End-Stage Renal Disease Requiring HaemodialysisNCT07836881
Effects of Supervised Exercise Training on Erythrocyte Deformability in Hemodialysis Patients
A study testing Supervised Exercise Training in people with End-Stage Renal Disease Requiring Haemodialysis, run by Asia University at 1 site in Taiwan.
Trial summary
This study evaluated red blood cell function and aerobic capacity in adults receiving maintenance hemodialysis and in healthy reference participants. Participants receiving hemodialysis were included in either a supervised exercise training group or a usual-care group. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- End-Stage Renal Disease Requiring Haemodialysis
- 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
- 63 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Aug 2022to 28 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 20 years or older
- For participants with end-stage renal disease: maintenance hemodialysis for more than 6 months, clinically stable during the previous 3 months, stable medical treatment for at least 6 weeks, nephrologist approval for participation, and Kt/V >1.2.
- For healthy reference participants: no history of kidney disease.
- Willingness to provide written informed consent.
Who cannot join
- Hyperkalemia within the previous 3 months.
- Orthopedic disease, muscle weakness, or other medical, physiological, or psychological conditions preventing exercise training or exercise testing.
- Pregnancy or planned pregnancy within 1 year.
- Implanted cardiac devices that prevented achievement of the heart rate required for exercise training.
- Cardiovascular, metabolic, or other clinical contraindications to exercise testing or training.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Supervised Exercise Training on Red Blood Cell Membrane Protein-Regulated Deformability in Patients With End-Stage Renal Disease Receiving Hemodialysis
This study evaluated red blood cell function and aerobic capacity in adults receiving maintenance hemodialysis and in healthy reference participants. Participants receiving hemodialysis were included in either a supervised exercise training group or a usual-care group.
The supervised exercise program combined resistance and aerobic exercise performed before hemodialysis. Participants in the exercise group completed repeated assessments across a non-exercise observation period, exercise training, and post-training follow-up. The usual-care group continued usual care without supervised exercise training, and healthy participants served as a reference group.
Assessments included cardiopulmonary exercise testing and blood sampling to evaluate aerobic capacity, red blood cell deformability, and red blood cell characteristics related to membrane function, cell shape, oxidative stress, and calcium-related responses.
Read the detailed description
This prospective study included adults receiving maintenance hemodialysis and healthy reference participants. Participants receiving hemodialysis were included in a supervised exercise training group or a usual-care group. Healthy participants underwent reference assessments without exercise intervention.
Participants in the supervised exercise group first completed a non-exercise observation period and subsequently undertook supervised pre-dialysis exercise training combining resistance and aerobic exercise. Training was performed two to three times per week, with a target of 72 supervised sessions. Exercise sessions were performed approximately 1 to 2 hours before hemodialysis. Aerobic exercise was performed using a cycle ergometer, recumbent stepper, or treadmill, with exercise intensity prescribed according to cardiopulmonary exercise testing. Resistance exercises targeted the upper limbs, lower limbs, and trunk. Blood pressure and electrocardiographic monitoring were performed during exercise sessions.
Participants in the usual-care group continued their usual care without supervised exercise training.
Longitudinal assessments in the exercise group were conducted at study entry, after the non-exercise observation period, during training, after completion of training, and after cessation of training. Assessments included cardiopulmonary exercise testing and blood sampling. Red blood cell analyses included osmotic and mechanical deformability and selected cellular characteristics related to membrane function, cell shape, oxidative stress, and intracellular calcium responses. Healthy participants provided reference data for corresponding physiological and erythrocyte measurements.
- Being tested
- Supervised Exercise Training
- Keywords
- Exercise Training, Hemodialysis, Red Blood Cell, Aerobic Capacity, Erythrocyte Deformability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Exercise TrainingBehavioural
Supervised pre-dialysis exercise training combining aerobic and resistance exercise was performed two to three times per week. Each session included aerobic exercise using a cycle ergometer, recumbent stepper, or treadmill, together with resistance exercises targeting the upper limbs, lower limbs, and trunk. Exercise intensity was prescribed according to cardiopulmonary exercise testing and adjusted according to participant tolerance and clinical status. Training was conducted approximately 1 to 2 hours before hemodialysis, with a target of 72 supervised exercise sessions.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Exercise Training | Experimental | Participants receiving maintenance hemodialysis underwent supervised pre-dialysis exercise training combining aerobic and resistance exercise. Training was performed two to three times per week, with a target of 72 supervised sessions. Receives: Behavioral: Supervised Exercise Training |
| Usual Care | No intervention | Participants receiving maintenance hemodialysis continued usual medical care and maintained their usual daily activities without supervised exercise training during the intervention period. |
| Healthy Reference | No intervention | Healthy participants without kidney disease received no exercise intervention and underwent study assessments to provide reference data for physiological and red blood cell measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximal Erythrocyte Elongation Index (EImax)
Maximal erythrocyte elongation index (EImax) was derived from ektacytometry measurements obtained across increasing shear stress.
