NCT06838299

Two Different Renal Rehabilitation Protocols in Hemodialysis Patients

Comparative Study Between Two Different Renal Rehabilitation Protocols on Respiratory and Peripheral Muscles Strength in Hemodialysis Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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) 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. 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. 1. 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. 2. 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. 3. 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. 4. 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

Interventions

Type	Name	Description
DEVICE	aerobic exercise	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
DEVICE	resistance exercise	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.
OTHER	standard medical treatment	standard medical treatment
DEVICE	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 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.

Timeline

• Start date: 2025-02-28
• Primary completion: 2025-05-28
• Completion: 2025-08-28
• First posted: 2025-02-20
• Last updated: 2026-03-10

Locations

1 site across 1 country: Egypt