Intradialytic Exercise on the Fatigue, Sleep Disorder, Arterial Stiffness and Endothelial Function in Uremic Patients

NCT ID: NCT04098848

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2021-12-31

Brief Summary

To determine the effect of intradialytic cycling exercise on fatigability, sleep disorders, arterial stiffness and endothelial function in dialysis patients

Detailed Description

The endothelium is a key regulator of vascular homeostasis and chronic exposure to vascular risk factors alters the regulatory properties of the endothelium, which progresses toward a pro-inflammatory pattern, senescence, and apoptosis. Endothelial cell integrity and function are critical to the prevention of atherosclerosis, and therefore endothelial cell injury and dysfunction are major steps in the development and progression of cardiovascular disease. Endothelial dysfunction may be the landmark of active disease process through the course of atherosclerotic cardiovascular disease, and a significant risk factor for future cardiovascular events.

Several studies had reported that not only medical treatment but also exercise could improve physical and vascular functions, dialytic efficiency, quality of sleep, fatigue and depression et al. Exercise could be classified to aerobic, Anaerobic exercise and resistance et. Several studies have shown that regular cycling exercise in hemodialysis patients could improve physical activity, sleep quality, and reduce fatigability. Therefore, exercise plays an important role in hemodialysis patients. According to these benefits, the investigator's study was designed to explore the effects of intradialytic cycling exercise on sleep quality and fatigability, adipokines and myokinins levels in hemodialysis patients.

Conditions

Hemolysis; Exercise; Sleep Disorder; Fatigue; Adipocytes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intradialytic exercise

Cycling exercise 30 minutes a time, three times a week during hemodialysis

Group Type: EXPERIMENTAL

Cycling exercise

Intervention Type: OTHER

Intradialytic cycling exercise for 30 minutes a time

Control group

not participate in cycling exercise during hemodialysis

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cycling exercise

Intradialytic cycling exercise for 30 minutes a time

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Regular hemodialysis more than 3 months with 4 hours a time, thrice a week
• Eligible to sign permit

Exclusion Criteria

• Could not sign permit or do not want to join the trial
• Infection
• Amputation of any one of the lower limb
• Hemodynamic unstable
• Acute myocardial infarction (AMI) in recent 6 months
• Unstable heart condition, such as unstable angina, arrythmia
• Deep vein thrombosis (DVT)
• History of kidney transplantation
• Vascular access over lower limb

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Buddhist Tzu Chi General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Hsien Lai

Role: PRINCIPAL_INVESTIGATOR

Attending physician

Locations

Buddhist Tzu Chi General Hospital

Hualien City, , Taiwan

Countries

Taiwan

Other Identifiers

IRB106-139-A

Identifier Type: -

Identifier Source: org_study_id