of HIIT will perform aerobic exercise in the form of leg pedaling exercise in semi-supine position using leg ergometer at high intensity 85%-95% of HRpeak with 4 min of active breaks at an intensity of 60%-70% of HRpeak. . Exercise will be done at the first 2 hours of dialysis (to avoid dialysis hypotension episodes).
patients of MICT will perform aerobic exercise in the form of leg pedaling exercise in semi-supine position using leg ergometer at moderate intensity 50%-60% of HRpeak . Exercise will be done at the first 2 hours of dialysis (to avoid dialysis hypotension episodes).
primary and secondary variables will be measured before starting treatment and after completion (after 2 months )
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be assigned randomly by computerized block randomization into two groups:Group (A): 30 patients aged between 45 - 55 years old will participate in 8 weeks of aerobic exercise in the form of high intensity interval training (HIIT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week). Group (B): 30 patients aged between 45- 55 years old will participate in 8 weeks of aerobic exercise in the form of moderate intensity continous training (MICT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week).
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training Group (Group A) | Experimental | Other: Aerobic pedaling exerciseEach training session consist of three parts of 30 minutes: * Warm up (5 minutes) free active exercise of the lower extremities, * Training continued with three exercise intervals lasting 3 min each, at an exercise intensity of 85%-95% of HRpeak equalling 15-17 on the Borg scale. Each interval was separated by 4 min of active breaks at an intensity of 60%-70% of HRpeak. * Cool down (5 minutes) free exercise of lower extremities. Training program will last for 8 weeks with frequency 3times / week. |
| Moderate intensity continous training group (Group B) | Experimental | Other: Aerobic pedaling exerciseEach training session consist of three parts of 30 minutes: * Warm up (5 minutes) free active exercise of the lower extremities, * Training continued with cycling at low-to-moderate exercise intensity of 50%-60% of HRpeak, representing 11-13 on the Borg scale. * Cool down (5 minutes) free exercise of lower extremities. Training program will last for 8 weeks with frequency 3times / week. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age between 45- 55 years.
- Male sex included.
- Patients with grade 5 chronic renal failure on hemodialysis.
- Patients are on hemodialysis for 1-3 years.
- Body mass index (BMI) range from 25-34.9 Kg/m2.
Key exclusion criteria (10 listed)
- Inability to comprehend and follow instructions as in dementia or speech problems such as dysphasia.
- 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.
- Acute systemic infection.
- Presence of malignant disease.
- Patients with Diabetes Mellitus.
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 pedaling exerciseaerobic exercise in the form of leg pedaling exercise in semi-supine position using leg ergometer by different intensities | Other | High Intensity Interval Training Group (Group A), Moderate intensity continous training group (Group B) |
Primary outcome
muscle quality index
Time frame: 2 months
The MQI was quantified using a timed sit-to-stand test, body mass, and leg length to calculate a power index that is expressed in watts (W). The MQI was calculated as follows: QI (Watts) = ((Leg length×0.4) ×Bodymass×gravity×10) ∕ Time taken for (sit to stand 5 times) Body mass will be measured using a digital scale. Leg length will be taken using tape measure to measure the distance (in meters) from the greater trochanter of the femur to the lateral malleolus, measured from standing position . BY using a stopwatch, sit-to-stand time will be calculated as the time to stand from a seated position and return to sitting consecutively five times. The use of arms not allowed during the sit-to-stand test. Acceleration of gravity (9.8 m/s2). After measuring leg length, body mass and time for sit to stand, all these data will be written in the previous equation to calculate muscle quality index and expressed in watts (W).
six minute walk test
Time frame: 2 months
Six minute walk test (6MWT) to assess physical functional capacity (using stopwatch, colored tape to mark starting line and end line of corridor) Using a stopwatch, assess physical functional capability. The 6MWT will be conducted indoors along a 30 m long, level, straight, enclosed hallway, with the length of the corridor indicated with brightly coloured tape at the beginning and end lines. Subjects will be advised to walk as far as possible from end to end of the corridor without jogging or running, and to cover as much distance as feasible in the 6 minute time limit . This test was performed at the beginning of treatment and at the end of treatment program (8 weeks) to assess functional performance difference.
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 26 Sep 2023.
- Individual participant dataSharing planned: No. after completion of the study and publication, data will be available for other researchers
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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.
hala m ezz eldeen, professor study director
department of cardiovascular, respiratory and geriatrics disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic pedaling 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 8 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 26 Sep 2023. 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?
muscle quality index (time frame: 2 months). 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 26 Sep 2023.