Hemodialysis ComplicationPhase 3NCT06417307
Exercise on Mitochondrial Functions of Lymphocyte in Hemodialysis
A Phase 3 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 with moderate intensity is an available approach to maintain patients' safety and compliance, and enhance physiological… 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
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2021to 31 Jul 2024
- Phase
- Phase 3
- 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
- All patients have been receiving hemodialysis and medication at least for 6 weeks, the Kt/V score must be above 1.2 to show that they were stable.
Who cannot join
- Under 20 years-old, hyperkalemia occurs within 3 month, orthopedic or muscular diseases, other medical, psychological or physiological diseases, pregnancy exercise contraindications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supervised Exercise Therapy on Mitochondrial Functions of Platelet and Lymphocyte 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 with moderate intensity is an available approach to maintain patients' safety and compliance, and enhance physiological adaptations effectively. The exercise training effects of mitochondrial functions of lymphocyte in ESRD patients, like respiratory capacity, bioenergetic status and thrombosis/immunological regulation remained unclear.
Method: ESRD patients (anticipated n=180) would conduct supervised exercise training therapy for 3 days a week for 6 months in the hospital and 3 months at home. Cardiopulmonary exercise therapy would be performed before and after the intervention. A high resolution respirometer and a flow cytometer are used to determine the oxygen consumption rate/mitochondrial respiration in mitochondria and subtypes of lymphocyte, respectively.
Read the detailed description
Renal dysfunction results from cardiovascular-related comorbidities or metabolic disorders, accumulating excessive inflammatory products or damage mitochondrial bioenergetics health in platelet and lymphocyte, then lead to chronic kidney disease (CKD) eventually. End-stage renal disease (ESRD) is the highest level of CKD, patients at ESRD stage suffer from severe uremia and renal failure, preparing renal replacement therapy: dialysis.
Hemodialysis (HD) are the most common treatment for ESRD patients, especially in Taiwan, where reports the highest prevalence of HD globally due to related chronic diseases and comprehensive National Health Insurance program. Maintenance (long-term) HD results in physical inactivity and low quality of life; thus, exercise training is recommended to improve physiological adaptations and functional capacity for HD patients. With supervised condition and a safer progression, intradialytic exercise in clinical settings provides low dropout rate and superior compliance.
Mitochondrial dysfunction is one of the concerned issues in ESRD, impaired mitochondria also dysregulate circulating lymphocyte, leading to immunological senescence .
The purposes of the present study are to establish the measurements of mitochondrial functions of platelet and lymphocyte in HD patients, and determine cardiovascular and muscular fitness along with the effects of intradialytic exercise.
- Conditions
- Hemodialysis Complication
- Being tested
- Supervised exercise training, Control group
- Keywords
- Hemodialysis, Mitochondria, Lymphocyte, Exercise training
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).
Control groupBehavioural
Maintain daily lifestyle until the end of the study. Receive no intervention/supplements.
| Study group | Role | What they receive |
|---|---|---|
| Supervised exercise training | Experimental | Moderate intensity continuous cycling training. Receives: Behavioral: Supervised exercise training |
| Control group | Experimental | Recieve no intervention but only maintain daily lifestyle. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitochondrial function of lymphocyte
Evaluate oxygen consumption rate (oxidative phophorylation/electron transport chain), bioenergetic health index (BHI) in lymphocyte by using a high resolution respirometer.
Evaluate mitochondrial function and subtypes of lymphocyte by using a aflow cytometer.
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
We would use a qusionnaire named ESRDkidney disease quality of life-36 (KDQOL-36) to record and scale the qulaity of life in ESRD patients. The content include work status, cognitive funtion, social support, physical functioning and so on.
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 posted16 May 2024
- Study start1 Aug 2021
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 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
- NCT06417307
- Sponsor's protocol ID
- 202002321A3C501
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sovatzidis A, Chatzinikolaou A, Fatouros IG, Panagoutsos S, Draganidis D, Nikolaidou E, Avloniti A, Michailidis Y, Mantzouridis I, Batrakoulis A, Pasadakis P, Vargemezis V. Intradialytic Cardiovascular Exercise Training Alters Redox Status, Reduces Inflammation and Improves Physical Performance in Patients with Chronic Kidney Disease. Antioxidants (Basel). 2020 Sep 15;9(9):868. doi: 10.3390/antiox9090868.
