HemodialysisNCT05889130
Optimal Timing for Resistance Exercise in Hemodialysis
A study testing Resistant Exercise in people with Hemodialysis, run by Muş Alparslan University at 2 sites in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Resistant Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 13 May 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have been on HD treatment for at least 6 months
- To be receiving HD treatment for 4 hours 3 days a week
- 18 to 90 years old
Who cannot join
- Having angina pectoris or uncontrolled arrhythmia and uncontrolled hypertension
- Having communication or cognitive problems at a level that cannot fulfill the requirements of the tests
- Having an orthopedic problem that cannot do the exercise
- Have upcoming travel or kidney transplant plans
- Having an intradialytic hypotensive attack in 3 consecutive sessions
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Marmara University
Istanbul
Mus Alparslan University
Muş, Güzeltepe District, 49100
About this study
Official title: What Is the Optimal Timing for Intradialytic Resistance Exercise? A Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Hemodialysis
- Being tested
- Resistant Exercise
- Keywords
- Hemodialysis, Resistant exercise, Blood Presure, Physical Performance, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant ExerciseOther
The exercises were planned to be performed in 3 sets, 10 repetitions in each set, with 3 minutes rest between sets. Before starting the main exercises, it was planned to do 1 set of the same exercises without weight as a warm-up and cool-down exercise.
Exercises were planned as lower extremity hip abduction, adduction, flexion and extension, straight leg raise, terminal knee extension, ankle flexion and bridge exercises. During the exercises, it was planned to be combined with breathing, paying attention to respiratory control.
| Study group | Role | What they receive |
|---|---|---|
| first two hours of exercise group | Active comparator | This is the group that will do resistance exercise in the first two hours of the hemodialysis session. Receives: Other: Resistant Exercise |
| last two hours of exercise group | Active comparator | This is the group that will do resistance exercise in the last two hours of the hemodialysis session. Receives: Other: Resistant Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic and diastolic blood pressure will be measured
Measured: Change from baseline and 8 weeks systolic and diastolic blood pressure
Secondary outcomes (2)
The Short Physical Performance Battery Scale
The Short Physical Performance Battery (SPPB) is widely used to reduce the body and functional performance of the elderly living in the community. SPPB consists of 3 objective tests evaluating lower body structures. These; It is a 4 meter walking, standing up and standing balance test. A summary score of 5 levels (0-4) was assigned for each test. A score of zero indicates "Failure to fulfill". Participants included in the category of "not able to perform": 1- Those who tried to do the activity but could not do the activity, 2- The interviewer or the subject felt insecure, 3- Those who could not do the activity due to other health reasons (eg, too ill, too much follow-up monitoring). Scores of 1-4 obtained by the subjects show the progressive performance required to fulfill the test according to the times. The durations of the functions performed by the patients are recorded using a stopwatch.
Measured: baseline and 8 weeks
Kidney Disease Quality of Life-36
Quality of Life
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start13 May 2023
- Primary completion7 Oct 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Bingölbali, Muş Alparslan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889130
- Sponsor's protocol ID
- 2023-86766
- Other IDs
- 2023
- Status last verified
- Sep 2025
- First submitted
- 16 May 2023
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Is the Optimal Timing for Intradialytic Resistance Exercise? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05889130
- Acronym / sponsor ID
- 2023-86766
- Conditions
- Hemodialysis
- Keywords
- Hemodialysis, Resistant exercise, Blood Presure, Physical Performance, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 13 May 2023 (actual)
- Primary completion
- 7 Oct 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first two hours of exercise group | Active comparator | Other: Resistant ExerciseThis is the group that will do resistance exercise in the first two hours of the hemodialysis session. |
| last two hours of exercise group | Active comparator | Other: Resistant ExerciseThis is the group that will do resistance exercise in the last two hours of the hemodialysis session. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have been on HD treatment for at least 6 months
- To be receiving HD treatment for 4 hours 3 days a week
- 18 to 90 years old
Key exclusion criteria (5 listed)
- Having angina pectoris or uncontrolled arrhythmia and uncontrolled hypertension
- Having communication or cognitive problems at a level that cannot fulfill the requirements of the tests
- Having an orthopedic problem that cannot do the exercise
- Have upcoming travel or kidney transplant plans
- Having an intradialytic hypotensive attack in 3 consecutive sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistant ExerciseThe exercises were planned to be performed in 3 sets, 10 repetitions in each set, with 3 minutes rest between sets. Before starting the main exercises, it was planned to do 1 set of the same exercises without weight as a warm-up and cool-down exercise. Exercises were planned as lower extremity hip abduction, adduction, flexion and extension, straight leg raise, terminal knee extension, ankle flexion and bridge exercises. During the exercises, it was planned to be combined with breathing, paying attention to respiratory control. | Other | first two hours of exercise group, last two hours of exercise group |
Primary outcome
systolic and diastolic blood pressure will be measured
Time frame: Change from baseline and 8 weeks systolic and diastolic blood pressure
2 secondary outcomes
The Short Physical Performance Battery Scale
Time frame: baseline and 8 weeks
Kidney Disease Quality of Life-36
Time frame: baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistant Exercise in people with Hemodialysis, run by Muş Alparslan University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
systolic and diastolic blood pressure will be measured (time frame: Change from baseline and 8 weeks systolic and diastolic blood pressure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025; AzTrials last refreshed its copy on 31 Oct 2026.