HemodialysisNCT06838299
Two Different Renal Rehabilitation Protocols in Hemodialysis Patients
A study testing aerobic exercise, resistance exercise and standard medical treatment in people with Hemodialysis, run by Beni-Suef University at 1 site in Egypt.
Trial summary
This clinical trial will investigate how two different intradialytic exercise programs affect health in older adults with chronic kidney disease receiving regular hemodialysis. One group will perform aerobic exercise (cycling) combined with inspiratory muscle training, another group will perform resistance (strength)… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- aerobic exercise, resistance exercise and standard medical treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Feb 2025to 28 Aug 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients from both gender
- With chronic kidney disease
- Unemployed living a sedentary lifestyle
- Receive regular hemodialysis sessions at 3months ago
- All of them have vascular access through arteriovenous fistula
- Age range over 60years
- Fully understand purpose and procedure of study
- Stable and have sufficient level of cognition and ability to understand instructions
Who cannot join
- • Real difficulties with understanding and signing The written informed consent
- Recent sequela of cerebrovascular accidents
- Osteoarticular or musculoskeletal diseases
- Un controlled systemic hypertension
- Un controlled diabetes
- Un stable angina
Show all 12Show fewer
- Fever
- Infectious disease
- Acute respiratory failure
- Recent acute myocardial infarction
- Smoking
- Peripheral vascular alterations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Two Different Renal Rehabilitation Protocols on Respiratory and Peripheral Muscles Strength in Hemodialysis Patients
This clinical trial will investigate how two different intradialytic exercise programs affect health in older adults with chronic kidney disease receiving regular hemodialysis. One group will perform aerobic exercise (cycling) combined with inspiratory muscle training, another group will perform resistance (strength) exercises combined with inspiratory muscle training, and a third control group will receive standard medical care without structured exercise. Men and women over 60 years of age on regular hemodialysis will be recruited from the kidney dialysis department and will exercise three times per week for three months.
Read the detailed description
Here is a fully cleaned and language-checked version of your protocol text, with all in-text bibliographic citations removed and spelling/grammar smoothed while preserving your meaning.
Type of study: Randomized controlled trial
This study is a prospective interventional randomized controlled trial that will be conducted on ninety chronic kidney disease (CKD) patients on regular hemodialysis of both sexes aged over sixty years. They will be recruited from the kidney dialysis department and randomly divided into three equal groups:
Intervention group 1: Includes 30 CKD patients on hemodialysis who will receive aerobic exercise, inspiratory muscle training and medical treatment.
Intervention group 2: Includes 30 CKD patients on hemodialysis who will receive resistance exercise, inspiratory muscle training and medical treatment.
Control group: Includes 30 CKD patients on hemodialysis who will receive medical treatment only.
Instrumentation Evaluation will be done before and after treatment and at follow-up after 3 months and 6 months from the beginning of treatment.
- Evaluation equipment Maximum inspiratory pressure meter (CareFusion UK, model 2321td).
Kidney Disease and Quality of Life questionnaire (KDQOL-SF™ 1.3).
Peak oxygen consumption (predicted peak VO₂).
Six-minute walk test (6MWT).
Modified Borg scale (assesses the sensation of dyspnea and lower limb fatigue during walking).
Echocardiogram to detect left ventricular ejection fraction.
One-repetition maximum (1RM).
Laboratory analysis: glomerular filtration rate (GFR), serum creatinine, blood urea and blood urea nitrogen (BUN).
- Training equipment Inspiratory muscle trainer (Threshold® Inspiratory Muscle Trainer, calibrated spring-loaded valve with adjustable pressure from 7 to 41 cmH₂O).
Bicycle ergometer.
Weights (sandbags).
