Acute Ischemic Stroke, Autonomic Dysfunction, Cognitive Function, Biofeedback, Psychological Distress
Conditions
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.
Interventions
BEHAVIORALheart rate variability biofeedback
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.
Sponsors
National Defense Medical Center, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months | baseline, 1-month, and 3-month visits | 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. |
| Changes From Baseline Psychological Distress (Anxiety and Depression) at 1 and 3 Months | baseline, 1-month, and 3-month visits | 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 | baseline, 1-month, and 3-month visits | 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 | baseline, 1-month, and 3-month visits | 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 | baseline, 1-month, and 3-month visits | 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. |
Participant flow
Recruitment details
Participants were recruited from the neurological ward at a medical center in northern Taiwan.
Pre-assignment details
Five patients did not receive the allocated group treatment protocol (two had arrhythmias after inclusion and three refused baseline measurements)
Participants by arm
| Arm | Count |
|---|---|
| HRVBF Heart rate variability biofeedback
heart rate variability biofeedback: 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). 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. | 19 |
| Control Usual Care | 16 |
| Total | 35 |
Baseline characteristics
| Characteristic | HRVBF | Control | Total |
|---|---|---|---|
| Age, Continuous | 67.6 years STANDARD_DEVIATION 11.4 | 67.2 years STANDARD_DEVIATION 7.6 | 67.4 years STANDARD_DEVIATION 9.7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Taiwan | 19 participants | 16 participants | 35 participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 10 Participants | 8 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: baseline, 1-month, and 3-month visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HRVBF | Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months | Baseline_HF ln | 3.27 ms^2 | Standard Deviation 0.55 |
| HRVBF | Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months | 1-month_TP ln | 4.74 ms^2 | Standard Deviation 0.56 |
| HRVBF | Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months | 1-month_LF ln | 4.08 ms^2 | Standard Deviation 0.62 |
| HRVBF | Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months | 3-month_LF ln | 4.01 ms^2 | Standard Deviation 0.76 |
| HRVBF | Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months | Baseline_TP ln | 4.14 ms^2 | Standard Deviation 0.63 |
| HRVBF | Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months | 3-month_HF ln | 3.64 ms^2 | Standard Deviation 0.5 |
| HRVBF | Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months | 1-month_HF ln | 3.73 ms^2 | Standard Deviation 0.56 |
| HRVBF | Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months | 3-month_TP ln | 4.73 ms^2 | Standard Deviation 0.58 |
| HRVBF | Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months | Baseline_LF ln | 3.41 ms^2 | Standard Deviation 0.87 |
| Control | Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months | 3-month_TP ln | 4.59 ms^2 | Standard Deviation 0.45 |
| Control | Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months | Baseline_LF ln | 3.79 ms^2 | Standard Deviation 0.79 |
| Control | Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months | Baseline_HF ln | 3.51 ms^2 | Standard Deviation 0.39 |
| Control | Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months | Baseline_TP ln | 4.44 ms^2 | Standard Deviation 0.56 |
| Control | Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months | 1-month_LF ln | 3.80 ms^2 | Standard Deviation 0.52 |
| Control | Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months | 1-month_HF ln | 3.73 ms^2 | Standard Deviation 0.47 |
| Control | Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months | 1-month_TP ln | 4.58 ms^2 | Standard Deviation 0.4 |
| Control | Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months | 3-month_LF ln | 3.85 ms^2 | Standard Deviation 0.6 |
| Control | Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months | 3-month_HF ln | 3.52 ms^2 | Standard Deviation 0.51 |
Primary
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.
Time frame: baseline, 1-month, and 3-month visits
Population: Thirty-five participants completed all aspects of the study (19 intervention, 16 control)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HRVBF | Changes From Baseline Autonomic Function (Time-domain of Heart Rate Variability) at 1 and 3 Months | Baseline_SDNN ln | 2.24 ms | Standard Deviation 0.26 |
| HRVBF | Changes From Baseline Autonomic Function (Time-domain of Heart Rate Variability) at 1 and 3 Months | Baseline_rMSSD ln | 2.37 ms | Standard Deviation 0.27 |
| HRVBF | Changes From Baseline Autonomic Function (Time-domain of Heart Rate Variability) at 1 and 3 Months | 1-month_SDNN ln | 2.44 ms | Standard Deviation 0.24 |
| HRVBF | Changes From Baseline Autonomic Function (Time-domain of Heart Rate Variability) at 1 and 3 Months | 1-month_rMSSD ln | 2.51 ms | Standard Deviation 0.24 |
| HRVBF | Changes From Baseline Autonomic Function (Time-domain of Heart Rate Variability) at 1 and 3 Months | 3-month_SDNN ln | 2.47 ms | Standard Deviation 0.27 |
| HRVBF | Changes From Baseline Autonomic Function (Time-domain of Heart Rate Variability) at 1 and 3 Months | 3-month_rMSSD ln | 2.56 ms | Standard Deviation 0.24 |
| Control | Changes From Baseline Autonomic Function (Time-domain of Heart Rate Variability) at 1 and 3 Months | 3-month_SDNN ln | 2.43 ms | Standard Deviation 0.19 |
| Control | Changes From Baseline Autonomic Function (Time-domain of Heart Rate Variability) at 1 and 3 Months | Baseline_SDNN ln | 2.38 ms | Standard Deviation 0.18 |
| Control | Changes From Baseline Autonomic Function (Time-domain of Heart Rate Variability) at 1 and 3 Months | 1-month_rMSSD ln | 2.58 ms | Standard Deviation 0.17 |
| Control | Changes From Baseline Autonomic Function (Time-domain of Heart Rate Variability) at 1 and 3 Months | Baseline_rMSSD ln | 2.50 ms | Standard Deviation 0.15 |
| Control | Changes From Baseline Autonomic Function (Time-domain of Heart Rate Variability) at 1 and 3 Months | 3-month_rMSSD ln | 2.52 ms | Standard Deviation 0.19 |
| Control | Changes From Baseline Autonomic Function (Time-domain of Heart Rate Variability) at 1 and 3 Months | 1-month_SDNN ln | 2.46 ms | Standard Deviation 0.14 |
Primary
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.
