- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06417307
Exercise Therapy on Mitochondrial Functions of Lymphocyte in Hemodialysis
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jong-Shyan Wang, PhD
- Phone Number: 5748 +886-3-2118800
- Email: s5492@mail.cgu.edu.tw
Study Locations
-
-
-
Taoyuan, Taiwan, 333
- Recruiting
- Chang Gung University
-
Contact:
- Jong-Shyan Wang, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Under 20 years-old, hyperkalemia occurs within 3 month, orthopedic or muscular diseases, other medical, psychological or physiological diseases, pregnancy exercise contraindications.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Supervised exercise training
Moderate intensity continuous cycling training.
|
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).
|
Experimental: Control group
Recieve no intervention but only maintain daily lifestyle.
|
Maintain daily lifestyle until the end of the study.
Receive no intervention/supplements.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiopulmonary fitness
Time Frame: 9 months
|
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.
|
9 months
|
Quality of life in ESRD patients
Time Frame: 9 months
|
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.
|
9 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jong-Shyan Wang, PhD, Chang Gung Memorial Hospital
Publications and helpful links
General 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.
- Altintas 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.
- Deligiannis 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.
- Chou 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.
- Lopes 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 202002321A3C501
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hemodialysis Complication
-
National Taiwan University HospitalCompletedHemodialysis Complication | Hemodialysis-Induced SymptomTaiwan
-
Eurofarma Laboratorios S.A.Completed
-
Universitaire Ziekenhuizen KU LeuvenNIPROCompletedHemodialysis ComplicationBelgium
-
Carlo Maria GuastoniUnknown
-
nooshin daliliCompletedHemodialysis Complication
-
Saint-Joseph UniversityTerminated
-
Fresenius Kabi Taiwan Ltd.Chung Shan Medical UniversityCompleted
-
Assiut UniversityNot yet recruitingHemodialysis Complication
-
RenJi HospitalNot yet recruitingHemodialysis Complication
-
Cairo UniversityCompletedHemodialysis ComplicationEgypt
Clinical Trials on Supervised exercise training
-
University of ManchesterUnknownCardiovascular Diseases | Peripheral Arterial Disease
-
Medical University of ViennaUnknownPeripheral Artery DiseaseAustria
-
Chang Gung Memorial HospitalCompleted
-
Paracelsus Medical UniversityLudwig Boltzmann Institute for Digital Health and PreventionCompleted
-
University of Central ArkansasCompletedDiabetes Mellitus, Type 2United States
-
Rigshospitalet, DenmarkUnknownIntermittent ClaudicationDenmark
-
Sheffield Teaching Hospitals NHS Foundation TrustSheffield Hallam UniversityCompletedCardiovascular Disease | Aneurysm | Aortic Aneurysm, Abdominal | Vascular Disease | Aortic DiseaseUnited Kingdom
-
University of Colorado, DenverAmerican Diabetes AssociationCompleted
-
Université de SherbrookeCompleted
-
University of VermontCompletedCancer ThrombosisUnited States