Measured: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
Change in Shear Stress at One-Half Maximal Erythrocyte Deformation (SS1/2)
The shear stress required to achieve one-half of maximal erythrocyte deformation (SS1/2) was derived from ektacytometry measurements across increasing shear stress.
Measured: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
Change in Hypertonic Osmolality at 50% of Maximal Elongation Index (Ohyper)
Ohyper was assessed by osmotic-gradient ektacytometry and defined as the hypertonic osmolality at 50% of maximal erythrocyte elongation index.
Measured: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
Change in Osmolality at Maximal Elongation Index (Omax)
Omax was assessed by osmotic-gradient ektacytometry and defined as the osmolality at maximal erythrocyte elongation index.
Measured: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
Change in Osmoscan Area Under the Elongation Index-Osmolality Curve
Osmoscan area was assessed by osmotic-gradient ektacytometry and defined as the area under the erythrocyte elongation index-osmolality curve.
Measured: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
Secondary outcomes (5)
Change in Peak Oxygen Uptake (Peak VO₂/kg) Assessed by Cardiopulmonary Exercise Testing
Peak oxygen uptake normalized to body mass (mL/kg/min) was measured during symptom-limited cardiopulmonary exercise testing.
Measured: Baseline; 3 months after baseline; after 36 supervised exercise sessions (mid-training); after 72 supervised exercise sessions (end of training); and 3 months after training cessation
Change in Erythrocyte Cellular Characteristics
Red blood cell cellular and membrane-related characteristics were assessed using laboratory-based methods.
Measured: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
Change in Gardos-Related Erythrocyte Deformability Response
Gardos-related erythrocyte deformability response was assessed by ektacytometry under calcium-dependent challenge conditions.
Measured: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
Change in Erythrocyte Intracellular Calcium Response to Oxidative Stress
Erythrocyte intracellular calcium response to oxidative stress was assessed using Fluo-4 fluorescence and flow cytometry.
Measured: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
Change in Erythrocyte Side-Scatter Response to Oxidative Stress
Erythrocyte side-scatter response to oxidative stress was assessed by flow cytometry.
Measured: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start24 Aug 2022
- Primary completion28 Dec 2025
- Study completion28 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Renal Disease Requiring HaemodialysisStudies 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asia University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, Yu-Chieh Huang, Asia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836881
- Sponsor's protocol ID
- 202102279A3
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2026
- Last updated
- 23 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Supervised Exercise Training on Red Blood Cell Membrane Protein-Regulated Deformability in Patients With End-Stage Renal Disease Receiving Hemodialysis
- ClinicalTrials.gov ID
- NCT07836881
- Acronym / sponsor ID
- 202102279A3
- Keywords
- Exercise Training, Hemodialysis, Red Blood Cell, Aerobic Capacity, Erythrocyte Deformability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Asia UniversityUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 28 Dec 2025 (actual)
- Study completion
- 28 Dec 2025 (actual)
- First posted
- 23 Sep 2026 (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.
This study evaluated red blood cell function and aerobic capacity in adults receiving maintenance hemodialysis and in healthy reference participants. Participants receiving hemodialysis were included in either a supervised exercise training group or a usual-care group.
The supervised exercise program combined resistance and aerobic exercise performed before hemodialysis. Participants in the exercise group completed repeated assessments across a non-exercise observation period, exercise training, and post-training follow-up. The usual-care group continued usual care without supervised exercise training, and healthy participants served as a reference group.
Assessments included cardiopulmonary exercise testing and blood sampling to evaluate aerobic capacity, red blood cell deformability, and red blood cell characteristics related to membrane function, cell shape, oxidative stress, and calcium-related responses.
Detailed description
This prospective study included adults receiving maintenance hemodialysis and healthy reference participants. Participants receiving hemodialysis were included in a supervised exercise training group or a usual-care group. Healthy participants underwent reference assessments without exercise intervention.
Participants in the supervised exercise group first completed a non-exercise observation period and subsequently undertook supervised pre-dialysis exercise training combining resistance and aerobic exercise. Training was performed two to three times per week, with a target of 72 supervised sessions. Exercise sessions were performed approximately 1 to 2 hours before hemodialysis. Aerobic exercise was performed using a cycle ergometer, recumbent stepper, or treadmill, with exercise intensity prescribed according to cardiopulmonary exercise testing. Resistance exercises targeted the upper limbs, lower limbs, and trunk. Blood pressure and electrocardiographic monitoring were performed during exercise sessions.
