Viewing Study NCT06417307



Ignite Creation Date: 2024-05-19 @ 5:33 PM
Last Modification Date: 2024-10-26 @ 3:29 PM
Study NCT ID: NCT06417307
Status: RECRUITING
Last Update Posted: 2024-05-16
First Post: 2024-05-13

Brief Title: Exercise Therapy on Mitochondrial Functions of Lymphocyte in Hemodialysis
Sponsor: Chang Gung Memorial Hospital
Organization: Chang Gung Memorial Hospital

Study Overview

Official Title: Supervised Exercise Therapy on Mitochondrial Functions of Platelet and Lymphocyte in Patients With End-Stage Renal Disease on Hemodialysis
Status: RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 thrombosisimmunological regulation remained unclear

Method ESRD patients anticipated n180 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 ratemitochondrial 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None