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

NCT04098848 | Completed

• 1 other identifier: IRB106-139-A
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemolysis; Exercise; Sleep Disorder; Fatigue; Adipocytes

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Intradialytic exercise

EXPERIMENTAL

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

Other: Cycling exercise

Control group

NO INTERVENTION

not participate in cycling exercise during hemodialysis

Interventions

Cycling exercise OTHER

Intradialytic cycling exercise for 30 minutes a time

Intradialytic exercise

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Regular hemodialysis more than 3 months with 4 hours a time, thrice a week
• Eligible to sign permit

You may not qualify if:

• 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

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Buddhist Tzu Chi General Hospital

Hualien City, Taiwan

Location

MeSH Terms

Conditions

Hemolysis; Motor Activity; Sleep Wake Disorders; Fatigue

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Study Officials

• Yu-Hsien Lai

  Attending physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2019
• First Posted: September 23, 2019
• Study Start: January 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)