HemolysisNCT04098848
Intradialytic Exercise on the Fatigue, Sleep Disorder, Arterial Stiffness and Endothelial Function in Uremic Patients
A study testing Cycling exercise in people with Hemolysis and Exercise, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
To determine the effect of intradialytic cycling exercise on fatigability, sleep disorders, arterial stiffness and endothelial function in dialysis patients Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hemolysis, Exercise, Sleep Disorder
- What is being tested?
- Cycling exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2018to 31 Dec 2021
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Regular hemodialysis more than 3 months with 4 hours a time, thrice a week
- Eligible to sign permit
Who cannot join
- Could not sign permit or do not want to join the trial
- Infection
- Amputation of any one of the lower limb
- Hemodynamic unstable
- Acute myocardial infarction (AMI) in recent 6 months
- Unstable heart condition, such as unstable angina, arrythmia
Show all 9Show fewer
- Deep vein thrombosis (DVT)
- History of kidney transplantation
- Vascular access over lower limb
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intradialytic Exercise on the Fatigue, Sleep Disorder, Arterial Stiffness and Endothelial Function in Uremic Patients
To determine the effect of intradialytic cycling exercise on fatigability, sleep disorders, arterial stiffness and endothelial function in dialysis patients
Read the detailed description
The endothelium is a key regulator of vascular homeostasis and chronic exposure to vascular risk factors alters the regulatory properties of the endothelium, which progresses toward a pro-inflammatory pattern, senescence, and apoptosis. Endothelial cell integrity and function are critical to the prevention of atherosclerosis, and therefore endothelial cell injury and dysfunction are major steps in the development and progression of cardiovascular disease. Endothelial dysfunction may be the landmark of active disease process through the course of atherosclerotic cardiovascular disease, and a significant risk factor for future cardiovascular events.
Several studies had reported that not only medical treatment but also exercise could improve physical and vascular functions, dialytic efficiency, quality of sleep, fatigue and depression et al. Exercise could be classified to aerobic, Anaerobic exercise and resistance et. Several studies have shown that regular cycling exercise in hemodialysis patients could improve physical activity, sleep quality, and reduce fatigability. Therefore, exercise plays an important role in hemodialysis patients. According to these benefits, the investigator's study was designed to explore the effects of intradialytic cycling exercise on sleep quality and fatigability, adipokines and myokinins levels in hemodialysis patients.
- Conditions
- Hemolysis, Exercise, Sleep Disorder, Fatigue, Adipocytes
- Being tested
- Cycling exercise
- Medical subject headings
- Hemolysis, Motor Activity, Sleep Wake Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycling exerciseOther
Intradialytic cycling exercise for 30 minutes a time
| Study group | Role | What they receive |
|---|---|---|
| Intradialytic exercise | Experimental | Cycling exercise 30 minutes a time, three times a week during hemodialysis Receives: Other: Cycling exercise |
| Control group | No intervention | not participate in cycling exercise during hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-F) score for 2 years
Compare the FACIT-F score before, during and after intradialytic cycling exercise FACIT-F score is from 0-52 points; higher score represents less fatigue.
Measured: pre-test and then every 3 months for 2 years
Change of the Pittsburgh Sleep Quality Index (PSQI) score for 2 years
Compare the PSQI score before, during and after intradialytic cycling exercise PSQI score is from 0-21 points; score>=5 means poor sleeping quality.
Measured: pre-test and then every 3 months for 2 years
Change of the carotid-femoral pulse wave velocity (cfPWV) for 2 years
Compare the cfPWV before, during and after intradialytic cycling exercise
cfPWV measurement: a measure of aortic wall stiffness, increases markedly with age. Each set of pulse wave and ECG data to calculate the mean time difference between R-wave and pulse wave on a beat-to-beat basis, with an average of 10 consecutive cardiac cycles. The cfPWV will be calculated using the distance and mean time difference between the two recorded points.
Patients with cfPWV values of > 10 m/s were classified in the high arterial stiffness group, whereas those with cfPWV values of ≤10 m/s were assigned to the low arterial stiffness group.