Evaluation procedures
Maximum inspiratory pressure meter (MIP):
Used to determine inspiratory muscle strength before and after training. The patient will be instructed to insert the mouthpiece into the mouth, ensuring the flange is positioned over the gums and inside the lips, while the bite blocks are between the teeth. The subject will exhale to residual volume, then perform a forced inhalation against the mouthpiece with maximal effort for at least 2 seconds. Measurements will be taken while the participant is seated in a reclining chair (hips and knees at 90°) in the hemodialysis room at the beginning of the hemodialysis session.
Kidney Disease and Quality of Life questionnaire (KDQOL-SF / KDQOL-36):
The KDQOL-36 is a short version of the KDQOL-SF that includes only 36 questions. The survey can usually be completed in 3-5 minutes, which saves time and resources in large-scale population surveys. Each subscale score ranges between 0 and 100, with higher values indicating better health.
Predicted peak VO₂:
Predicted peak VO₂ will be calculated using the Cahalin equation:
Peak VO₂
= 0.03
× distance in meters
+ 3.98 Peak VO₂=0.03×distance in meters+3.98, where the distance in meters is taken from the 6-minute walk test.
Six-minute walk test (6MWT):
Used to detect functional capacity. The test will be carried out along a 30-meter corridor, with tape placed every 2 meters. Patients will be instructed to walk the longest possible distance in 6 minutes continuously, turning around at the end marker without stopping. They will be instructed to walk as far as they can for 6 minutes without running or jogging. The total distance covered in meters will be recorded at the end of the test for analysis.
Modified Borg scale:
Used to assess the sensation of dyspnea and fatigue during exercise.
One-repetition maximum (1RM):
Used to determine the maximum load that can be lifted once with proper form for the quadriceps and hamstrings, and to prescribe and adjust resistance training loads.
Laboratory analysis:
GFR, serum creatinine, blood urea and BUN will be measured according to standard laboratory procedures.
Additional clinical and anthropometric measures:
Heart rate, blood pressure, oxygen saturation, weight, height and BMI will be assessed as part of medical and safety monitoring. Dialysis duration and dialysis vintage (time on dialysis) will also be recorded.
Treatment procedures Training will be applied for 3 months, three sessions per week, intradialysis during the first two hours of the hemodialysis session.
- Inspiratory muscle training (groups A and B) Inspiratory muscle training will be performed at 60% of maximal inspiratory pressure for 30 minutes per session, 3 days a week, for 3 months. Each patient will breathe through an individual mouthpiece. The resistance will be set at 60% of the maximum inspiratory pressure measured by the maximum inspiratory pressure meter and marked on the training device. A single training session will consist of five sets, each containing five inspirations (total 25 breaths) with one minute of recovery between sets. The resistance will be adjusted every week to remain at 60% of the newly measured maximum inspiratory pressure; if the value remains unchanged, the patient will continue training at the previous week's level.
- Aerobic exercise (group A) Patients in group 1 will perform intradialytic aerobic exercise on a stationary bicycle ergometer. A 5-minute warm-up before exercise and a 5-minute cool-down after exercise at 30-40% of maximum heart rate will be carried out each session. The main aerobic training phase will consist of 20 minutes of cycling at moderate intensity (approximately 70-80% of maximum heart rate). Training will be performed in the first half of the dialysis session over a 3-month period, three sessions per week. Patients will use a stationary bicycle ergometer in the supine or semi-recumbent position for a minimum of 30 minutes per hemodialysis session, and speed, load and duration will be gradually increased according to patient performance and tolerance. Training loads will be adjusted based on clinical response and perceived exertion.
- Resistance exercise (group B) Patients in group 2 will perform dynamic closed-chain and open-chain resistance exercises targeting the quadriceps and hamstring muscles. Training will start at 50% of the initial 1RM with 5 repetitions for each exercise. It will then be progressed to three sets of 8 repetitions at 70% of 1RM, guided by the patient's Borg scale rating of exertion. Training loads will be increased when patients can comfortably complete three sets with good form. The training resistance will be adjusted according to newly measured 1RM values.
