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

NCT07054827 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005770
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Complication

Outcome Measures

Primary Outcomes (8)

• Systolic blood pressure measurement

  Blood pressure (BP) will be measured on the non-access arm using automatic BP cuffs attached to the patient's hemodialysis machine which is used routinely at each respective hemodialysis clinic. As well as for ankle brachial pressure index. Systolic blood pressure measurements will be taken pre-hemodialysis, at hemodialysis start (baseline), post-hemodialysis, and every 15 minutes during each dialysis session. BP measurements will be taken before selected exercise and after exercise.

  12 weeks

• Diastolic blood pressure measurement

  Blood pressure (BP) will be measured on the non-access arm using automatic BP cuffs attached to the patient's hemodialysis machine which is used routinely at each respective hemodialysis clinic. As well as for ankle brachial pressure index. diastolic blood pressure measurements will be taken pre-hemodialysis, at hemodialysis start (baseline), post-hemodialysis, and every 15 minutes during each dialysis session. BP measurements will be taken before selected exercise and after exercise.

  12 weeks

• Ankle-Brachial Index (ABI)

  This non-invasive test compares blood pressure in the ankles to blood pressure in the arms. An ABI below 0.9 usually suggests peripheral artery disease (PAD), a common cause of circulatory issues.

  12 weeks

• Peripheral oxygen saturation

  Pulse oximetry is a non-invasive method used to measure the oxygen saturation level (SpO2) in the blood, providing an estimate of how much oxygen the hemoglobin in red blood cells is carrying. It provides data on oxygen delivery to extremities, which may be impaired in circulation issues. Normally, its value is 95-99%.

  12 weeks

• Creatinine level

  Blood analysis will be used to measure creatinine level for all patients before and after intervention. Its values vary by sex; 0.6-1.2 mg/dl for men and 0.5-1.1 mg/dl for women.

  12 weeks

• blood urea level

  Blood analysis will be used to measure blood urea for all patients before and after intervention. its normal value ranges from 17-43 mg/dl.

  12 weeks

• blood urea nitrogen test

  Blood analysis will be used to measure blood urea nitrogen for all patients before and after intervention. its normal value ranges from 7-20 mg/dl.

  12 weeks

• serum albumin

  Blood analysis will be used to measure serum albumin for all patients before and after intervention. its normal value in adults is typically 3.5-5.0 g/L.

  12 weeks

Secondary Outcomes (2)

• Six minutes walking Test (6 MWT)

  12 weeks

• The Kidney Disease Quality of Life Short Form (KDQOL-SF)

  12 weeks

Study Arms (3)

Medical therapy group

ACTIVE COMPARATOR

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

Other: Hemodialysis

intra-dialytic resistive exercise group

EXPERIMENTAL

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

Other: Hemodialysis; Other: Intradialytic resistive exercise

intra-dialytic aerobic exercise group

EXPERIMENTAL

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

Other: Hemodialysis; Other: Intradialytic aerobic exercise

Interventions

Hemodialysis OTHER

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

Medical therapy group; intra-dialytic aerobic exercise group; intra-dialytic resistive exercise group

Intradialytic resistive exercise 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 resistive exercise group

Intradialytic aerobic exercise 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.

intra-dialytic aerobic exercise group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Yasmin Mohamed Mahmoud Gouda

Cairo, Egypt

Location

MeSH Terms

Interventions

Renal Dialysis

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Study Officials

• Sahier El-Khashab, Professor

  Cairo University

  STUDY DIRECTOR

• Nagwa Badr, Professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Yasmin Gouda, Master

CONTACT

20 10 08444667; yasmina200068guoda@gmail.com

Hend Abd El-Monaem, PHD

CONTACT

+20 11 15507195; Drhendpt@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 28, 2025
• First Posted: July 8, 2025
• Study Start: July 5, 2025
• Primary Completion: November 5, 2025
• Study Completion: November 20, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-06

Locations

EG (1)