Time frame: baseline, 1-month, and 3-month visits
Population: Thirty-five participants completed all aspects of the study (19 intervention, 16 control)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HRVBF | Changes From Baseline Capabilities of Activities of Daily Living at 1 and 3 Months | Baseline_BI | 45.00 score on a scale | Standard Deviation 24.27 |
| HRVBF | Changes From Baseline Capabilities of Activities of Daily Living at 1 and 3 Months | 1-month_BI | 54.47 score on a scale | Standard Deviation 23.09 |
| HRVBF | Changes From Baseline Capabilities of Activities of Daily Living at 1 and 3 Months | 3-month_BI | 67.11 score on a scale | Standard Deviation 22.5 |
| Control | Changes From Baseline Capabilities of Activities of Daily Living at 1 and 3 Months | Baseline_BI | 45.31 score on a scale | Standard Deviation 12.31 |
| Control | Changes From Baseline Capabilities of Activities of Daily Living at 1 and 3 Months | 1-month_BI | 54.38 score on a scale | Standard Deviation 14.48 |
| Control | Changes From Baseline Capabilities of Activities of Daily Living at 1 and 3 Months | 3-month_BI | 65.00 score on a scale | Standard Deviation 18.07 |
Primary
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.
Time frame: baseline, 1-month, and 3-month visits
Population: Thirty-five participants completed all aspects of the study (19 intervention, 16 control)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HRVBF | Changes From Baseline Cognitive Function at 1 and 3 Months | Baseline_MMSE | 18.84 score on a scale | Standard Error 3.88 |
| HRVBF | Changes From Baseline Cognitive Function at 1 and 3 Months | 1-month_MMSE | 21.68 score on a scale | Standard Error 4.23 |
| HRVBF | Changes From Baseline Cognitive Function at 1 and 3 Months | 3-month_MMSE | 23.74 score on a scale | Standard Error 3.86 |
| Control | Changes From Baseline Cognitive Function at 1 and 3 Months | Baseline_MMSE | 20.00 score on a scale | Standard Error 3.48 |
| Control | Changes From Baseline Cognitive Function at 1 and 3 Months | 1-month_MMSE | 21.00 score on a scale | Standard Error 3.46 |
| Control | Changes From Baseline Cognitive Function at 1 and 3 Months | 3-month_MMSE | 22.38 score on a scale | Standard Error 3.34 |
Primary
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.
Time frame: baseline, 1-month, and 3-month visits
Population: Thirty-five participants completed all aspects of the study (19 intervention, 16 control)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HRVBF | Changes From Baseline Psychological Distress (Anxiety and Depression) at 1 and 3 Months | Baseline_Anxiety | 14.74 score on a scale | Standard Deviation 4.15 |
| HRVBF | Changes From Baseline Psychological Distress (Anxiety and Depression) at 1 and 3 Months | Baseline_Depression | 13.11 score on a scale | Standard Deviation 3.2 |
| HRVBF | Changes From Baseline Psychological Distress (Anxiety and Depression) at 1 and 3 Months | 1-month_Anxiety | 12.79 score on a scale | Standard Deviation 3.16 |
| HRVBF | Changes From Baseline Psychological Distress (Anxiety and Depression) at 1 and 3 Months | 1-month_Depression | 11.53 score on a scale | Standard Deviation 4.2 |
| HRVBF | Changes From Baseline Psychological Distress (Anxiety and Depression) at 1 and 3 Months | 3-month_Anxiety | 10.58 score on a scale | Standard Deviation 2.97 |
| HRVBF | Changes From Baseline Psychological Distress (Anxiety and Depression) at 1 and 3 Months | 3-month_Depression | 8.42 score on a scale | Standard Deviation 4.99 |
| Control | Changes From Baseline Psychological Distress (Anxiety and Depression) at 1 and 3 Months | 3-month_Anxiety | 12.88 score on a scale | Standard Deviation 3.03 |
| Control | Changes From Baseline Psychological Distress (Anxiety and Depression) at 1 and 3 Months | Baseline_Anxiety | 14.75 score on a scale | Standard Deviation 3.3 |
| Control | Changes From Baseline Psychological Distress (Anxiety and Depression) at 1 and 3 Months | 1-month_Depression | 15.75 score on a scale | Standard Deviation 2.82 |
| Control | Changes From Baseline Psychological Distress (Anxiety and Depression) at 1 and 3 Months | Baseline_Depression | 14.25 score on a scale | Standard Deviation 2.97 |
| Control | Changes From Baseline Psychological Distress (Anxiety and Depression) at 1 and 3 Months | 3-month_Depression | 13.25 score on a scale | Standard Deviation 4.12 |
| Control | Changes From Baseline Psychological Distress (Anxiety and Depression) at 1 and 3 Months | 1-month_Anxiety | 15.38 score on a scale | Standard Deviation 2.09 |