Autonomic DysfunctionNCT04611334
The Effects of HRV Biofeedback on Chronic Kidney Disease Patient.
A study testing heart rate variability biofeedback in people with Autonomic Dysfunction and Inflammatory Response, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Autonomic Dysfunction, Inflammatory Response, Chronic Kidney Diseases
- What is being tested?
- heart rate variability biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Sep 2020to 18 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service Medical Center
Taipei
Yu-Ju Chen, Ph.D., 886-2-87923100 ext. 18762, judychen37@gmail.com
About this study
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
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).
Read the 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.
- Being tested
- heart rate variability biofeedback
- Medical subject headings
- Primary Dysautonomias, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heart rate variability biofeedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | HRV biofeedback Receives: Behavioral: heart rate variability biofeedback |
| control group | No intervention | routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
autonomic nerve function
heart rate variability index
Measured: baseline
autonomic nerve function
heart rate variability index
Measured: 1 month
autonomic nerve function
heart rate variability index
Measured: 3 month
Secondary outcomes (15)
inflammatory response 1
C reaction protein, CRP(ng/ml)
Measured: baseline
inflammatory response 2
Interleukin-6, IL-6(pg/ml)
Measured: baseline
inflammatory response 1
C reaction protein, CRP(ng/ml)
Measured: 1 month
inflammatory response 2
Interleukin-6, IL-6(pg/ml)
Measured: 1 month
inflammatory response 1
C reaction protein, CRP(ng/ml)
Measured: 3 month
inflammatory response 2
Interleukin-6, IL-6(pg/ml)
Measured: 3 month
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.
Measured: baseline
symptom distress(sleep)
Pittsburgh Sleep Quality Index
Measured: baseline
symptom distress(depression)
Beck Depression Inventory-II
Measured: baseline
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.
Measured: 1 month
symptom distress(sleep)
Pittsburgh Sleep Quality Index
Measured: 1 month
symptom distress(depression)
Beck Depression Inventory-II
Measured: 1 month
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.
Measured: 3 month
symptom distress(sleep)
Pittsburgh Sleep Quality Index
Measured: 3 month
symptom distress(depression)
Beck Depression Inventory-II
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start17 Sep 2020
- Primary completion18 Nov 2023 (estimated)
- Study completion18 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Ju Chen, National Defense Medical Center, Taiwan
- Investigators
- YU-CHAN LIN, master, Principal investigator, Tri-Service Medical Center NurseCHIA-PEI Chen, Principal investigator, Graduate Student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611334
- Sponsor's protocol ID
- 1-2020-9-20
- Status last verified
- Mar 2023
- First submitted
- 26 Sep 2020
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04611334
- Acronym / sponsor ID
- 1-2020-9-20
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 18 Nov 2023 (estimated)
- Study completion
- 18 Dec 2023 (estimated)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: heart rate variability biofeedbackHRV biofeedback |
| control group | No intervention | –routine care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- arrhythmia
- with pacemaker
- those with visual or hearing impairments that cannot be corrected and hinder communication
- receiving dialysis treatment
- receiving kidneys Transplant recipients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heart rate variability biofeedbackHeart 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. | Behavioural | experimental group |
Primary outcome
autonomic nerve function
Time frame: baseline
heart rate variability index
autonomic nerve function
Time frame: 1 month
heart rate variability index
autonomic nerve function
Time frame: 3 month
heart rate variability index
15 secondary outcomes
inflammatory response 1
Time frame: baseline
inflammatory response 2
Time frame: baseline
inflammatory response 1
Time frame: 1 month
inflammatory response 2
Time frame: 1 month
inflammatory response 1
Time frame: 3 month
inflammatory response 2
Time frame: 3 month
symptom distress(fatigue)
Time frame: baseline
symptom distress(sleep)
Time frame: baseline
symptom distress(depression)
Time frame: baseline
symptom distress(fatigue)
Time frame: 1 month
symptom distress(sleep)
Time frame: 1 month
symptom distress(depression)
Time frame: 1 month
symptom distress(fatigue)
Time frame: 3 month
symptom distress(sleep)
Time frame: 3 month
symptom distress(depression)
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YU-CHAN LIN, master principal investigator
Tri-Service Medical Center Nurse
CHIA-PEI Chen principal investigator
Graduate Student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heart rate variability biofeedback in people with Autonomic Dysfunction and Inflammatory Response, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Ju CHEN, Ph.D (886-2-87923100 ext. 18762, judychen37@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
autonomic nerve function (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.