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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorCairo University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hemodialysis

    Other intervention

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

  • Intradialytic resistive exercise

    Other intervention

    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.

  • Intradialytic aerobic exercise

    Other intervention

    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.

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Medical therapy groupActive comparator 1 intervention
Group B: intra-dialytic resistive exercise groupExperimental treatment 2 interventions
Group C: intra-dialytic aerobic exercise groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks
2

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.

Time frame
12 weeks
3

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.

Time frame
12 weeks
4

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%.

Time frame
12 weeks

Secondary outcomes

1

Six minutes walking Test (6 MWT)

A 6-minute walk test (6MWT) is a major physical test in the dialysis population. Its value lies in the fact that it is a self-paced test of walking capacity and functional ability of daily physical activities which are mostly performed at submaximal level of exertion. 6MWT is a major physical tests in dialysis population. Its value lies in the fact that it is a self-paced test of walking capacity and reflects the functional ability at daily physical activities which are mostly performed at submaximal level of exertion. It is carried out in a 30 m long corridor. Subjects will be instructed to walk from end to end of the corridor and to cover the greatest distance possible in six minutes. Patients who need rest due to dyspnea will be instructed to continue walking as soon as they feel able, but the timer doesn't stop.

Time frame
12 weeks
2

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

is a self-reported measure of health that particularly concerns individuals with chronic kidney disease (CKD). The KDQOL-36 is a short version of KDQOL-SF that includes only 36 questions. The survey can be administered in 3-5 min, which saves both time and resources. Each subscale score ranges between 0 and 100, with increasing values equating to better health.

Time frame
12 weeks

Other outcomes

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