- Control group (group C) Patients in the control group will receive medical treatment and standard hemodialysis care only, with no structured intradialytic exercise program. They will undergo the same schedule of assessments as the intervention groups.
Purpose of the study
The purpose of this study is to evaluate the effect of:
Combined inspiratory muscle training with aerobic exercise (group 1), and
Combined inspiratory muscle training with resistance exercise (group 2),
compared with medical treatment alone (control group), in hemodialysis CKD patients with respect to the following outcomes:
Medical status of the patient (heart rate, blood pressure, oxygen saturation).
Laboratory analysis (GFR, serum creatinine, blood urea and BUN).
Inspiratory muscle pressure (MIP).
Dialysis period and duration.
Weight, height and BMI.
Quality of life (KDQOL questionnaire).
Modified Borg scale scores (dyspnea and fatigue).
- Conditions
- Hemodialysis
- Being tested
- aerobic exercise, resistance exercise, standard medical treatment, inspiratory muscle training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseDevice
Aerobic exercise: by bicycle ergomete 5-minute warm-up before exercise and a 5-minute cool-down following exercise at intensity (40-65%HR max) were carried out each time. In addition, the exercise was performed in the first half of the dialysis session over a 3 months period for 3 sessions a week
resistance exerciseDevice
Dynamic closed- and open-chain resistance exercises performed by the patients' quadriceps and hamstring muscles. Patients started at 50% of their initial one-repetition maximum (1-RM) with 5 repetitions for each exercise and later progressed to three sets of 8 repetitions at 70% of their 1-RM according to the patient's Borg scale of exertion; training loads were increased when patients could comfortably complete three sets with good form.
standard medical treatmentOther
standard medical treatment
inspiratory muscle trainingDevice
Inspiratory muscle training at 60% of maximal inspiratory pressure for 30 minutes/session, 3 days a week, for 3 months Each patient breathes through a separate mouthpiece. The resistance is adjusted at 60% of the maximum inspiratory pressure detected from the maximum inspiratory pressure meter and is marked on the training device. A single training session consists of five sets, each containing five inspirations, with a total of twenty-five breaths with one minute of recovery between each set. The resistance was adjusted every week to be 60% of the new maximum inspiratory pressure and if it remained the same, the subject continued to train at the level of the previous week.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise plus inspiratory muscle training (group A) | Active comparator | I)inspiratory muscle training:
Inspiratory muscle training at 60% of maximal inspiratory pressure for 30 minutes/ session, 3 days a week, for 3 months Each patient breathes through a separate mouthpiece. The resistance is adjusted at 60% of maximum inspiratory pressure detected from maximum inspiratory pressure meter and is marked on the training device. A single training session consists of five sets, each contains five inspirations with total of twenty five breaths with one minute of recovery between each set. The resistance was adjusted every week to be 60% of the new maximum inspiratory pressure and if it remained the same, the subject continued to train at the level of the previous week
Aerobic exercise:
5-minute warm-up before exercise and a 5-minute cool-down following exercise at intensity (40-65%HR reserve) were carried out each time. In addition, the exercise was performed in the first half of the dialysis session over a 3 months period for 3 sessions per week . Receives: Device: aerobic exercise; Other: standard medical treatment; Device: inspiratory muscle training |
| Resistance exercise plus inspiratory muscle training (group B) | Active comparator | Resistance exercise:
Dynamic closed- and open-chain resistance exercises performed by the patients quadriceps and hamstrings muscles . Patients started at 50% of their initial one-repetition maximum (1-RM) with 5 repetitions for each exercise and later progressed to three sets of 8 repetitions at 70% of their 1-RM according to the patient Borg scale of exertion; training loads were increased when patients could comfortably complete three sets with good form.
