Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05889130 |
Other study ID # |
2023-86766 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 1, 2023 |
Est. completion date |
June 30, 2023 |
Study information
Verified date |
May 2023 |
Source |
Mus Alparlan University |
Contact |
Ömer BINGÖLBALI |
Phone |
+905349240188 |
Email |
o.merbingolbali[@]alparslan.edu.tr |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The study consists of two groups doing resistance exercise for the first and last two hours
of the HD session. The investigators are planning to form the sample size of exercise
training from 40 participants, which the investigators determined according to the power
analysis the investigators have done based on the blood pressure outcome criterion.
Participants who meet the inclusion criteria the investigators have set will be divided into
two groups. A resistance exercise training will be given three days a week for eight weeks,
with a total of 24 sessions. The number of IRCAs occurring in both groups and blood pressure
values to be measured at the beginning and end of the HD session will be checked, and both
parameters will be compared between the groups before and after the treatment after 8 weeks
of training. Thus, the investigators aim to show how the time factor has an effect on blood
pressure. In addition, muscle strength, physical performance and quality of life of
participants before and after resistance exercise will be evaluated and compared between
groups. The participants' blood pressure will be evaluated with a conventional cuffed
sphygmomanometer, muscle strength, digital hand dynamometer, physical performance, Short
Physical Performance Battery and Timed Up and Go Test, and their quality of life will be
evaluated with the Kidney Disease Quality of Life-36 (KDQOL-36) quality of life
questionnaire. In exercise training, sandbags will be used as resistance. In our study, which
the investigators planned as a randomized controlled trial, stratified randomization method
will be used to distribute the gender factor homogeneously in both groups.
Description:
Purpose and Objective: The aim of our study is to examine the effect of intradialytic (IR)
resistance exercise time on blood pressure, physical performance and quality of life in
hemodialysis (HD) patients. With this study we are planning to do, we aim to help HD patients
regulate their blood pressure values and increase their muscle strength so that they can be
more independent in their daily living activities and thus improve their quality of life.
Original Value: HD is the reorganization of the fluid and solute content of the blood taken
from the patient by means of a membrane and with the help of a machine. The treatment
requirements of HD patients (the HD session is usually applied two or three days a week and
each application takes about 4 hours, as well as the plasma withdrawal from the body during
HD) and long-term immobilization usually cause low blood pressure. This may cause some
patients to have an intradialytic hypotensive attack (IDHA) due to the excessive decrease in
blood pressure during HD. IDHA, on the other hand, is associated with severe abdominal pain,
nausea, vomiting, dizziness, blackout, muscle cramps, with a decrease in systolic blood
pressure of more than 20 mmHg compared to the predialysis (pre-dialysis) value or a decrease
in mean systolic pressure of more than 10 mmHg from the predialysis value. It is defined as
the coexistence of symptoms such as cramps and severe anxiety.
It is a known fact that regular exercises have a blood pressure lowering effect in the
chronic period, and it is observed that exercises performed regardless of type (aerobic,
resistant or combined) increase blood pressure in the acute period. Because blood flow is
restricted due to the increase in pressure in the muscle during exercise, metabaroreceptors
and mechanoreceptors in the active muscle stimulate the cardiovascular center in the medulla,
and both systolic and diastolic pressure increase in order to exclude intramuscular pressure
and provide perfusion. This is a response of the body to exercise and occurs as a result of
normal physiological mechanisms.
Due to theoretical concerns that the exercise applied in the last two hours of the HD session
may exacerbate hemodynamic instability, it is generally recommended to exercise in the first
two hours of HD. However, there is also evidence showing that exercise can be done in the
last two hours of the HD session. The increase in these evidences, especially in recent
years, reveals that there is a need for studies on the effectiveness and reliability of IR
exercise application time. The tendency of the blood pressure to drop more in the last half
of the HD session (due to the increase in the amount of plasma withdrawn from the patients as
time progresses) suggests that an exercise program that can be given in these minutes may
provide a significant benefit to the patients, considering the acute blood pressure-raising
effect.
From another point of view, studies show that resistance exercises (because it increases
intramuscular pressure more) increase blood pressure more in the acute period than aerobic
exercises. There are limited studies comparing the effects of aerobic and resistance
exercises on blood pressure in HD patients. Limited existing studies have also revealed that
resistance exercise raises blood pressure more than aerobic exercise in the acute period in
HD patients. Therefore, it is thought that it would be more beneficial to include resistant
exercises in the exercise program to be given to the patients in the last two hours.
However, many studies have proven that resistance exercises have a greater muscle
strengthening effect when compared to aerobic exercises. It is known that the immobilization
that HD patients are exposed to due to the long frequency and duration of dialysis sessions
causes significant decreases in muscle strength. Therefore, it is expected that one of the
main problems HD patients suffer from is falling, and there are studies supporting this
situation. When all these points are evaluated, it is seen that resistance exercises are in a
strategic position in HD patients. Therefore, considering the curative effect of muscle
strengthening on physical performance parameters, it becomes important again that resistant
exercises should be applied in HD patients. In addition, despite the limited range of motion
of patients during HD, exercise therapy is not effective. It is extremely important that lay
is a feasible treatment. However, since exercise therapy is relatively simple, easily
applicable, non-invasive, and low-cost compared to other treatments, and also allows the
patient to actively participate in his own treatment, it can also provide a useful
self-management understanding in this sense by creating the perception that the patient is
responsible for his own health. In addition, we think that the application of exercise
therapy in HD units in our country will also support its spread, thanks to the effects we
have mentioned above.
Method: Our study consists of two groups doing resistance exercise for the first and last two
hours of the HD session. We are planning to form the sample size of exercise training from 40
patients, which we determined according to the power analysis we have done based on the blood
pressure outcome criterion. Patients who meet the inclusion criteria we have set will be
divided into two groups. A resistance exercise training will be given three days a week for
eight weeks, with a total of 24 sessions. The number of IRCAs occurring in both groups and
blood pressure values to be measured at the beginning and end of the HD session will be
checked, and both parameters will be compared between the groups before and after the
treatment after 8 weeks of training. Thus, we aim to show how the time factor has an effect
on blood pressure. In addition, muscle strength, physical performance and quality of life of
patients before and after resistance exercise will be evaluated and compared between groups.
The patients' blood pressure will be evaluated with a conventional cuffed sphygmomanometer,
muscle strength, digital hand dynamometer, physical performance, Short Physical Performance
Battery and Timed Up and Go Test, and their quality of life will be evaluated with the Kidney
Disease Quality of Life-36 (KDQOL-36) quality of life questionnaire. In exercise training,
sandbags will be used as resistance. In our study, which we planned as a randomized
controlled trial, stratified randomization method will be used to distribute the gender
factor homogeneously in both groups.