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NCT Number: NCT04098848

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

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Key information

Conditions

Hemolysis Adipocytes Behavior Exercise Fatigue Mental Disorders Motor Activity Nervous System Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder Sleep Wake Disorders

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Buddhist Tzu Chi General Hospital

Hualien City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cycling exercise

Other

Intradialytic cycling exercise for 30 minutes a time

Primary outcomes

  1. Change of the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-F) score for 2 years

    Time frame: 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.

  2. Change of the Pittsburgh Sleep Quality Index (PSQI) score for 2 years

    Time frame: 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.

  3. Change of the carotid-femoral pulse wave velocity (cfPWV) for 2 years

    Time frame: 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.

  4. Change of the cardio-ankle vascular index (CAVI) for 2 years

    Time frame: 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 ≥ 9

  5. Change of the brachial-ankle pulse wave velocity (baPWV) for 2 years

    Time frame: 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.

  6. Change of the aortic augmentation index(AI) measurements for 2 years

    Time frame: 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 reflection

  7. Change of the brachial flow-mediated vasodilatation (bFMD) for 2 years

    Time frame: 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.

  8. Change of the digital thermal monitoring (DTM) for 2 years

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Buddhist Tzu Chi General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Sep 23, 2019
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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