Participants in the usual-care group continued their usual care without supervised exercise training.
Longitudinal assessments in the exercise group were conducted at study entry, after the non-exercise observation period, during training, after completion of training, and after cessation of training. Assessments included cardiopulmonary exercise testing and blood sampling. Red blood cell analyses included osmotic and mechanical deformability and selected cellular characteristics related to membrane function, cell shape, oxidative stress, and intracellular calcium responses. Healthy participants provided reference data for corresponding physiological and erythrocyte measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Supervised Exercise Training | Experimental | Behavioral: Supervised Exercise TrainingParticipants receiving maintenance hemodialysis underwent supervised pre-dialysis exercise training combining aerobic and resistance exercise. Training was performed two to three times per week, with a target of 72 supervised sessions. |
| Usual Care | No intervention | –Participants receiving maintenance hemodialysis continued usual medical care and maintained their usual daily activities without supervised exercise training during the intervention period. |
| Healthy Reference | No intervention | –Healthy participants without kidney disease received no exercise intervention and underwent study assessments to provide reference data for physiological and red blood cell measurements. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20 years or older
- For participants with end-stage renal disease: maintenance hemodialysis for more than 6 months, clinically stable during the previous 3 months, stable medical treatment for at least 6 weeks, nephrologist approval for participation, and Kt/V >1.2.
- For healthy reference participants: no history of kidney disease.
- Willingness to provide written informed consent.
Key exclusion criteria (5 listed)
- Hyperkalemia within the previous 3 months.
- Orthopedic disease, muscle weakness, or other medical, physiological, or psychological conditions preventing exercise training or exercise testing.
- Pregnancy or planned pregnancy within 1 year.
- Implanted cardiac devices that prevented achievement of the heart rate required for exercise training.
- Cardiovascular, metabolic, or other clinical contraindications to exercise testing or training.
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 TrainingSupervised pre-dialysis exercise training combining aerobic and resistance exercise was performed two to three times per week. Each session included aerobic exercise using a cycle ergometer, recumbent stepper, or treadmill, together with resistance exercises targeting the upper limbs, lower limbs, and trunk. Exercise intensity was prescribed according to cardiopulmonary exercise testing and adjusted according to participant tolerance and clinical status. Training was conducted approximately 1 to 2 hours before hemodialysis, with a target of 72 supervised exercise sessions. | Behavioural | Supervised Exercise Training |
Primary outcome
Change in Maximal Erythrocyte Elongation Index (EImax)
Time frame: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
Maximal erythrocyte elongation index (EImax) was derived from ektacytometry measurements obtained across increasing shear stress.
Change in Shear Stress at One-Half Maximal Erythrocyte Deformation (SS1/2)
Time frame: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
The shear stress required to achieve one-half of maximal erythrocyte deformation (SS1/2) was derived from ektacytometry measurements across increasing shear stress.
Change in Hypertonic Osmolality at 50% of Maximal Elongation Index (Ohyper)
Time frame: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
Ohyper was assessed by osmotic-gradient ektacytometry and defined as the hypertonic osmolality at 50% of maximal erythrocyte elongation index.
Change in Osmolality at Maximal Elongation Index (Omax)
Time frame: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
Omax was assessed by osmotic-gradient ektacytometry and defined as the osmolality at maximal erythrocyte elongation index.
Change in Osmoscan Area Under the Elongation Index-Osmolality Curve
Time frame: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
Osmoscan area was assessed by osmotic-gradient ektacytometry and defined as the area under the erythrocyte elongation index-osmolality curve.
5 secondary outcomes
Change in Peak Oxygen Uptake (Peak VO₂/kg) Assessed by Cardiopulmonary Exercise Testing
Time frame: Baseline; 3 months after baseline; after 36 supervised exercise sessions (mid-training); after 72 supervised exercise sessions (end of training); and 3 months after training cessation
Change in Erythrocyte Cellular Characteristics
Time frame: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
Change in Gardos-Related Erythrocyte Deformability Response
Time frame: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
Change in Erythrocyte Intracellular Calcium Response to Oxidative Stress
Time frame: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
Change in Erythrocyte Side-Scatter Response to Oxidative Stress
Time frame: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation
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 23 Sep 2026.
- 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.
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 End-Stage Renal Disease Requiring Haemodialysis, run by Asia University 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 4 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 23 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 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 in Maximal Erythrocyte Elongation Index (EImax) (time frame: Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation). The study lists 5 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 23 Sep 2026.