PubMed 32942555Altintas MM, DiBartolo S, Tadros L, Samelko B, Wasse H. Metabolic Changes in Peripheral Blood Mononuclear Cells Isolated From Patients With End Stage Renal Disease. Front Endocrinol (Lausanne). 2021 Mar 9;12:629239. doi: 10.3389/fendo.2021.629239. eCollection 2021.
PubMed 33790861Deligiannis A, D'Alessandro C, Cupisti A. Exercise training in dialysis patients: impact on cardiovascular and skeletal muscle health. Clin Kidney J. 2021 Jan 11;14(Suppl 2):ii25-ii33. doi: 10.1093/ckj/sfaa273. eCollection 2021 Apr.
PubMed 33981417Chou CH, Fu TC, Tsai HH, Hsu CC, Wang CH, Wang JS. High-intensity interval training enhances mitochondrial bioenergetics of platelets in patients with heart failure. Int J Cardiol. 2019 Jan 1;274:214-220. doi: 10.1016/j.ijcard.2018.07.104. Epub 2018 Jul 27.
PubMed 30072155Lopes LCC, Mota JF, Prestes J, Schincaglia RM, Silva DM, Queiroz NP, Freitas ATVS, Lira FS, Peixoto MDRG. Intradialytic Resistance Training Improves Functional Capacity and Lean Mass Gain in Individuals on Hemodialysis: A Randomized Pilot Trial. Arch Phys Med Rehabil. 2019 Nov;100(11):2151-2158. doi: 10.1016/j.apmr.2019.06.006. Epub 2019 Jul 3.
PubMed 31278924Lin YT, Huang SC, Peng SC, Hsiao CC, Fang JT, Wang JS. Pre-hemodialysis exercise training improves systemic aerobic capacity and platelet bioenergetic efficiency in patients with end-stage renal disease. Life Sci. 2026 Jul 1;396:124403. doi: 10.1016/j.lfs.2026.124403. Epub 2026 Apr 18.
PubMed 42009192
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supervised Exercise Therapy on Mitochondrial Functions of Platelet and Lymphocyte in Patients With End-Stage Renal Disease on Hemodialysis
- ClinicalTrials.gov ID
- NCT06417307
- Acronym / sponsor ID
- 202002321A3C501
- Conditions
- Hemodialysis Complication
- Keywords
- Hemodialysis, Mitochondria, Lymphocyte, Exercise training
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 16 May 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 with moderate intensity is an available approach to maintain patients' safety and compliance, and enhance physiological adaptations effectively. The exercise training effects of mitochondrial functions of lymphocyte in ESRD patients, like respiratory capacity, bioenergetic status and thrombosis/immunological regulation remained unclear.
Method: ESRD patients (anticipated n=180) would conduct supervised exercise training therapy for 3 days a week for 6 months in the hospital and 3 months at home. Cardiopulmonary exercise therapy would be performed before and after the intervention. A high resolution respirometer and a flow cytometer are used to determine the oxygen consumption rate/mitochondrial respiration in mitochondria and subtypes of lymphocyte, respectively.
Detailed description
Renal dysfunction results from cardiovascular-related comorbidities or metabolic disorders, accumulating excessive inflammatory products or damage mitochondrial bioenergetics health in platelet and lymphocyte, then lead to chronic kidney disease (CKD) eventually. End-stage renal disease (ESRD) is the highest level of CKD, patients at ESRD stage suffer from severe uremia and renal failure, preparing renal replacement therapy: dialysis.
Hemodialysis (HD) are the most common treatment for ESRD patients, especially in Taiwan, where reports the highest prevalence of HD globally due to related chronic diseases and comprehensive National Health Insurance program. Maintenance (long-term) HD results in physical inactivity and low quality of life; thus, exercise training is recommended to improve physiological adaptations and functional capacity for HD patients. With supervised condition and a safer progression, intradialytic exercise in clinical settings provides low dropout rate and superior compliance.
Mitochondrial dysfunction is one of the concerned issues in ESRD, impaired mitochondria also dysregulate circulating lymphocyte, leading to immunological senescence .
