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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04098848
• Other study ID #: IRB106-139-A
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Buddhist Tzu Chi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adipocytes
• Exercise
• Fatigue
• Hemolysis
• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Other:
• Cycling exercise
Intradialytic cycling exercise for 30 minutes a time

Locations

Country	Name	City	State
Taiwan	Buddhist Tzu Chi General Hospital	Hualien City

Sponsors (1)

Lead Sponsor	Collaborator
Buddhist Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-F) score for 2 years	Compare the FACIT-F score before, during and after intradialytic cycling exercise FACIT-F score is from 0-52 points; higher score represents less fatigue.	pre-test and then every 3 months for 2 years
Primary	Change of the Pittsburgh Sleep Quality Index (PSQI) score for 2 years	Compare the PSQI score before, during and after intradialytic cycling exercise PSQI score is from 0-21 points; score>=5 means poor sleeping quality.	pre-test and then every 3 months for 2 years
Primary	Change of the carotid-femoral pulse wave velocity (cfPWV) for 2 years	Compare the cfPWV before, during and after intradialytic cycling exercise; cfPWV measurement: a measure of aortic wall stiffness, increases markedly with age. Each set of pulse wave and ECG data to calculate the mean time difference between R-wave and pulse wave on a beat-to-beat basis, with an average of 10 consecutive cardiac cycles. The cfPWV will be calculated using the distance and mean time difference between the two recorded points.; Patients with cfPWV values of > 10 m/s were classified in the high arterial stiffness group, whereas those with cfPWV values of =10 m/s were assigned to the low arterial stiffness group.	pre-test and then every 3 months for 2 years
Primary	Change of the cardio-ankle vascular index (CAVI) for 2 years	Compare the CAVI before, during and after intradialytic cycling exercise; CAVI is a novel and accurate method, independent of the effect of blood pressure, and is used as a predictor of arterial stiffness (AS) AS was defined as a CAVI = 9	pre-test and then every 3 months for 2 years
Primary	Change of the brachial-ankle pulse wave velocity (baPWV) for 2 years	Compare the baPWV before, during and after intradialytic cycling exercise; baPWV is one measure arterial stiffness using brachial to ankle arterial wave analyses and has been used to assess peripheral arterial stiffness (PAS); baPWV value >14.0 m/s on either side was considered high PAS.	pre-test and then every 3 months for 2 years
Primary	Change of the aortic augmentation index(AI) measurements for 2 years	Compare the AI before, during and after intradialytic cycling exercise; AI of central blood pressure have been widely used as clinical indices of arterial stiffness AI is an indirect measure of central arterial stiffness, but mainly a direct measure of central wave reflection	pre-test and then every 3 months for 2 years
Primary	Change of the brachial flow-mediated vasodilatation (bFMD) for 2 years	Compare the bFMD before, during and after intradialytic cycling exercise; Endothelial function is often quantified by FMD, which represents the endothelium-dependent relaxation of a conduit artery-typically the brachial artery - due to an increased blood flow.	pre-test and then every 3 months for 2 years
Primary	Change of the digital thermal monitoring (DTM) for 2 years	Compare the DTM before, during and after intradialytic cycling exercise; DTM is a simple noninvasive method to measure endothelial function and vascular reactivity that is correlated with atherosclerosis risk factors and coronary artery disease; Vascular reactivity index (VRI) < 1.0: the poor vascular reactivity, 1.0 = VRI < 2.0: the intermediate vascular reactivity, and VRI = 2.0: the good vascular reactivity.	pre-test and then every 3 months for 2 years