The Effects of HRV Biofeedback on Chronic Kidney Disease Patient.

Chronic Kidney Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04611334
• Other study ID #: 1-2020-9-20
• Status: Recruiting
• Phase: N/A
• Start date: September 17, 2020
• Est. completion date: December 18, 2023

Study information

• Verified date: March 2023
• Source: National Defense Medical Center, Taiwan
• Contact: Yu-Ju CHEN, Ph.D
• Phone: 886-2-87923100
• Email: judychen37[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 18, 2023
• Est. primary completion date: November 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• Chronic Kidney Diseases
• Inflammatory Response
• Kidney Diseases
• Primary Dysautonomias
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Tri-Service Medical Center	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Defense Medical Center, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	autonomic nerve function	heart rate variability index	baseline
Primary	autonomic nerve function	heart rate variability index	1 month
Primary	autonomic nerve function	heart rate variability index	3 month
Secondary	inflammatory response 1	C reaction protein, CRP(ng/ml)	baseline
Secondary	inflammatory response 2	Interleukin-6, IL-6(pg/ml)	baseline
Secondary	inflammatory response 1	C reaction protein, CRP(ng/ml)	1 month
Secondary	inflammatory response 2	Interleukin-6, IL-6(pg/ml)	1 month
Secondary	inflammatory response 1	C reaction protein, CRP(ng/ml)	3 month
Secondary	inflammatory response 2	Interleukin-6, IL-6(pg/ml)	3 month
Secondary	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
Secondary	symptom distress(sleep)	Pittsburgh Sleep Quality Index	baseline
Secondary	symptom distress(depression)	Beck Depression Inventory-II	baseline
Secondary	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
Secondary	symptom distress(sleep)	Pittsburgh Sleep Quality Index	1 month
Secondary	symptom distress(depression)	Beck Depression Inventory-II	1 month
Secondary	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
Secondary	symptom distress(sleep)	Pittsburgh Sleep Quality Index	3 month
Secondary	symptom distress(depression)	Beck Depression Inventory-II	3 month