Exercise Therapy on Rheological Functions of Erythrocyte in Hemodialysis

NCT06575634 | Recruiting

• 1 other identifier: 202102279A3101
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Complication

Keywords

Hemodialysis; Exercise training; Erythrocyte; Rheology

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Cardiopulmonary fitness

  9 months

• Quality of life in ESRD patients

  9 months

Study Arms (2)

Supervised exercise training

EXPERIMENTAL

Behavioral: Supervised exercise training

Control group

NO INTERVENTION

Interventions

Supervised exercise training BEHAVIORAL

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).

Supervised exercise training

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

RECRUITING

Study Officials

• Jong-Shyan Wang, PhD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jong-Shyan Wang, PhD

CONTACT

+886-3-2118800; s5492@mail.cgu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 28, 2024
• Study Start: August 1, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)