The Effects of HRV Biofeedback on Chronic Kidney Disease Patient.
Primary Purpose
Autonomic Dysfunction, Inflammatory Response, Chronic Kidney Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
heart rate variability biofeedback
Sponsored by
About this trial
This is an interventional supportive care trial for Autonomic Dysfunction
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of chronic kidney disease
- Clear consciousness
- able to communicate in Mandarin or Taiwanese
- no urgency in the past three months
- No hospitalization record in the past three months.
Exclusion Criteria:
- arrhythmia
- with pacemaker
- those with visual or hearing impairments that cannot be corrected and hinder communication
- receiving dialysis treatment
- receiving kidneys Transplant recipients
- history of rheumatic immune disease or cancer.
Sites / Locations
- Tri-Service Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
experimental group
control group
Arm Description
HRV biofeedback
routine care
Outcomes
Primary Outcome Measures
autonomic nerve function
heart rate variability index
autonomic nerve function
heart rate variability index
autonomic nerve function
heart rate variability index
Secondary Outcome Measures
inflammatory response 1
C reaction protein, CRP(ng/ml)
inflammatory response 2
Interleukin-6, IL-6(pg/ml)
inflammatory response 1
C reaction protein, CRP(ng/ml)
inflammatory response 2
Interleukin-6, IL-6(pg/ml)
inflammatory response 1
C reaction protein, CRP(ng/ml)
inflammatory response 2
Interleukin-6, IL-6(pg/ml)
symptom distress(fatigue)
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.
symptom distress(sleep)
Pittsburgh Sleep Quality Index
symptom distress(depression)
Beck Depression Inventory-II
symptom distress(fatigue)
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.
symptom distress(sleep)
Pittsburgh Sleep Quality Index
symptom distress(depression)
Beck Depression Inventory-II
symptom distress(fatigue)
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.
symptom distress(sleep)
Pittsburgh Sleep Quality Index
symptom distress(depression)
Beck Depression Inventory-II
Full Information
NCT ID
NCT04611334
First Posted
September 26, 2020
Last Updated
March 21, 2023
Sponsor
National Defense Medical Center, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT04611334
Brief Title
The Effects of HRV Biofeedback on Chronic Kidney Disease Patient.
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 17, 2020 (Actual)
Primary Completion Date
November 18, 2023 (Anticipated)
Study Completion Date
December 18, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Defense Medical Center, Taiwan
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
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autonomic Dysfunction, Inflammatory Response, Chronic Kidney Diseases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
HRV biofeedback
Arm Title
control group
Arm Type
No Intervention
Arm Description
routine care
Intervention Type
Behavioral
Intervention Name(s)
heart rate variability biofeedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
autonomic nerve function
Description
heart rate variability index
Time Frame
baseline
Title
autonomic nerve function
Description
heart rate variability index
Time Frame
1 month
Title
autonomic nerve function
Description
heart rate variability index
Time Frame
3 month
Secondary Outcome Measure Information:
Title
inflammatory response 1
Description
C reaction protein, CRP(ng/ml)
Time Frame
baseline
Title
inflammatory response 2
Description
Interleukin-6, IL-6(pg/ml)
Time Frame
baseline
Title
inflammatory response 1
Description
C reaction protein, CRP(ng/ml)
Time Frame
1 month
Title
inflammatory response 2
Description
Interleukin-6, IL-6(pg/ml)
Time Frame
1 month
Title
inflammatory response 1
Description
C reaction protein, CRP(ng/ml)
Time Frame
3 month
Title
inflammatory response 2
Description
Interleukin-6, IL-6(pg/ml)
Time Frame
3 month
Title
symptom distress(fatigue)
Description
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.
Time Frame
baseline
Title
symptom distress(sleep)
Description
Pittsburgh Sleep Quality Index
Time Frame
baseline
Title
symptom distress(depression)
Description
Beck Depression Inventory-II
Time Frame
baseline
Title
symptom distress(fatigue)
Description
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.
Time Frame
1 month
Title
symptom distress(sleep)
Description
Pittsburgh Sleep Quality Index
Time Frame
1 month
Title
symptom distress(depression)
Description
Beck Depression Inventory-II
Time Frame
1 month
Title
symptom distress(fatigue)
Description
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.
Time Frame
3 month
Title
symptom distress(sleep)
Description
Pittsburgh Sleep Quality Index
Time Frame
3 month
Title
symptom distress(depression)
Description
Beck Depression Inventory-II
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of chronic kidney disease
Clear consciousness
able to communicate in Mandarin or Taiwanese
no urgency in the past three months
No hospitalization record in the past three months.
Exclusion Criteria:
arrhythmia
with pacemaker
those with visual or hearing impairments that cannot be corrected and hinder communication
receiving dialysis treatment
receiving kidneys Transplant recipients
history of rheumatic immune disease or cancer.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Ju CHEN, Ph.D
Phone
886-2-87923100
Ext
18762
Email
judychen37@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YU-CHAN LIN, master
Organizational Affiliation
Tri-Service Medical Center Nurse
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
CHIA-PEI Chen
Organizational Affiliation
Graduate Student
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tri-Service Medical Center
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Ju Chen, Ph.D.
Phone
886-2-87923100
Ext
18762
Email
judychen37@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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