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Effects of Biofeedback in Patients With Acute Cerebral Infarction

Primary Purpose

Acute Ischemic Stroke, Biofeedback, Autonomic Dysfunction, Cognitive Function

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
heart rate variability biofeedback
Sponsored by
National Defense Medical Center, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Ischemic Stroke

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients within one week of their first ever ischemic stroke, who were 20 years of age or older, and who were able to express themselves through oral or written communication.

Exclusion Criteria:

  • Patients diagnosed with cardiac arrhythmia, mental illness, dementia or Alzheimer's disease, or totally paralyzed and totally dependent on others for care

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    HRVBF

    Control

    Arm Description

    Heart rate variability biofeedback

    Usual Care

    Outcomes

    Primary Outcome Measures

    Changes From Baseline Psychological Distress (Anxiety and Depression) at 1 and 3 Months
    The hospital anxiety and depression scale was a 14-item ordinal scale, used for participants to self-rate their psychological distress related to anxiety (7 items) and depression (7 items). Items are scored 0(no distress) to 3 (serious distress). Based on the findings from previous studies, scoring at or higher than the cut-off point of 8 out of 21, identified those with anxiety or depression. The minimum and maximum values of both anxiety and depression are 0 and 21, respectively. The higher scores mean a worse outcome.
    Changes From Baseline Cognitive Function at 1 and 3 Months
    The Mini-Mental State Examination (MMSE) was used to measure patients' cognitive function. MMSE includes eleven items and consists of five facets orientation (space and time, registration, attention and calculation, recall, and language). The minimum value is 0 and the maximum value is 30. Lower scores represent a worse cognitive function.
    Changes From Baseline Capabilities of Activities of Daily Living at 1 and 3 Months
    The 10-item Barthel Index (BI) was used to measure participants' capabilities in activities of daily living (ADLs) (feeding, bathing, grooming, dressing, transfers, and toilet use). BI score ranges from 0 to 100 with lower scores indicating lower ADLs capabilities.
    Changes From Baseline Autonomic Function (Time-domain of Heart Rate Variability) at 1 and 3 Months
    Heart rate variability (HRV) was used to represent the autonomic function and measured with Mind Media B.V. (-Nexus-10, Netherlands). Time-domain of HRV was analyzed using Kubios HRV software (Biosignal Analysis and Medical Imaging Group, Finland). Time-domain indices of HRV indices: standard deviation of normal to normal R-R intervals (SDNN) and root mean square of successive heartbeat interval differences (rMSSD), which were reported with the Unit of Measure "ms". The higher scores mean a better outcome.
    Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months
    Heart rate variability (HRV) was used to represent the autonomic function and measured with Mind Media B.V. (-Nexus-10, Netherlands). Frequency-domain of HRV was analyzed using Kubios HRV software (Biosignal Analysis and Medical Imaging Group, Finland). Frequency domain indices of HRV were low frequency (LF), high frequency (HF), and total power (TP), which were reported with the unit of Measure "ms^2". The higher scores mean a better outcome.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 23, 2018
    Last Updated
    September 21, 2019
    Sponsor
    National Defense Medical Center, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03516227
    Brief Title
    Effects of Biofeedback in Patients With Acute Cerebral Infarction
    Official Title
    Effects of Biofeedback Combined With Abdominal Breathing on Physiological and Psychological Aspects in Patients With Acute Cerebral Infarction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 9, 2015 (Actual)
    Primary Completion Date
    June 26, 2016 (Actual)
    Study Completion Date
    August 3, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Defense Medical Center, Taiwan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The major aim of this study is to investigate the effects of biofeedback assisted abdominal breathing training on improving the psychological and physiological distress in patients with ACI. In this randomized, controlled, single-blind trial, AIS patients were randomly assigned into experimental and control groups. The experimental group received four HRVBF training sessions. The control group received routine care. Repeated measures of HRV, Mini-Mental Status Examination (MMSE), Hospital Anxiety and Depression Scales (HADS), and Barthel Index for ADLs were collected prior to, and at one, and three months post-intervention.
    Detailed Description
    Study protocol Participants who provided signed consent were randomly assigned to HRVBF intervention or control group. They underwent baseline measurements of demographics, psychological distress, cognitive impairment, ADL capabilities, and autonomic function. Random numbers from the Bernoulli distribution were calculated using the Excel BINOMDIST function, and concealed in an opaque envelope, until participants' baseline measurements were completed. The HRVBF group received four, one-on-one bedside biofeedback training sessions (20-minutes a day for 4 days), and practiced on their own (10-minutes twice a day) using a FDA-regulated, hand-held mobile biofeedback device (StressEraser, Helico Inc., New York, NY, USA).26 The control group received usual care. Afterwards, all participants were telephoned bi-weekly and encouraged to practice slow breathing (HRVBF group) or to perform self-care (control group) for three months. psychological distress, cognitive impairment, ADL capabilities, and autonomic function (represented by HRV) were re-assessed at one, and 3-months after the intervention, by an independent investigator blinded to group assignment. HRVBF intervention protocol The HRVBF protocol was modified from Lehrer's HRV biofeedback manual.20 A noninvasive visual biofeedback system (NeXus-10 with BioTrace+, Mind Media B.V., Netherlands) and a laptop computer were used for the intervention. Participants in the HRVBF group received four, one-on-one bedside training sessions (20-minutes a day for 4 days). The first session (Day 1) was focused on teaching patients to breath slowly (6-8 breaths-per-minute) and to extend their expiratory phase using pursed-lip breathing. Also, respiration sensors for tracking breathing pace were introduced. The second session (day 2) was focused on teaching patients diaphragmatic breathing in conjunction with pursed-lip breathing, and to use respiratory sensors to pace breathing (6 breaths a minute). The third and fourth sessions (days 3 and 4) were focused on reviewing diaphragmatic breathing, pursed-lip breathing, and teaching patients to breathe in-phase with their heart rate changes. Additionally, participants were encouraged to practice slow diaphragmatic and pursed-lip breathing, on their own, with the aid of the hand-held biofeedback device, for 10 minutes, twice-a-day, during the 4-day training period.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Ischemic Stroke, Biofeedback, Autonomic Dysfunction, Cognitive Function, Psychological Distress