inspiratory muscle training: Inspiratory muscle training at 60% of maximal inspiratory pressure for 30 minutes/ session, 3 days a week, for 3 months Each patient breathes through a separate mouthpiece. The resistance is adjusted at 60% of maximum inspiratory pressure detected from maximum inspiratory pressure meter and is marked on the training device. A single training session consists of five sets, each contains five inspirations with total of twenty five breaths with one minute of recovery between each set. Receives: Device: resistance exercise; Other: standard medical treatment; Device: inspiratory muscle training |
| group C (control group) | Active comparator | in this group there is no exercise ,patients have assessment pre and post 3 months and follow up Receives: Other: standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
6minute walk test
-6 minute walk test : to detect functional capacity , carry out in a 30 meters line along the passage way , the tape is placed every 2 meter . patients are instructed to walk the longest possible distance in 6 minutes continuously and turning around at the final mark without stopping .they are instructed to walk as far as they can for 6 minutes without running or jogging .covered distance in meters is measured at the end of analysis.
Measured: Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)
Maximum inspiratory pressure
-Maximum inspiratory pressure : to determine the inspiratory muscle strength before and after training. the patient will be instructed to insert the mouthpiece into the mouth, ensuring the flange is positioned over the gums and inside the lips, while the 'bite blocks' are between the teeth. The subject should then exhale to RV (Residual Volume), then perform a forced inhalation against the mouthpiece with as much effort as possible for as long as possible (minimum 2 seconds). while the participants were seated in a reclining chair (with knees and hips at 90) in a HD room at the beginning of the HD session .
Measured: Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)
Secondary outcomes (6)
Kidney Disease & Quality of Life (KDQOL-SF36)
KDQOL-36 is an abbreviated form of KDQOL-SF, with solely thirty-six questions.The survey can be conducted in 3-5 minutes, thereby conserving both time \& resources in extensive population surveys. Each subscale score varies from 0 to 100, with higher values indicating improved health
Measured: Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)
peak vo2
Predicted peak VO2 using the Cahalin equation: Peak VO2 = 0.03 × distance in meters + 3.98, determined by measuring the walking distance from the 6-Minute Walk Test
Measured: Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)
modified Borg scale
It assess The sensation of dyspnea, fatigue of lower limbs during walk
Measured: Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)
creatinine
ab analysis for kidney function
Measured: Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)
GFR
lab analysis for kidney function
Measured: Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)
KT/V
lab analysis for kidney function
Measured: Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start28 Feb 2025
- Primary completion28 May 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Atta Ahmed, Beni-Suef University
- Investigators
- Sherine H Mehani, professor, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838299
- Sponsor's protocol ID
- hemodialysis
- Status last verified
- Mar 2026
- First submitted
- 16 Feb 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rhee et al,2019
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Two Different Renal Rehabilitation Protocols on Respiratory and Peripheral Muscles Strength in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06838299
- Acronym / sponsor ID
- hemodialysis
- Conditions
- Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 20 Feb 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.
This clinical trial will investigate how two different intradialytic exercise programs affect health in older adults with chronic kidney disease receiving regular hemodialysis. One group will perform aerobic exercise (cycling) combined with inspiratory muscle training, another group will perform resistance (strength) exercises combined with inspiratory muscle training, and a third control group will receive standard medical care without structured exercise. Men and women over 60 years of age on regular hemodialysis will be recruited from the kidney dialysis department and will exercise three times per week for three months.
Detailed description
Here is a fully cleaned and language-checked version of your protocol text, with all in-text bibliographic citations removed and spelling/grammar smoothed while preserving your meaning.
Type of study: Randomized controlled trial
This study is a prospective interventional randomized controlled trial that will be conducted on ninety chronic kidney disease (CKD) patients on regular hemodialysis of both sexes aged over sixty years. They will be recruited from the kidney dialysis department and randomly divided into three equal groups:
Intervention group 1: Includes 30 CKD patients on hemodialysis who will receive aerobic exercise, inspiratory muscle training and medical treatment.
Intervention group 2: Includes 30 CKD patients on hemodialysis who will receive resistance exercise, inspiratory muscle training and medical treatment.
Control group: Includes 30 CKD patients on hemodialysis who will receive medical treatment only.
