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

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

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

Study Overview

• Status: Completed
• Conditions: Fatigue; Sleep Disorder; Exercise; Hemolysis; Adipocytes
• Intervention / Treatment: Other: Cycling exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Hualien City, Taiwan
    • Buddhist Tzu Chi General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intradialytic exercise; Cycling exercise 30 minutes a time, three times a week during hemodialysis	Other: Cycling exercise; Intradialytic cycling exercise for 30 minutes a time
NO_INTERVENTION: Control group; not participate in cycling exercise during hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Buddhist Tzu Chi General Hospital
• Investigators: Principal Investigator: Yu-Hsien Lai, Attending Physician

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: September 15, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (ACTUAL): September 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Fatigue; Sleep Wake Disorders; Parasomnias; Hemolysis
• Other Study ID Numbers: IRB106-139-A

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