The Effects of HRV Biofeedback on Chronic Kidney Disease Patient.

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

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).

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases; Inflammatory Response; Autonomic Dysfunction
• Intervention / Treatment: Behavioral: heart rate variability biofeedback

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu-Ju CHEN, Ph.D; Phone Number: 18762 886-2-87923100; Email: judychen37@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Tri-Service Medical Center
    • Contact: Yu-Ju Chen, Ph.D.; Phone Number: 18762 886-2-87923100; Email: judychen37@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; routine care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
autonomic nerve function	heart rate variability index	baseline
autonomic nerve function	heart rate variability index	1 month
autonomic nerve function	heart rate variability index	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inflammatory response 1	C reaction protein, CRP(ng/ml)	baseline
inflammatory response 2	Interleukin-6, IL-6(pg/ml)	baseline
inflammatory response 1	C reaction protein, CRP(ng/ml)	1 month
inflammatory response 2	Interleukin-6, IL-6(pg/ml)	1 month
inflammatory response 1	C reaction protein, CRP(ng/ml)	3 month
inflammatory response 2	Interleukin-6, IL-6(pg/ml)	3 month
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.	baseline
symptom distress(sleep)	Pittsburgh Sleep Quality Index	baseline
symptom distress(depression)	Beck Depression Inventory-II	baseline
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.	1 month
symptom distress(sleep)	Pittsburgh Sleep Quality Index	1 month
symptom distress(depression)	Beck Depression Inventory-II	1 month
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.	3 month
symptom distress(sleep)	Pittsburgh Sleep Quality Index	3 month
symptom distress(depression)	Beck Depression Inventory-II	3 month

Collaborators and Investigators

• Sponsor: National Defense Medical Center, Taiwan
• Investigators: Principal Investigator: YU-CHAN LIN, master, Tri-Service Medical Center Nurse; Principal Investigator: CHIA-PEI Chen, graduate student

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2020
• Primary Completion (Anticipated): November 18, 2023
• Study Completion (Anticipated): December 18, 2023

Study Registration Dates

• First Submitted: September 26, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Primary Dysautonomias; Autonomic Nervous System Diseases
• Other Study ID Numbers: 1-2020-9-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No