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HRVBF
    Arm Type
    Experimental
    Arm Description
    Heart rate variability biofeedback
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Usual Care
    Intervention Type
    Behavioral
    Intervention Name(s)
    heart rate variability biofeedback
    Intervention Description
    The HRVBF group received four, one-on-one bedside biofeedback training sessions (20-minutes a day for 4 days), and practiced on their own (10-minutes twice a day) using a FDA-regulated, hand-held mobile biofeedback device (StressEraser, Helico Inc., New York, NY, USA).26 The control group received usual care.Afterwards, all participants were telephoned bi-weekly and encouraged to practice slow breathing (HRVBF group) or to perform self-care (control group) for three months.
    Primary Outcome Measure Information:
    Title
    Changes From Baseline Psychological Distress (Anxiety and Depression) at 1 and 3 Months
    Description
    The hospital anxiety and depression scale was a 14-item ordinal scale, used for participants to self-rate their psychological distress related to anxiety (7 items) and depression (7 items). Items are scored 0(no distress) to 3 (serious distress). Based on the findings from previous studies, scoring at or higher than the cut-off point of 8 out of 21, identified those with anxiety or depression. The minimum and maximum values of both anxiety and depression are 0 and 21, respectively. The higher scores mean a worse outcome.
    Time Frame
    baseline, 1-month, and 3-month visits
    Title
    Changes From Baseline Cognitive Function at 1 and 3 Months
    Description
    The Mini-Mental State Examination (MMSE) was used to measure patients' cognitive function. MMSE includes eleven items and consists of five facets orientation (space and time, registration, attention and calculation, recall, and language). The minimum value is 0 and the maximum value is 30. Lower scores represent a worse cognitive function.
    Time Frame
    baseline, 1-month, and 3-month visits
    Title
    Changes From Baseline Capabilities of Activities of Daily Living at 1 and 3 Months
    Description
    The 10-item Barthel Index (BI) was used to measure participants' capabilities in activities of daily living (ADLs) (feeding, bathing, grooming, dressing, transfers, and toilet use). BI score ranges from 0 to 100 with lower scores indicating lower ADLs capabilities.
    Time Frame
    baseline, 1-month, and 3-month visits
    Title
    Changes From Baseline Autonomic Function (Time-domain of Heart Rate Variability) at 1 and 3 Months
    Description
    Heart rate variability (HRV) was used to represent the autonomic function and measured with Mind Media B.V. (-Nexus-10, Netherlands). Time-domain of HRV was analyzed using Kubios HRV software (Biosignal Analysis and Medical Imaging Group, Finland). Time-domain indices of HRV indices: standard deviation of normal to normal R-R intervals (SDNN) and root mean square of successive heartbeat interval differences (rMSSD), which were reported with the Unit of Measure "ms". The higher scores mean a better outcome.
    Time Frame
    baseline, 1-month, and 3-month visits
    Title
    Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months
    Description
    Heart rate variability (HRV) was used to represent the autonomic function and measured with Mind Media B.V. (-Nexus-10, Netherlands). Frequency-domain of HRV was analyzed using Kubios HRV software (Biosignal Analysis and Medical Imaging Group, Finland). Frequency domain indices of HRV were low frequency (LF), high frequency (HF), and total power (TP), which were reported with the unit of Measure "ms^2". The higher scores mean a better outcome.
    Time Frame
    baseline, 1-month, and 3-month visits

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients within one week of their first ever ischemic stroke, who were 20 years of age or older, and who were able to express themselves through oral or written communication. Exclusion Criteria: Patients diagnosed with cardiac arrhythmia, mental illness, dementia or Alzheimer's disease, or totally paralyzed and totally dependent on others for care
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yu-Ju Chen, Ph.D.
    Organizational Affiliation
    National Defense Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects of Biofeedback in Patients With Acute Cerebral Infarction

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