An interventional study of aerobic exercise and resistance exercise in Hemodialysis, sponsored by Beni-Suef University. Completed at 1 site in Egypt. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment
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.
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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.
A) 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).
B) 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.
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).
Beni-Suef University is the lead sponsor of 333 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Real difficulties with understanding and signing The written informed consent
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 .
Device: aerobic exercise · Other: standard medical treatment · Device: inspiratory muscle training
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.
Device: resistance exercise · Other: standard medical treatment · Device: inspiratory muscle training
in this group there is no exercise ,patients have assessment pre and post 3 months and follow up
Other: standard medical treatment
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
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 treatment
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.
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.
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
-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 .
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)
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
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
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
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
It assess The sensation of dyspnea, fatigue of lower limbs during walk
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
ab analysis for kidney function
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
lab analysis for kidney function
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
lab analysis for kidney function
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)
Plan to share: No
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Beni-Suef University