Clinical trial NCT06575634: Exercise Therapy on Rheological Functions of Erythrocyte in Hemodialysis
Official title: Effects of Supervised Exercise on Rheological Functions of Erythrocyte in Patients With End-Stage Renal Disease on Hemodialysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemodialysis Complication
Keywords: Hemodialysis
Exercise training
Erythrocyte
Rheology
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 n=180) 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.

Eligibility criteria: Inclusion Criteria:

* Receiving hemodialysis and medication at least for 6 weeks
* Kt/V score \> 1.2

Exclusion Criteria:

* Under 20 years-old
* Hyperkalemia occurs within 3 month
* Having orthopedic or muscular diseases
* Other concerned medical, psychological or physiological diseases
* Pregnancy
* Other exercise contraindications

Primary outcomes:
measure: Deformability of erythrocytes
timeFrame: 9 months
measure: Aggregation of erythrocytes
timeFrame: 9 months
Secondary outcomes:
measure: Cardiopulmonary fitness
timeFrame: 9 months
measure: Quality of life in ESRD patients
timeFrame: 9 months
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Jong-Shyan Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: