The Effects of HRV Biofeedback on Chronic Kidney Disease Patient.

NCT04611334 | Unknown

• 1 other identifier: 1-2020-9-20
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Autonomic Dysfunction; Inflammatory Response; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (15)

• inflammatory response 1

  baseline

• inflammatory response 2

  baseline

• inflammatory response 1

  1 month

• inflammatory response 2

  1 month

• inflammatory response 1

  3 month

Study Arms (2)

experimental group

EXPERIMENTAL

HRV biofeedback

Behavioral: heart rate variability biofeedback

control group

NO INTERVENTION

routine care

Interventions

heart rate variability biofeedback BEHAVIORAL

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.

experimental group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead

Study Sites (1)

Tri-Service Medical Center

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Primary Dysautonomias; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• YU-CHAN LIN, master

  Tri-Service Medical Center Nurse

  PRINCIPAL INVESTIGATOR

• CHIA-PEI Chen

  Graduate Student

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Ju CHEN, Ph.D

CONTACT

886-2-87923100; [email protected]

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of nursing

Study Record Dates

• First Submitted: September 26, 2020
• First Posted: November 2, 2020
• Study Start: September 17, 2020
• Primary Completion: November 18, 2023
• Study Completion: December 18, 2023
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)