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The Effects of HRV Biofeedback on Chronic Kidney Disease Patient.

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ClinicalTrials.gov Identifier: NCT04611334
Recruitment Status : Recruiting
First Posted : November 2, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Yu-Ju Chen, National Defense Medical Center, Taiwan

Study Description
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Brief Summary:
The prevalence and incidence of end-stage renal disease in Taiwan ranks highest in the world, and it is based on the 2018 health welfare According to statistics from the Ministry of Foreign Affairs, kidney disease is the ninth leading cause of death in Taiwan. As the course of chronic kidney disease (CKD) progresses, autonomic nervous system dysfunction, inflammation, and physical and psychological symptoms (such as fatigue, sleep disturbance, and depression) will increase, which will further damage the structure and function of the kidney Intensified, increasing the demand for dialysis treatment and the risk of cardiovascular disease, which consumes social and medical costs. If the investigators can intervene in a feasible measure to effectively regulate the autonomic nervous function of CKD patients, reduce inflammation and physical and psychological symptoms, and delay the progression of the disease, it will be the main goal of caring for CKD patients. To explore the intervention of heart rate variability biofeedback, which can improve the autonomic nervous function (heart rate variability [Heart Rate Variability]), inflammatory response (interleukin-6 [Interleukin-6, IL-6], C-reactive protein [ C reaction protein, CRP]) and physical and psychological symptoms (such as reducing fatigue, sleep disturbance and depression).

Condition or disease Intervention/treatment Phase
Autonomic Dysfunction Inflammatory Response Chronic Kidney Diseases Behavioral: heart rate variability biofeedback Not Applicable

Detailed Description:
This study adopts an experimental research design and convenient sampling method. It is accepted in the nephrology clinic of a northern medical center in Taiwan. It is estimated that 80 patients will be enrolled. After the patients have signed the consent form, use the sealed envelope website (http://www.sealedenvelope.com) will randomly assigned to the experimental group and the control group. The experimental group receive HRV biofeedback for four consecutive weeks, combined with eight-week StressEraser home practice; the control group received general routine care. Both groups of cases were repeated three times on the day of acceptance, one month and three months after the case were accepted, a total of three repeated measurements of physiological indicators (HRV, IL-6, CRP) and symptom scales (Piper Fatigue Scale, Chinese version of Pittsburgh Sleep Quality Table, the second edition of the Chinese version of the Baker Depression Scale) to evaluate the effectiveness of HRV biofeedback. The research results will be statistically analyzed with SPSS version 23.0, and with descriptive statistics, the distribution of basic demographic data and the measurement results of various indicators will be analyzed. Paired-sample t-test, independent-sample t-test, and multivariate analysis of variance (MANOVA) were used to analyze the statistical results of intervention effectiveness inference; the significance level was set to 0.05.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Heart Rate Variability Biofeedback to Improve Automatic Nervous Function, Inflammatory Response, Physiological and Psychological Symptom Distress in Patients With Chronic Kidney Disease：A Randomized Control Trial
Actual Study Start Date : September 17, 2020
Estimated Primary Completion Date : June 18, 2021
Estimated Study Completion Date : June 18, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: experimental group
HRV biofeedback
 Behavioral: heart rate variability biofeedback
Heart rate variability biological feedback training is carried out in the outpatient meeting room of the hospital, including once a week, 30 minutes of hospital training each time, using Medea physiological feedback device portable Bluetooth physiological signal Feedback system (Medical Device Input No. 027390). Designed as two stages, stage one (the first week) first teaches the subject how to perform abdominal breathing, and connects the physiological feedback device to monitor the patient's breathing and heart rate changes, and sets the breath per minute according to the subject's resonance frequency . Stage two (second-four weeks) guide the case to understand the resonance relationship between breathing and heart rate, and then achieve the effect of matching heart and breath. It is also equipped with a pressure relief device (Helico Inc., New York, NY, USA) for self-practice at home.
No Intervention: control group
routine care