Instrumentation Evaluation will be done before and after treatment and at follow-up after 3 months and 6 months from the beginning of treatment.
- Evaluation equipment Maximum inspiratory pressure meter (CareFusion UK, model 2321td).
Kidney Disease and Quality of Life questionnaire (KDQOL-SF™ 1.3).
Peak oxygen consumption (predicted peak VO₂).
Six-minute walk test (6MWT).
Modified Borg scale (assesses the sensation of dyspnea and lower limb fatigue during walking).
Echocardiogram to detect left ventricular ejection fraction.
One-repetition maximum (1RM).
Laboratory analysis: glomerular filtration rate (GFR), serum creatinine, blood urea and blood urea nitrogen (BUN).
- Training equipment Inspiratory muscle trainer (Threshold® Inspiratory Muscle Trainer, calibrated spring-loaded valve with adjustable pressure from 7 to 41 cmH₂O).
Bicycle ergometer.
Weights (sandbags).
Evaluation procedures
Maximum inspiratory pressure meter (MIP):
Used to determine inspiratory muscle strength before and after training. The patient will be instructed to insert the mouthpiece into the mouth, ensuring the flange is positioned over the gums and inside the lips, while the bite blocks are between the teeth. The subject will exhale to residual volume, then perform a forced inhalation against the mouthpiece with maximal effort for at least 2 seconds. Measurements will be taken while the participant is seated in a reclining chair (hips and knees at 90°) in the hemodialysis room at the beginning of the hemodialysis session.
Kidney Disease and Quality of Life questionnaire (KDQOL-SF / KDQOL-36):
The KDQOL-36 is a short version of the KDQOL-SF that includes only 36 questions. The survey can usually be completed in 3-5 minutes, which saves time and resources in large-scale population surveys. Each subscale score ranges between 0 and 100, with higher values indicating better health.
Predicted peak VO₂:
Predicted peak VO₂ will be calculated using the Cahalin equation:
Peak VO₂
= 0.03
× distance in meters
+ 3.98 Peak VO₂=0.03×distance in meters+3.98, where the distance in meters is taken from the 6-minute walk test.
Six-minute walk test (6MWT):
Used to detect functional capacity. The test will be carried out along a 30-meter corridor, with tape placed every 2 meters. Patients will be instructed to walk the longest possible distance in 6 minutes continuously, turning around at the end marker without stopping. They will be instructed to walk as far as they can for 6 minutes without running or jogging. The total distance covered in meters will be recorded at the end of the test for analysis.
Modified Borg scale:
Used to assess the sensation of dyspnea and fatigue during exercise.
One-repetition maximum (1RM):
Used to determine the maximum load that can be lifted once with proper form for the quadriceps and hamstrings, and to prescribe and adjust resistance training loads.
Laboratory analysis:
GFR, serum creatinine, blood urea and BUN will be measured according to standard laboratory procedures.
Additional clinical and anthropometric measures:
Heart rate, blood pressure, oxygen saturation, weight, height and BMI will be assessed as part of medical and safety monitoring. Dialysis duration and dialysis vintage (time on dialysis) will also be recorded.
Treatment procedures Training will be applied for 3 months, three sessions per week, intradialysis during the first two hours of the hemodialysis session.
- Inspiratory muscle training (groups A and B) Inspiratory muscle training will be performed at 60% of maximal inspiratory pressure for 30 minutes per session, 3 days a week, for 3 months. Each patient will breathe through an individual mouthpiece. The resistance will be set at 60% of the maximum inspiratory pressure measured by the maximum inspiratory pressure meter and marked on the training device. A single training session will consist of five sets, each containing five inspirations (total 25 breaths) with one minute of recovery between sets. The resistance will be adjusted every week to remain at 60% of the newly measured maximum inspiratory pressure; if the value remains unchanged, the patient will continue training at the previous week's level.
