Clinical trial NCT04098848: Intradialytic Exercise on the Fatigue, Sleep Disorder, Arterial Stiffness and Endothelial Function in Uremic Patients
Official title: The Effect of Intradialytic Exercise on the Fatigue, Sleep Disorder, Arterial Stiffness and Endothelial Function in Uremic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemolysis
Exercise
Sleep Disorder
Fatigue
Adipocytes
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 114
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-F) score for 2 years
timeFrame: pre-test and then every 3 months for 2 years
measure: Change of the Pittsburgh Sleep Quality Index (PSQI) score for 2 years
timeFrame: pre-test and then every 3 months for 2 years
measure: Change of the carotid-femoral pulse wave velocity (cfPWV) for 2 years
timeFrame: pre-test and then every 3 months for 2 years
measure: Change of the cardio-ankle vascular index (CAVI) for 2 years
timeFrame: pre-test and then every 3 months for 2 years
measure: Change of the brachial-ankle pulse wave velocity (baPWV) for 2 years
timeFrame: pre-test and then every 3 months for 2 years
measure: Change of the aortic augmentation index(AI) measurements for 2 years
timeFrame: pre-test and then every 3 months for 2 years
measure: Change of the brachial flow-mediated vasodilatation (bFMD) for 2 years
timeFrame: pre-test and then every 3 months for 2 years
measure: Change of the digital thermal monitoring (DTM) for 2 years
timeFrame: pre-test and then every 3 months for 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Buddhist Tzu Chi General Hospital
Study officials:
affiliation: Attending physician
name: Yu-Hsien Lai
role: PRINCIPAL_INVESTIGATOR
References: