Hemodialysis ComplicationNCT06575634
Exercise Therapy on Rheological Functions of Erythrocyte in Hemodialysis
A study testing Supervised exercise training in people with Hemodialysis Complication, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
To improve aerobic capacity, muscular function, and health-related quality of life in patients with end-stage renal disease (ESRD), regular exercise is recommended. Supervised intradialytic exercise at moderate intensity is a viable approach to ensure patient safety, maintain compliance, and effectively enhance… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- Supervised exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2022to 31 Jul 2025
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Receiving hemodialysis and medication at least for 6 weeks
- Kt/V score > 1.2
Who cannot join
- Under 20 years-old
- Hyperkalemia occurs within 3 month
- Having orthopedic or muscular diseases
- Other concerned medical, psychological or physiological diseases
- Pregnancy
- Other exercise contraindications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Supervised Exercise on Rheological Functions of Erythrocyte in Patients With End-Stage Renal Disease on Hemodialysis
To improve aerobic capacity, muscular function, and health-related quality of life in patients with end-stage renal disease (ESRD), regular exercise is recommended. Supervised intradialytic exercise at moderate intensity is a viable approach to ensure patient safety, maintain compliance, and effectively enhance physiological adaptations. However, the impact of exercise training on erythrocyte rheological properties in ESRD patients, such as red blood cell deformability, aggregation, and oxygen transport capacity, remains unclear.
Method: ESRD patients (anticipated n=180) will undergo supervised exercise training therapy three times per week for six months in the hospital, followed by three months at home. Cardiopulmonary exercise tests will be conducted before and after the intervention. Erythrocyte deformability and aggregation will be assessed using a laser-assisted optical rotational cell analyzer (LORCA), while additional protein levels and reactive oxygen species (ROS) status will be measured using a flow cytometer. This will help determine how exercise affects the rheological properties of red blood cells in this population.
Read the detailed description
Renal dysfunction often stems from cardiovascular-related comorbidities or metabolic disorders, leading to the accumulation of excessive inflammatory products or damaging the bioenergetic health of red blood cells. This eventually contributes to the development of chronic kidney disease (CKD). At the most advanced stage, known as end-stage renal disease (ESRD), patients suffer from severe uremia and renal failure, necessitating renal replacement therapy, typically in the form of dialysis.
Hemodialysis (HD) is the most common treatment for ESRD patients, especially in Taiwan, which has the highest global prevalence of HD due to related chronic diseases and a comprehensive National Health Insurance program. However, long-term maintenance HD is associated with physical inactivity and a low quality of life. As a result, exercise training is recommended to improve physiological adaptations and enhance functional capacity in HD patients. Supervised intradialytic exercise in clinical settings offers a safer and more progressive approach, leading to low dropout rates and better compliance.
Red blood cell dysfunction is a significant issue in ESRD, as impaired red blood cells can affect their deformability, aggregation, and oxygen transport capacity.
The purpose of this study is to establish reliable measurements of red blood cell function in HD patients and assess cardiovascular and muscular fitness, along with the effects of intradialytic exercise on these parameters.
- Conditions
- Hemodialysis Complication
- Being tested
- Supervised exercise training
- Keywords
- Hemodialysis, Exercise training, Erythrocyte, Rheology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exercise trainingBehavioural
Participants perform Intradialytic cycling exercise training in the hospital for 6 months (24 weeks) and 3 months (12 weeks) at home. Exercise prescription: 50-60% maximal workload for 20-30 minutes, including low intensity warm-up and cool down (30% of maximal workload).
| Study group | Role | What they receive |
|---|---|---|
| Supervised exercise training | Experimental | Not described Receives: Behavioral: Supervised exercise training |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deformability of erythrocytes
Red blood cells (RBCs) deformability refers to the cells' ability to adapt their shape to the dynamically changing flow conditions so as to minimize their resistance to flow.
Measured: 9 months
Aggregation of erythrocytes
Erythrocyte aggregation is the reversible clumping of red blood cells (RBCs) under low shear forces or at stasis.
Measured: 9 months
Secondary outcomes (2)
Cardiopulmonary fitness
ESRD patients performed cardiopulmonary exercise testing (CPET) to assess their aerobic capacity. CPET composed of continuous workload increment of 10 W/min until exhaustion (usually within 8-12 minutes). Oxygen consumption, carbon dioxide production, ventilation, respiratory rate would be recorded.
