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

Overview

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.

Interventions

• Other Hemodialysis
  The participants receive hemodialysis for 4 hours, 3 times per week
• 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
• 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) sc

Primary outcome measures

• Systolic blood pressure measurement [Time frame: 12 weeks]
• Diastolic blood pressure measurement [Time frame: 12 weeks]
• Ankle-Brachial Index (ABI) [Time frame: 12 weeks]
• Peripheral oxygen saturation [Time frame: 12 weeks]
• Creatinine level [Time frame: 12 weeks]
• blood urea level [Time frame: 12 weeks]
• blood urea nitrogen test [Time frame: 12 weeks]
• serum albumin [Time frame: 12 weeks]

Secondary outcome measures (2)

• Six minutes walking Test (6 MWT) [Time frame: 12 weeks]
• The Kidney Disease Quality of Life Short Form (KDQOL-SF) [Time frame: 12 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Yasmin Mohamed Mahmoud Gouda — Cairo

Identifiers

NCT: NCT07054827 · P.T.REC/012/005770

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