Effects of Supervised Exercise Training on Erythrocyte Deformability in Hemodialysis Patients

NCT07836881 | Completed

• 1 other identifier: 202102279A3
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated red blood cell function and aerobic capacity in adults receiving maintenance hemodialysis and in healthy reference participants. Participants receiving hemodialysis were included in either a supervised exercise training group or a usual-care group. The supervised exercise program combined resistance and aerobic exercise performed before hemodialysis. Participants in the exercise group completed repeated assessments across a non-exercise observation period, exercise training, and post-training follow-up. The usual-care group continued usual care without supervised exercise training, and healthy participants served as a reference group. Assessments included cardiopulmonary exercise testing and blood sampling to evaluate aerobic capacity, red blood cell deformability, and red blood cell characteristics related to membrane function, cell shape, oxidative stress, and calcium-related responses.

Conditions

End-Stage Renal Disease Requiring Haemodialysis

Keywords

Exercise Training; Hemodialysis; Red Blood Cell; Aerobic Capacity; Erythrocyte Deformability

Outcome Measures

Primary Outcomes (5)

• Change in Maximal Erythrocyte Elongation Index (EImax)

  Maximal erythrocyte elongation index (EImax) was derived from ektacytometry measurements obtained across increasing shear stress.

  Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation

• Change in Shear Stress at One-Half Maximal Erythrocyte Deformation (SS1/2)

  The shear stress required to achieve one-half of maximal erythrocyte deformation (SS1/2) was derived from ektacytometry measurements across increasing shear stress.

  Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation

• Change in Hypertonic Osmolality at 50% of Maximal Elongation Index (Ohyper)

  Ohyper was assessed by osmotic-gradient ektacytometry and defined as the hypertonic osmolality at 50% of maximal erythrocyte elongation index.

  Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation

• Change in Osmolality at Maximal Elongation Index (Omax)

  Omax was assessed by osmotic-gradient ektacytometry and defined as the osmolality at maximal erythrocyte elongation index.

  Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation

• Change in Osmoscan Area Under the Elongation Index-Osmolality Curve

  Osmoscan area was assessed by osmotic-gradient ektacytometry and defined as the area under the erythrocyte elongation index-osmolality curve.

  Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation

Secondary Outcomes (5)

• Change in Peak Oxygen Uptake (Peak VO₂/kg) Assessed by Cardiopulmonary Exercise Testing

  Baseline; 3 months after baseline; after 36 supervised exercise sessions (mid-training); after 72 supervised exercise sessions (end of training); and 3 months after training cessation

• Change in Erythrocyte Cellular Characteristics

  Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation

• Change in Gardos-Related Erythrocyte Deformability Response

  Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation

• Change in Erythrocyte Intracellular Calcium Response to Oxidative Stress

  Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation

• Change in Erythrocyte Side-Scatter Response to Oxidative Stress

  Baseline (study entry); 3 months after baseline (pre-training); mid-training after 36 supervised exercise sessions; end of training after 72 supervised exercise sessions; and 3 months after training cessation

Study Arms (3)

Supervised Exercise Training

EXPERIMENTAL

Participants receiving maintenance hemodialysis underwent supervised pre-dialysis exercise training combining aerobic and resistance exercise. Training was performed two to three times per week, with a target of 72 supervised sessions.

Behavioral: Supervised Exercise Training

Usual Care

NO INTERVENTION

Participants receiving maintenance hemodialysis continued usual medical care and maintained their usual daily activities without supervised exercise training during the intervention period.

Healthy Reference

NO INTERVENTION

Healthy participants without kidney disease received no exercise intervention and underwent study assessments to provide reference data for physiological and red blood cell measurements.

Interventions

Supervised Exercise Training BEHAVIORAL

Supervised pre-dialysis exercise training combining aerobic and resistance exercise was performed two to three times per week. Each session included aerobic exercise using a cycle ergometer, recumbent stepper, or treadmill, together with resistance exercises targeting the upper limbs, lower limbs, and trunk. Exercise intensity was prescribed according to cardiopulmonary exercise testing and adjusted according to participant tolerance and clinical status. Training was conducted approximately 1 to 2 hours before hemodialysis, with a target of 72 supervised exercise sessions.

Supervised Exercise Training

Eligibility Criteria

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

You may qualify if:

• Age 20 years or older
• For participants with end-stage renal disease: maintenance hemodialysis for more than 6 months, clinically stable during the previous 3 months, stable medical treatment for at least 6 weeks, nephrologist approval for participation, and Kt/V \>1.2.
• For healthy reference participants: no history of kidney disease.
• Willingness to provide written informed consent.

You may not qualify if:

• Hyperkalemia within the previous 3 months.
• Orthopedic disease, muscle weakness, or other medical, physiological, or psychological conditions preventing exercise training or exercise testing.
• Pregnancy or planned pregnancy within 1 year.
• Implanted cardiac devices that prevented achievement of the heart rate required for exercise training.
• Cardiovascular, metabolic, or other clinical contraindications to exercise testing or training.

Sponsors & Collaborators

• Asia University: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 12, 2026
• First Posted: September 23, 2026
• Study Start: August 24, 2022
• Primary Completion: December 28, 2025
• Study Completion: December 28, 2025
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)