Measured: 9 months
Quality of life in ESRD patients
The investigators would use a qusionnaire, The Kidney Disease Quality of Life 36-item short form survey (KDQOL-36), to record and scale the qulaity of life in ESRD patients. The KDQOL-36 (Kidney Disease Quality of Life 36-Item Short Form Survey) measures the quality of life in kidney disease patients. It uses a score range from 0 to 100, where higher scores indicate better quality of life and lower scores indicate worse outcomes. Ensure to note this when reporting results to clarify that higher scores reflect fewer symptoms and better overall well-being.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start1 Aug 2022
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Why it stopped: The study was not initiated, and no participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong-Shyan Wang, Chang Gung Memorial Hospital
- Investigators
- Jong-Shyan Wang, PhD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575634
- Sponsor's protocol ID
- 202102279A3101
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 16 Sep 2026
- 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Supervised Exercise on Rheological Functions of Erythrocyte in Patients With End-Stage Renal Disease on Hemodialysis
- ClinicalTrials.gov ID
- NCT06575634
- Acronym / sponsor ID
- 202102279A3101
- Conditions
- Hemodialysis Complication
- Keywords
- Hemodialysis, Exercise training, Erythrocyte, Rheology
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not initiated, and no participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 28 Aug 2024 (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 improve aerobic capacity, muscular function, and health-related quality of life in patients with end-stage renal disease (ESRD), regular exercise is recommended. Supervised intradialytic exercise at moderate intensity is a viable approach to ensure patient safety, maintain compliance, and effectively enhance physiological adaptations. However, the impact of exercise training on erythrocyte rheological properties in ESRD patients, such as red blood cell deformability, aggregation, and oxygen transport capacity, remains unclear.
Method: ESRD patients (anticipated n=180) will undergo supervised exercise training therapy three times per week for six months in the hospital, followed by three months at home. Cardiopulmonary exercise tests will be conducted before and after the intervention. Erythrocyte deformability and aggregation will be assessed using a laser-assisted optical rotational cell analyzer (LORCA), while additional protein levels and reactive oxygen species (ROS) status will be measured using a flow cytometer. This will help determine how exercise affects the rheological properties of red blood cells in this population.
Detailed description
Renal dysfunction often stems from cardiovascular-related comorbidities or metabolic disorders, leading to the accumulation of excessive inflammatory products or damaging the bioenergetic health of red blood cells. This eventually contributes to the development of chronic kidney disease (CKD). At the most advanced stage, known as end-stage renal disease (ESRD), patients suffer from severe uremia and renal failure, necessitating renal replacement therapy, typically in the form of dialysis.
Hemodialysis (HD) is the most common treatment for ESRD patients, especially in Taiwan, which has the highest global prevalence of HD due to related chronic diseases and a comprehensive National Health Insurance program. However, long-term maintenance HD is associated with physical inactivity and a low quality of life. As a result, exercise training is recommended to improve physiological adaptations and enhance functional capacity in HD patients. Supervised intradialytic exercise in clinical settings offers a safer and more progressive approach, leading to low dropout rates and better compliance.
Red blood cell dysfunction is a significant issue in ESRD, as impaired red blood cells can affect their deformability, aggregation, and oxygen transport capacity.
The purpose of this study is to establish reliable measurements of red blood cell function in HD patients and assess cardiovascular and muscular fitness, along with the effects of intradialytic exercise on these parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised exercise training | Experimental | Behavioral: Supervised exercise training |
| Control group | No intervention | – |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Receiving hemodialysis and medication at least for 6 weeks
- Kt/V score > 1.2
Key exclusion criteria (6 listed)
- Under 20 years-old
- Hyperkalemia occurs within 3 month
- Having orthopedic or muscular diseases
- Other concerned medical, psychological or physiological diseases
- Pregnancy
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 |
|---|---|---|
| Supervised exercise trainingParticipants perform Intradialytic cycling exercise training in the hospital for 6 months (24 weeks) and 3 months (12 weeks) at home. Exercise prescription: 50-60% maximal workload for 20-30 minutes, including low intensity warm-up and cool down (30% of maximal workload). | Behavioural | Supervised exercise training |
Primary outcome
Deformability of erythrocytes
Time frame: 9 months
Red blood cells (RBCs) deformability refers to the cells' ability to adapt their shape to the dynamically changing flow conditions so as to minimize their resistance to flow.
Aggregation of erythrocytes
Time frame: 9 months
Erythrocyte aggregation is the reversible clumping of red blood cells (RBCs) under low shear forces or at stasis.
2 secondary outcomes
Cardiopulmonary fitness
Time frame: 9 months
Quality of life in ESRD patients
Time frame: 9 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Hemodialysis Complication
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
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.
Jong-Shyan Wang, PhD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised exercise training in people with Hemodialysis Complication, run by Chang Gung Memorial 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 6 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: withdrawn, as of the sponsor's last update on 16 Sep 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Deformability of erythrocytes (time frame: 9 months). The study lists 2 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 16 Sep 2026.