Outcome Measures
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Primary Outcome Measures :
  1. autonomic nerve function [ Time Frame: baseline ]
    heart rate variability index

  2. autonomic nerve function [ Time Frame: 1 month ]
    heart rate variability index

  3. autonomic nerve function [ Time Frame: 3 month ]
    heart rate variability index


Secondary Outcome Measures :
  1. inflammatory response 1 [ Time Frame: baseline ]
    C reaction protein, CRP(ng/ml)

  2. inflammatory response 2 [ Time Frame: baseline ]
    Interleukin-6, IL-6(pg/ml)

  3. inflammatory response 1 [ Time Frame: 1 month ]
    C reaction protein, CRP(ng/ml)

  4. inflammatory response 2 [ Time Frame: 1 month ]
    Interleukin-6, IL-6(pg/ml)

  5. inflammatory response 1 [ Time Frame: 3 month ]
    C reaction protein, CRP(ng/ml)

  6. inflammatory response 2 [ Time Frame: 3 month ]
    Interleukin-6, IL-6(pg/ml)

  7. symptom distress(fatigue) [ Time Frame: baseline ]
    Piper fatigue scale(Chinese version): Likert's four-point quantitative scale is scored, calculated on a scale of 0-3, with a total score of 0-48. The higher the score, the more serious the fatigue.

  8. symptom distress(sleep) [ Time Frame: baseline ]
    Pittsburgh Sleep Quality Index

  9. symptom distress(depression) [ Time Frame: baseline ]
    Beck Depression Inventory-II

  10. symptom distress(fatigue) [ Time Frame: 1 month ]
    Piper fatigue scale(Chinese version): Likert's four-point quantitative scale is scored, calculated on a scale of 0-3, with a total score of 0-48. The higher the score, the more serious the fatigue.

  11. symptom distress(sleep) [ Time Frame: 1 month ]
    Pittsburgh Sleep Quality Index

  12. symptom distress(depression) [ Time Frame: 1 month ]
    Beck Depression Inventory-II

  13. symptom distress(fatigue) [ Time Frame: 3 month ]
    Piper fatigue scale(Chinese version): Likert's four-point quantitative scale is scored, calculated on a scale of 0-3, with a total score of 0-48. The higher the score, the more serious the fatigue.

  14. symptom distress(sleep) [ Time Frame: 3 month ]
    Pittsburgh Sleep Quality Index

  15. symptom distress(depression) [ Time Frame: 3 month ]
    Beck Depression Inventory-II


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of chronic kidney disease
  2. Clear consciousness
  3. able to communicate in Mandarin or Taiwanese
  4. no urgency in the past three months
  5. No hospitalization record in the past three months.

Exclusion Criteria:

  1. arrhythmia
  2. with pacemaker
  3. those with visual or hearing impairments that cannot be corrected and hinder communication
  4. receiving dialysis treatment
  5. receiving kidneys Transplant recipients
  6. history of rheumatic immune disease or cancer.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04611334


Contacts
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Contact: Yu-Ju CHEN, Ph.D 886-2-87923100 ext 18762 judychen37@gmail.com

Locations
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Taiwan
Tri-Service Medical Center Recruiting
Taipei, Taiwan
Contact: Yu-Ju Chen, Ph.D.    886-2-87923100 ext 18762    judychen37@gmail.com   
Sponsors and Collaborators
National Defense Medical Center, Taiwan
Investigators
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Principal Investigator: YU-CHAN LIN, master Tri-Service Medical Center Nurse
Principal Investigator: CHIA-PEI Chen Graduate Student
More Information
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Responsible Party: Yu-Ju Chen, Dean of nursing, National Defense Medical Center, Taiwan
ClinicalTrials.gov Identifier: NCT04611334    
Other Study ID Numbers: 1-2020-9-20
First Posted: November 2, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autonomic Nervous System Diseases
Primary Dysautonomias
Kidney Diseases
Renal Insufficiency, Chronic
 Urologic Diseases
Renal Insufficiency
Nervous System Diseases