Measured: pre-test and then every 3 months for 2 years
Change of the cardio-ankle vascular index (CAVI) for 2 years
Compare the CAVI before, during and after intradialytic cycling exercise
CAVI is a novel and accurate method, independent of the effect of blood pressure, and is used as a predictor of arterial stiffness (AS) AS was defined as a CAVI ≥ 9
Measured: pre-test and then every 3 months for 2 years
Change of the brachial-ankle pulse wave velocity (baPWV) for 2 years
Compare the baPWV before, during and after intradialytic cycling exercise
baPWV is one measure arterial stiffness using brachial to ankle arterial wave analyses and has been used to assess peripheral arterial stiffness (PAS)
baPWV value >14.0 m/s on either side was considered high PAS.
Measured: pre-test and then every 3 months for 2 years
Change of the aortic augmentation index(AI) measurements for 2 years
Compare the AI before, during and after intradialytic cycling exercise
AI of central blood pressure have been widely used as clinical indices of arterial stiffness AI is an indirect measure of central arterial stiffness, but mainly a direct measure of central wave reflection
Measured: pre-test and then every 3 months for 2 years
Change of the brachial flow-mediated vasodilatation (bFMD) for 2 years
Compare the bFMD before, during and after intradialytic cycling exercise
Endothelial function is often quantified by FMD, which represents the endothelium-dependent relaxation of a conduit artery-typically the brachial artery - due to an increased blood flow.
Measured: pre-test and then every 3 months for 2 years
Change of the digital thermal monitoring (DTM) for 2 years
Compare the DTM before, during and after intradialytic cycling exercise
DTM is a simple noninvasive method to measure endothelial function and vascular reactivity that is correlated with atherosclerosis risk factors and coronary artery disease
Vascular reactivity index (VRI) < 1.0: the poor vascular reactivity, 1.0 ≤ VRI < 2.0: the intermediate vascular reactivity, and VRI ≥ 2.0: the good vascular reactivity.
Measured: pre-test and then every 3 months for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start1 Jan 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemolysisStudies 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
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Hsien Lai, Principal investigator, Attending physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098848
- Sponsor's protocol ID
- IRB106-139-A
- Status last verified
- Mar 2022
- First submitted
- 15 Sep 2019
- Last updated
- 2 Mar 2022
- 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 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intradialytic Exercise on the Fatigue, Sleep Disorder, Arterial Stiffness and Endothelial Function in Uremic Patients
- ClinicalTrials.gov ID
- NCT04098848
- Acronym / sponsor ID
- IRB106-139-A
- Conditions
- Hemolysis, Exercise, Sleep Disorder, Fatigue, Adipocytes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 Sep 2019 (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.
To determine the effect of intradialytic cycling exercise on fatigability, sleep disorders, arterial stiffness and endothelial function in dialysis patients
Detailed description
The endothelium is a key regulator of vascular homeostasis and chronic exposure to vascular risk factors alters the regulatory properties of the endothelium, which progresses toward a pro-inflammatory pattern, senescence, and apoptosis. Endothelial cell integrity and function are critical to the prevention of atherosclerosis, and therefore endothelial cell injury and dysfunction are major steps in the development and progression of cardiovascular disease. Endothelial dysfunction may be the landmark of active disease process through the course of atherosclerotic cardiovascular disease, and a significant risk factor for future cardiovascular events.
