Clinical trial NCT04611334: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Autonomic Dysfunction
Inflammatory Response
Chronic Kidney Diseases
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: autonomic nerve function
timeFrame: baseline
measure: autonomic nerve function
timeFrame: 1 month
measure: autonomic nerve function
timeFrame: 3 month
Secondary outcomes:
measure: inflammatory response 1
timeFrame: baseline
measure: inflammatory response 2
timeFrame: baseline
measure: inflammatory response 1
timeFrame: 1 month
measure: inflammatory response 2
timeFrame: 1 month
measure: inflammatory response 1
timeFrame: 3 month
measure: inflammatory response 2
timeFrame: 3 month
measure: symptom distress(fatigue)
timeFrame: baseline
measure: symptom distress(sleep)
timeFrame: baseline
measure: symptom distress(depression)
timeFrame: baseline
measure: symptom distress(fatigue)
timeFrame: 1 month
measure: symptom distress(sleep)
timeFrame: 1 month
measure: symptom distress(depression)
timeFrame: 1 month
measure: symptom distress(fatigue)
timeFrame: 3 month
measure: symptom distress(sleep)
timeFrame: 3 month
measure: symptom distress(depression)
timeFrame: 3 month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service Medical Center
Study officials:
affiliation: Tri-Service Medical Center Nurse
name: YU-CHAN LIN, master
role: PRINCIPAL_INVESTIGATOR
affiliation: Graduate Student
name: CHIA-PEI Chen
role: PRINCIPAL_INVESTIGATOR
References: