Exercise Therapy on Mitochondrial Functions of Lymphocyte in Hemodialysis

Hemodialysis Complication Clinical Trial

Official title:

Supervised Exercise Therapy on Mitochondrial Functions of Platelet and Lymphocyte in Patients With End-Stage Renal Disease on Hemodialysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06417307
• Other study ID #: 202002321A3C501
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: Chang Gung Memorial Hospital
• Contact: Jong-Shyan Wang, PhD
• Phone: +886-3-2118800
• Email: s5492[@]mail.cgu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemodialysis Complication

Intervention

Behavioral:
• Supervised exercise 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).
• Control group
Maintain daily lifestyle until the end of the study. Receive no intervention/supplements.

Locations

Country	Name	City	State
Taiwan	Chang Gung University	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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. eCollec — View Citation

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 2 — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	9 months
Secondary	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.	9 months
Secondary	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.	9 months