Intradialytic Exercise on the Fatigue, Sleep Disorder, Arterial Stiffness and Endothelial Function in Uremic Patients
- Conditions
- Sleep DisorderHemolysisAdipocytesExerciseFatigue
- Interventions
- Other: Cycling exercise
- Registration Number
- NCT04098848
- Lead Sponsor
- Buddhist Tzu Chi General Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- Regular hemodialysis more than 3 months with 4 hours a time, thrice a week
- Eligible to sign permit
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intradialytic exercise Cycling exercise Cycling exercise 30 minutes a time, three times a week during hemodialysis
- Primary Outcome Measures
Name Time Method Change of the cardio-ankle vascular index (CAVI) for 2 years pre-test and then every 3 months 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 ≥ 9Change of the digital thermal monitoring (DTM) for 2 years pre-test and then every 3 months 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.Change of the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-F) score for 2 years pre-test and then every 3 months 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.
Change of the Pittsburgh Sleep Quality Index (PSQI) score for 2 years pre-test and then every 3 months 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.
Change of the brachial-ankle pulse wave velocity (baPWV) for 2 years pre-test and then every 3 months 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.Change of the carotid-femoral pulse wave velocity (cfPWV) for 2 years pre-test and then every 3 months 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.Change of the aortic augmentation index(AI) measurements for 2 years pre-test and then every 3 months 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 reflectionChange of the brachial flow-mediated vasodilatation (bFMD) for 2 years pre-test and then every 3 months 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Buddhist Tzu Chi General Hospital
🇨🇳Hualien City, Taiwan