Effect of Intradialytic Resistance Versus Aerobic Exercise on Cardiovascular System in Patients on Regular Hemodialysis

NCT ID: NCT07054827

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-05
• Study Completion Date: 2025-11-20

Brief Summary

The purpose of the study is to compare the effect of resistance exercise and aerobic exercise on intradialytic hypotension in patients undergoing hemodialysis.

Detailed Description

Chronic kidney disease (CKD) is one of the leading causes of global morbidity and mortality. In the 2019 Global Burden of Disease study, CKD was among the top ten risks associated with the highest number of deaths worldwide, with a death toll of 3.16 million deaths.

Patients undergoing dialysis in Egypt in 2020 are mostly men (59%), and half of them are aged ≥55 years. Hypertension is the most common cause of end-stage kidney disease at 41%, followed by diabetes at 14%, whereas glomerulonephritis is the primary diagnosis in 3% of patients undergoing dialysis.

Hemodialysis (HD), continuous ambulatory peritoneal dialysis, and kidney transplantation are the three main modalities of renal replacement therapy. Hypotension is the most reported complication of routine outpatient HD treatments.

Toxic substances, also called uremic toxins, in the blood result in malaise, paraesthesia, mental impairment, peripheral circulatory disturbance, and muscle dysfunction.

While patients exercise during dialysis, those toxins move through the dialyzer with a large flux from the tissue to the vascular compartment. It results in increased muscle blood flow and opened capillary surface area. Besides, the intradialytic exercise showed not only better adoption and adherence but also a lower drop-out and greater compliance.

So, this study will investigate the effect of resistance and aerobic exercises on intradialytic hypotension in patients undergoing hemodialysis. thus, may affect the quality of life in chronic kidney disease dialysis patients. The results of this study may shed light on which of the selected exercises can decrease the risk of Intradialytic hypotension to help dialysis patients. To our knowledge, there are no previous similar studies.

Conditions

Hemodialysis Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Medical therapy group

Patients with chronic kidney disease will receive hemodialysis only, for four hours, 3 times per week.

Group Type: ACTIVE_COMPARATOR

Hemodialysis

Intervention Type: OTHER

The participants receive hemodialysis for 4 hours, 3 times per week

intra-dialytic resistive exercise group

Patients with chronic kidney disease will receive an intra-dialytic resistance exercise for 12 weeks (3 sessions/week) in addition to hemodialysis.

Group Type: EXPERIMENTAL

Hemodialysis

Intervention Type: OTHER

The participants receive hemodialysis for 4 hours, 3 times per week

Intradialytic resistive exercise

Intervention Type: OTHER

The participants will receive intradialytic resistive exercise for 12 weeks (3 sessions/ week).

Duration: 30 minutes during the first 2 hours of each dialysis session in a recumbent position or seated position.

Time of session: The program starts with a warm-up phase which is 3:5 minutes in the form of light aerobic and stretching exercises for big muscles and ends with a cooling down phase which is 3:5 in the form of light aerobic exercise.

The resistance exercises include exercises for the big muscles of only the Lower Limbs (LL) muscles of single and multiple-joint which are:1- Knee extensors, 2- Knee flexors, 3- Hip flexors, 4- Hip abductors and adductors. using sandbags of different weights. Sandbag weights are placed on the distal third of the tibia for LL exercises.

Intensity: On the Borg's Scale of Perceived Exertion, which will be measured every 5 minutes during exercise.

intra-dialytic aerobic exercise group

Patients with chronic kidney disease will receive an intra-dialytic aerobic exercise (leg pedaling) for 12 weeks (3 sessions/week) in addition to hemodialysis.

Group Type: EXPERIMENTAL

Hemodialysis

Intervention Type: OTHER

The participants receive hemodialysis for 4 hours, 3 times per week

Intradialytic aerobic exercise

Intervention Type: OTHER

Patients with chronic kidney disease will receive an intradialytic aerobic exercise for 12 weeks (3 sessions/ week).

Duration: 30 minutes during the first 2 hours of each dialysis session using a stationary bicycle ergometer in a supine position or seated position.

Time of session: The warming up and the cooling down phase consists of 5:10 minutes of slow Pedaling. the main exercise phase consisted of 20 minutes of cycling.

