The Effects of HRV Biofeedback on Chronic Kidney Disease Patient.

Not Applicable

Recruiting

• Conditions: Chronic Kidney Diseases; Inflammatory Response; Autonomic Dysfunction
• Interventions: Behavioral: heart rate variability biofeedback

• Registration Number: NCT04611334
• Lead Sponsor: National Defense Medical Center, Taiwan

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.

Study Timeline

• Study Start: 2020-09-17
• Study First Submitted: 2020-09-26
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-11-02
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23
• Primary Completion: 2023-11-18
• Study Completion: 2023-12-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	heart rate variability biofeedback	HRV biofeedback

Primary Outcome Measures

Name	Time	Method
autonomic nerve function	3 month	heart rate variability index

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tri-Service Medical Center; 🇨🇳 Taipei, Taiwan