Several studies had reported that not only medical treatment but also exercise could improve physical and vascular functions, dialytic efficiency, quality of sleep, fatigue and depression et al. Exercise could be classified to aerobic, Anaerobic exercise and resistance et. Several studies have shown that regular cycling exercise in hemodialysis patients could improve physical activity, sleep quality, and reduce fatigability. Therefore, exercise plays an important role in hemodialysis patients. According to these benefits, the investigator's study was designed to explore the effects of intradialytic cycling exercise on sleep quality and fatigability, adipokines and myokinins levels in hemodialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intradialytic exercise | Experimental | Other: Cycling exerciseCycling exercise 30 minutes a time, three times a week during hemodialysis |
| Control group | No intervention | –not participate in cycling exercise during hemodialysis |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Regular hemodialysis more than 3 months with 4 hours a time, thrice a week
- Eligible to sign permit
Key exclusion criteria (9 listed)
- Could not sign permit or do not want to join the trial
- Infection
- Amputation of any one of the lower limb
- Hemodynamic unstable
- Acute myocardial infarction (AMI) in recent 6 months
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 |
|---|---|---|
| Cycling exerciseIntradialytic cycling exercise for 30 minutes a time | Other | Intradialytic exercise |
Primary outcome
Change of the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-F) score for 2 years
Time frame: pre-test and then every 3 months for 2 years
Compare the FACIT-F score before, during and after intradialytic cycling exercise FACIT-F score is from 0-52 points; higher score represents less fatigue.
Change of the Pittsburgh Sleep Quality Index (PSQI) score for 2 years
Time frame: pre-test and then every 3 months for 2 years
Compare the PSQI score before, during and after intradialytic cycling exercise PSQI score is from 0-21 points; score>=5 means poor sleeping quality.
Change of the carotid-femoral pulse wave velocity (cfPWV) for 2 years
Time frame: pre-test and then every 3 months for 2 years
Compare the cfPWV before, during and after intradialytic cycling exercise cfPWV measurement: a measure of aortic wall stiffness, increases markedly with age. Each set of pulse wave and ECG data to calculate the mean time difference between R-wave and pulse wave on a beat-to-beat basis, with an average of 10 consecutive cardiac cycles. The cfPWV will be calculated using the distance and mean time difference between the two recorded points. Patients with cfPWV values of > 10 m/s were classified in the high arterial stiffness group, whereas those with cfPWV values of ≤10 m/s were assigned to the low arterial stiffness group.
Change of the cardio-ankle vascular index (CAVI) for 2 years
Time frame: pre-test and then every 3 months for 2 years
Compare the CAVI before, during and after intradialytic cycling exercise CAVI is a novel and accurate method, independent of the effect of blood pressure, and is used as a predictor of arterial stiffness (AS) AS was defined as a CAVI ≥ 9
Change of the brachial-ankle pulse wave velocity (baPWV) for 2 years
Time frame: pre-test and then every 3 months for 2 years
Compare the baPWV before, during and after intradialytic cycling exercise baPWV is one measure arterial stiffness using brachial to ankle arterial wave analyses and has been used to assess peripheral arterial stiffness (PAS) baPWV value >14.0 m/s on either side was considered high PAS.
Change of the aortic augmentation index(AI) measurements for 2 years
Time frame: pre-test and then every 3 months for 2 years
Compare the AI before, during and after intradialytic cycling exercise AI of central blood pressure have been widely used as clinical indices of arterial stiffness AI is an indirect measure of central arterial stiffness, but mainly a direct measure of central wave reflection
Change of the brachial flow-mediated vasodilatation (bFMD) for 2 years
Time frame: pre-test and then every 3 months for 2 years
Compare the bFMD before, during and after intradialytic cycling exercise Endothelial function is often quantified by FMD, which represents the endothelium-dependent relaxation of a conduit artery-typically the brachial artery - due to an increased blood flow.
Change of the digital thermal monitoring (DTM) for 2 years
Time frame: pre-test and then every 3 months for 2 years
Compare the DTM before, during and after intradialytic cycling exercise DTM is a simple noninvasive method to measure endothelial function and vascular reactivity that is correlated with atherosclerosis risk factors and coronary artery disease Vascular reactivity index (VRI) < 1.0: the poor vascular reactivity, 1.0 ≤ VRI < 2.0: the intermediate vascular reactivity, and VRI ≥ 2.0: the good vascular reactivity.
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 2 Mar 2022.
- 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.
Yu-Hsien Lai principal investigator
Attending physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycling exercise in people with Hemolysis and Exercise, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
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 2 inclusion and 9 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 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Change of the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-F) score for 2 years (time frame: pre-test and then every 3 months for 2 years). The study lists 8 primary outcomes in all. 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 2 Mar 2022.