Exercise Therapy on Rheological Functions of Erythrocyte in Hemodialysis

Effects of Supervised Exercise on Rheological Functions of Erythrocyte 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 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.

Study Overview

• Status: Recruiting
• Conditions: Hemodialysis Complication
• Intervention / Treatment: Behavioral: Supervised exercise training

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• 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

• Taiwan
  • 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: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Supervised exercise training	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deformability of erythrocytes	Red blood cells (RBCs) deformability refers to the cells' ability to adapt their shape to the dynamically changing flow conditions so as to minimize their resistance to flow.	9 months
Aggregation of erythrocytes	Erythrocyte aggregation is the reversible clumping of red blood cells (RBCs) under low shear forces or at stasis.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Quality of life in ESRD patients	The investigators would use a qusionnaire, The Kidney Disease Quality of Life 36-item short form survey (KDQOL-36), to record and scale the qulaity of life in ESRD patients. The KDQOL-36 (Kidney Disease Quality of Life 36-Item Short Form Survey) measures the quality of life in kidney disease patients. It uses a score range from 0 to 100, where higher scores indicate better quality of life and lower scores indicate worse outcomes. Ensure to note this when reporting results to clarify that higher scores reflect fewer symptoms and better overall well-being.	9 months

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Jong-Shyan Wang, PhD, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Exercise training; Hemodialysis; Rheology; Erythrocyte
• Other Study ID Numbers: 202102279A3101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No