- Aerobic exercise (group A) Patients in group 1 will perform intradialytic aerobic exercise on a stationary bicycle ergometer. A 5-minute warm-up before exercise and a 5-minute cool-down after exercise at 30-40% of maximum heart rate will be carried out each session. The main aerobic training phase will consist of 20 minutes of cycling at moderate intensity (approximately 70-80% of maximum heart rate). Training will be performed in the first half of the dialysis session over a 3-month period, three sessions per week. Patients will use a stationary bicycle ergometer in the supine or semi-recumbent position for a minimum of 30 minutes per hemodialysis session, and speed, load and duration will be gradually increased according to patient performance and tolerance. Training loads will be adjusted based on clinical response and perceived exertion.
- Resistance exercise (group B) Patients in group 2 will perform dynamic closed-chain and open-chain resistance exercises targeting the quadriceps and hamstring muscles. Training will start at 50% of the initial 1RM with 5 repetitions for each exercise. It will then be progressed to three sets of 8 repetitions at 70% of 1RM, guided by the patient's Borg scale rating of exertion. Training loads will be increased when patients can comfortably complete three sets with good form. The training resistance will be adjusted according to newly measured 1RM values.
- Control group (group C) Patients in the control group will receive medical treatment and standard hemodialysis care only, with no structured intradialytic exercise program. They will undergo the same schedule of assessments as the intervention groups.
Purpose of the study
The purpose of this study is to evaluate the effect of:
Combined inspiratory muscle training with aerobic exercise (group 1), and
Combined inspiratory muscle training with resistance exercise (group 2),
compared with medical treatment alone (control group), in hemodialysis CKD patients with respect to the following outcomes:
Medical status of the patient (heart rate, blood pressure, oxygen saturation).
Laboratory analysis (GFR, serum creatinine, blood urea and BUN).
Inspiratory muscle pressure (MIP).
Dialysis period and duration.
Weight, height and BMI.
Quality of life (KDQOL questionnaire).
Modified Borg scale scores (dyspnea and fatigue).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise plus inspiratory muscle training (group A) | Active comparator | Device: aerobic exercise, Other: standard medical treatment, Device: inspiratory muscle trainingI)inspiratory muscle training: Inspiratory muscle training at 60% of maximal inspiratory pressure for 30 minutes/ session, 3 days a week, for 3 months Each patient breathes through a separate mouthpiece. The resistance is adjusted at 60% of maximum inspiratory pressure detected from maximum inspiratory pressure meter and is marked on the training device. A single training session consists of five sets, each contains five inspirations with total of twenty five breaths with one minute of recovery between each set. The resistance was adjusted every week to be 60% of the new maximum inspiratory pressure and if it remained the same, the subject continued to train at the level of the previous week Aerobic exercise: 5-minute warm-up before exercise and a 5-minute cool-down following exercise at intensity (40-65%HR reserve) were carried out each time. In addition, the exercise was performed in the first half of the dialysis session over a 3 months period for 3 sessions per week . |
| Resistance exercise plus inspiratory muscle training (group B) | Active comparator | Device: resistance exercise, Other: standard medical treatment, Device: inspiratory muscle trainingResistance exercise: Dynamic closed- and open-chain resistance exercises performed by the patients quadriceps and hamstrings muscles . Patients started at 50% of their initial one-repetition maximum (1-RM) with 5 repetitions for each exercise and later progressed to three sets of 8 repetitions at 70% of their 1-RM according to the patient Borg scale of exertion; training loads were increased when patients could comfortably complete three sets with good form. inspiratory muscle training: Inspiratory muscle training at 60% of maximal inspiratory pressure for 30 minutes/ session, 3 days a week, for 3 months Each patient breathes through a separate mouthpiece. The resistance is adjusted at 60% of maximum inspiratory pressure detected from maximum inspiratory pressure meter and is marked on the training device. A single training session consists of five sets, each contains five inspirations with total of twenty five breaths with one minute of recovery between each set. |
| group C (control group) | Active comparator | Other: standard medical treatmentin this group there is no exercise ,patients have assessment pre and post 3 months and follow up |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients from both gender
- With chronic kidney disease
- Unemployed living a sedentary lifestyle
