The Effects of HRV Biofeedback on Chronic Kidney Disease Patient.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-17

Study Completion Date

2023-12-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Heart Rate Variability Biofeedback in Older Adults

NCT05902286

Older Adult

COMPLETED EARLY_PHASE1

HRV as a Marker of Treatment Response in PAH Arterial Hypertension

NCT04451850

Pulmonary Arterial Hypertension

COMPLETED

Diaphragmatic Breathing and Heart Rate Variability Training for Improving Hypertension in Fragile X Associated Tremor/Ataxia

NCT03816540

Hypertension FXTAS

COMPLETED PHASE3

HRV and Coaching Preparation Phase Study

NCT05150574

Health Behavior Work Related Stress Job Stress +1 more

COMPLETED PHASE1

Smartphone-Based Use of Phonocardiography Technique for Estimating Heart Rate and Heart Rate Variability: Performance Study

NCT06848179

Exercise

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autonomic Dysfunction Inflammatory Response Chronic Kidney Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

experimental group

HRV biofeedback

Group Type EXPERIMENTAL

heart rate variability biofeedback

Intervention Type 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.

control group

routine care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No