Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575634
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Exercise Therapy on Rheological Functions of Erythrocyte in Hemodialysis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Supervised Exercise on Rheological Functions of Erythrocyte in Patients With End-Stage Renal Disease on Hemodialysis
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 at moderate intensity is a viable approach to ensure patient safety maintain compliance and effectively enhance physiological adaptations However the impact of exercise training on erythrocyte rheological properties in ESRD patients such as red blood cell deformability aggregation and oxygen transport capacity remains unclear
Method ESRD patients anticipated n180 will undergo supervised exercise training therapy three times per week for six months in the hospital followed by three months at home Cardiopulmonary exercise tests will be conducted before and after the intervention Erythrocyte deformability and aggregation will be assessed using a laser-assisted optical rotational cell analyzer LORCA while additional protein levels and reactive oxygen species ROS status will be measured using a flow cytometer This will help determine how exercise affects the rheological properties of red blood cells in this population
Method ESRD patients anticipated n180 will undergo supervised exercise training therapy three times per week for six months in the hospital followed by three months at home Cardiopulmonary exercise tests will be conducted before and after the intervention Erythrocyte deformability and aggregation will be assessed using a laser-assisted optical rotational cell analyzer LORCA while additional protein levels and reactive oxygen species ROS status will be measured using a flow cytometer This will help determine how exercise affects the rheological properties of red blood cells in this population
Detailed Description:
Renal dysfunction often stems from cardiovascular-related comorbidities or metabolic disorders leading to the accumulation of excessive inflammatory products or damaging the bioenergetic health of red blood cells This eventually contributes to the development of chronic kidney disease CKD At the most advanced stage known as end-stage renal disease ESRD patients suffer from severe uremia and renal failure necessitating renal replacement therapy typically in the form of dialysis
Hemodialysis HD is the most common treatment for ESRD patients especially in Taiwan which has the highest global prevalence of HD due to related chronic diseases and a comprehensive National Health Insurance program However long-term maintenance HD is associated with physical inactivity and a low quality of life As a result exercise training is recommended to improve physiological adaptations and enhance functional capacity in HD patients Supervised intradialytic exercise in clinical settings offers a safer and more progressive approach leading to low dropout rates and better compliance
Red blood cell dysfunction is a significant issue in ESRD as impaired red blood cells can affect their deformability aggregation and oxygen transport capacity
The purpose of this study is to establish reliable measurements of red blood cell function in HD patients and assess cardiovascular and muscular fitness along with the effects of intradialytic exercise on these parameters
Hemodialysis HD is the most common treatment for ESRD patients especially in Taiwan which has the highest global prevalence of HD due to related chronic diseases and a comprehensive National Health Insurance program However long-term maintenance HD is associated with physical inactivity and a low quality of life As a result exercise training is recommended to improve physiological adaptations and enhance functional capacity in HD patients Supervised intradialytic exercise in clinical settings offers a safer and more progressive approach leading to low dropout rates and better compliance
Red blood cell dysfunction is a significant issue in ESRD as impaired red blood cells can affect their deformability aggregation and oxygen transport capacity
The purpose of this study is to establish reliable measurements of red blood cell function in HD patients and assess cardiovascular and muscular fitness along with the effects of intradialytic exercise on these parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None