- Receive regular hemodialysis sessions at 3months ago
- All of them have vascular access through arteriovenous fistula
Key exclusion criteria (12 listed)
- • Real difficulties with understanding and signing The written informed consent
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 exerciseAerobic exercise: by bicycle ergomete 5-minute warm-up before exercise and a 5-minute cool-down following exercise at intensity (40-65%HR max) were carried out each time. In addition, the exercise was performed in the first half of the dialysis session over a 3 months period for 3 sessions a week | Device | Aerobic exercise plus inspiratory muscle training (group A) |
| resistance exerciseDynamic closed- and open-chain resistance exercises performed by the patients' quadriceps and hamstring muscles. Patients started at 50% of their initial one-repetition maximum (1-RM) with 5 repetitions for each exercise and later progressed to three sets of 8 repetitions at 70% of their 1-RM according to the patient's Borg scale of exertion; training loads were increased when patients could comfortably complete three sets with good form. | Device | Resistance exercise plus inspiratory muscle training (group B) |
| standard medical treatmentstandard medical treatment | Other | Aerobic exercise plus inspiratory muscle training (group A), Resistance exercise plus inspiratory muscle training (group B), group C (control group) |
| inspiratory muscle trainingInspiratory muscle training at 60% of maximal inspiratory pressure for 30 minutes/session, 3 days a week, for 3 months Each patient breathes through a separate mouthpiece. The resistance is adjusted at 60% of the maximum inspiratory pressure detected from the maximum inspiratory pressure meter and is marked on the training device. A single training session consists of five sets, each containing five inspirations, with a total of twenty-five breaths with one minute of recovery between each set. The resistance was adjusted every week to be 60% of the new maximum inspiratory pressure and if it remained the same, the subject continued to train at the level of the previous week. | Device | Aerobic exercise plus inspiratory muscle training (group A), Resistance exercise plus inspiratory muscle training (group B) |
Primary outcome
6minute walk test
Time frame: Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)
-6 minute walk test : to detect functional capacity , carry out in a 30 meters line along the passage way , the tape is placed every 2 meter . patients are instructed to walk the longest possible distance in 6 minutes continuously and turning around at the final mark without stopping .they are instructed to walk as far as they can for 6 minutes without running or jogging .covered distance in meters is measured at the end of analysis.
Maximum inspiratory pressure
Time frame: Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)
-Maximum inspiratory pressure : to determine the inspiratory muscle strength before and after training. the patient will be instructed to insert the mouthpiece into the mouth, ensuring the flange is positioned over the gums and inside the lips, while the 'bite blocks' are between the teeth. The subject should then exhale to RV (Residual Volume), then perform a forced inhalation against the mouthpiece with as much effort as possible for as long as possible (minimum 2 seconds). while the participants were seated in a reclining chair (with knees and hips at 90) in a HD room at the beginning of the HD session .
6 secondary outcomes
Kidney Disease & Quality of Life (KDQOL-SF36)
Time frame: Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)
peak vo2
Time frame: Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)
modified Borg scale
Time frame: Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)
creatinine
Time frame: Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)
GFR
Time frame: Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)
KT/V
Time frame: Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)
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 10 Mar 2026.
- Results publicationRhee et al,2019
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherine H Mehani, professor principal investigator
Beni-Suef 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 aerobic exercise, resistance exercise and standard medical treatment in people with Hemodialysis, run by Beni-Suef 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 12 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 10 Mar 2026. 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?
6minute walk test (time frame: Outcome will be assessed at baseline (start of the study), at 3 months (immediately after completion of the intervention), and at 6 months (3-month follow-up after the intervention)). 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?
On the ClinicalTrials.gov record for NCT06838299, which also lists 1 linked publication.
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 10 Mar 2026.