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

Primary Purpose

Hemolysis, Exercise, Sleep Disorder

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Cycling exercise
Sponsored by
Buddhist Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemolysis

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Buddhist Tzu Chi General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intradialytic exercise

Control group

Arm Description

Cycling exercise 30 minutes a time, three times a week during hemodialysis

not participate in cycling exercise during hemodialysis

Outcomes

Primary Outcome Measures

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.
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.
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.
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
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.
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
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 15, 2019
Last Updated
March 1, 2022
Sponsor
Buddhist Tzu Chi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04098848
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Buddhist Tzu Chi General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemolysis, Exercise, Sleep Disorder, Fatigue, Adipocytes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intradialytic exercise
Arm Type
Experimental
Arm Description
Cycling exercise 30 minutes a time, three times a week during hemodialysis
Arm Title
Control group
Arm Type
No Intervention
Arm Description
not participate in cycling exercise during hemodialysis
Intervention Type
Other
Intervention Name(s)
Cycling exercise
Intervention Description
Intradialytic cycling exercise for 30 minutes a time
Primary Outcome Measure Information:
Title
Change of the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-F) score for 2 years
Description
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.
Time Frame
pre-test and then every 3 months for 2 years
Title
Change of the Pittsburgh Sleep Quality Index (PSQI) score for 2 years
Description
Compare the PSQI score before, during and after intradialytic cycling exercise PSQI score is from 0-21 points; score>=5 means poor sleeping quality.
Time Frame
pre-test and then every 3 months for 2 years
Title
Change of the carotid-femoral pulse wave velocity (cfPWV) for 2 years
Description
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.
Time Frame
pre-test and then every 3 months for 2 years
Title
Change of the cardio-ankle vascular index (CAVI) for 2 years
Description
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
Time Frame
pre-test and then every 3 months for 2 years
Title
Change of the brachial-ankle pulse wave velocity (baPWV) for 2 years
Description
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.
Time Frame
pre-test and then every 3 months for 2 years
Title
Change of the aortic augmentation index(AI) measurements for 2 years
Description
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
Time Frame
pre-test and then every 3 months for 2 years
Title
Change of the brachial flow-mediated vasodilatation (bFMD) for 2 years
Description
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.
Time Frame
pre-test and then every 3 months for 2 years
Title
Change of the digital thermal monitoring (DTM) for 2 years
Description
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.
Time Frame
pre-test and then every 3 months for 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Hsien Lai
Organizational Affiliation
Attending physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Buddhist Tzu Chi General Hospital
City
Hualien City
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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