The purposes of the present study are to establish the measurements of mitochondrial functions of platelet and lymphocyte in HD patients, and determine cardiovascular and muscular fitness along with the effects of intradialytic exercise.
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 trainingModerate intensity continuous cycling training. |
| Control group | Experimental | Behavioral: Control groupRecieve no intervention but only maintain daily lifestyle. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients have been receiving hemodialysis and medication at least for 6 weeks, the Kt/V score must be above 1.2 to show that they were stable.
Key exclusion criteria (1 listed)
- Under 20 years-old, hyperkalemia occurs within 3 month, orthopedic or muscular diseases, other medical, psychological or physiological diseases, pregnancy exercise contraindications.
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 |
| Control groupMaintain daily lifestyle until the end of the study. Receive no intervention/supplements. | Behavioural | Control group |
Primary outcome
Mitochondrial function of lymphocyte
Time frame: 9 months
Evaluate oxygen consumption rate (oxidative phophorylation/electron transport chain), bioenergetic health index (BHI) in lymphocyte by using a high resolution respirometer. Evaluate mitochondrial function and subtypes of lymphocyte by using a aflow cytometer.
2 secondary outcomes
Cardiopulmonary fitness
Time frame: 9 months
Quality of life in ESRD patients
Time frame: 9 months
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 4 Apr 2025.
- Background: PubMed 32942555Sovatzidis A, Chatzinikolaou A, Fatouros IG, Panagoutsos S, Draganidis D, Nikolaidou E, Avloniti A, Michailidis Y, Mantzouridis I, Batrakoulis A, Pasadakis P, Vargemezis V. Intradialytic Cardiovascular Exercise Training Alters Redox Status, Reduces Inflammation and Improves Physical Performance in Patients with Chronic Kidney Disease. Antioxidants (Basel). 2020 Sep 15;9(9):868. doi: 10.3390/antiox9090868.
- Results publication: PubMed 33790861Altintas MM, DiBartolo S, Tadros L, Samelko B, Wasse H. Metabolic Changes in Peripheral Blood Mononuclear Cells Isolated From Patients With End Stage Renal Disease. Front Endocrinol (Lausanne). 2021 Mar 9;12:629239. doi: 10.3389/fendo.2021.629239. eCollection 2021.
- Results publication: PubMed 33981417Deligiannis A, D'Alessandro C, Cupisti A. Exercise training in dialysis patients: impact on cardiovascular and skeletal muscle health. Clin Kidney J. 2021 Jan 11;14(Suppl 2):ii25-ii33. doi: 10.1093/ckj/sfaa273. eCollection 2021 Apr.
- Results publication: PubMed 30072155Chou CH, Fu TC, Tsai HH, Hsu CC, Wang CH, Wang JS. High-intensity interval training enhances mitochondrial bioenergetics of platelets in patients with heart failure. Int J Cardiol. 2019 Jan 1;274:214-220. doi: 10.1016/j.ijcard.2018.07.104. Epub 2018 Jul 27.
- Results publication: PubMed 31278924Lopes LCC, Mota JF, Prestes J, Schincaglia RM, Silva DM, Queiroz NP, Freitas ATVS, Lira FS, Peixoto MDRG. Intradialytic Resistance Training Improves Functional Capacity and Lean Mass Gain in Individuals on Hemodialysis: A Randomized Pilot Trial. Arch Phys Med Rehabil. 2019 Nov;100(11):2151-2158. doi: 10.1016/j.apmr.2019.06.006. Epub 2019 Jul 3.
- Derived from this study: PubMed 42009192Lin YT, Huang SC, Peng SC, Hsiao CC, Fang JT, Wang JS. Pre-hemodialysis exercise training improves systemic aerobic capacity and platelet bioenergetic efficiency in patients with end-stage renal disease. Life Sci. 2026 Jul 1;396:124403. doi: 10.1016/j.lfs.2026.124403. Epub 2026 Apr 18.
- 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.
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 Phase 3 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 1 inclusion and 1 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 4 Apr 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mitochondrial function of lymphocyte (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06417307, which also lists 6 linked publications.
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 4 Apr 2025.