Intensity: The use of the Borg's Scale of Perceived Exertion (RPE) scale enables the intensity of the exercise to be adapted According to the tolerance of each patient.

The use of the RPE scale enables the intensity of the exercise to be adapted According to the tolerance of each patient, the aim was to obtain between 11 light And 14 somewhat hard.

Interventions

Hemodialysis

The participants receive hemodialysis for 4 hours, 3 times per week

Intervention Type: OTHER

Intradialytic resistive exercise

The participants will receive intradialytic resistive exercise for 12 weeks (3 sessions/ week).

Duration: 30 minutes during the first 2 hours of each dialysis session in a recumbent position or seated position.

Time of session: The program starts with a warm-up phase which is 3:5 minutes in the form of light aerobic and stretching exercises for big muscles and ends with a cooling down phase which is 3:5 in the form of light aerobic exercise.

The resistance exercises include exercises for the big muscles of only the Lower Limbs (LL) muscles of single and multiple-joint which are:1- Knee extensors, 2- Knee flexors, 3- Hip flexors, 4- Hip abductors and adductors. using sandbags of different weights. Sandbag weights are placed on the distal third of the tibia for LL exercises.

Intensity: On the Borg's Scale of Perceived Exertion, which will be measured every 5 minutes during exercise.

Intervention Type: OTHER

Intradialytic aerobic exercise

Patients with chronic kidney disease will receive an intradialytic aerobic exercise for 12 weeks (3 sessions/ week).

Duration: 30 minutes during the first 2 hours of each dialysis session using a stationary bicycle ergometer in a supine position or seated position.

Time of session: The warming up and the cooling down phase consists of 5:10 minutes of slow Pedaling. the main exercise phase consisted of 20 minutes of cycling.

Intensity: The use of the Borg's Scale of Perceived Exertion (RPE) scale enables the intensity of the exercise to be adapted According to the tolerance of each patient.

The use of the RPE scale enables the intensity of the exercise to be adapted According to the tolerance of each patient, the aim was to obtain between 11 light And 14 somewhat hard.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• End-stage renal disease (ESRD) or stage 5 chronic kidney disease (CKD) in which on maintenance regular HD (three sessions/week (on alternate days), for four hours/session for more than a year to five years when starting the study.
• Both gender male and female aged from 45 to 60 years old.
• Patients with intradialytic hypotension sudden drops of systolic pressure of more than 20 mm Hg or diastolic pressure of more than 10 mmHg.
• Receiving hemodialysis (HD) through uncomplicated arm arteriovenous (A-V) fistula.
• Patients with Body Mass Index (BMI): 18,5 < 30kg/m2.
• In a stable medical, clinical, and hemodynamic condition
• Untrained at baseline and did not participate in any regular physical activity before.

Exclusion Criteria

• Severe Chest diseases (either obstructive or restrictive).
• Clinical signs of a severe cardiac event. (eg, severe atherosclerosis, congestive heart failure),
• Severe psychiatric or cognitive impairment, who unable to follow comment.
• Neurological disorders affecting respiratory muscles or any muscular dystrophies (cervical disc or bulge).
• Patients with severe self-limiting illness (e.g., cancer).
• Patients with Body Mass Index (BMI) > 30kg/m2.
• Previous renal transplantation patients.
• Pregnant females or became pregnant during the study.
• Patients started HD in less than a year or more than 5 years.
• Hospitalized during the prior month.
• Patients who were irregular in HD or not adherent to the exercise program.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Yasmin Mohamed Mahmoud Gouda

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sahier El-Khashab, Professor

Role: STUDY_DIRECTOR

Cairo University

Nagwa Badr, Professor

Role: STUDY_CHAIR

Cairo University

Locations

Yasmin Mohamed Mahmoud Gouda

Cairo, , Egypt

Countries

Egypt

Central Contacts

Yasmin Gouda, Master

Role: CONTACT

yasmina200068guoda@gmail.com

20 10 08444667

Hend Abd El-Monaem, PHD

Role: CONTACT

Drhendpt@cu.edu.eg

+20 11 15507195

Other Identifiers

P.T.REC/012/005770

Identifier Type: -

Identifier Source: org_study_id