Trial Outcomes & Findings for Effects of Biofeedback in Patients With Acute Cerebral Infarction (NCT NCT03516227)

NCT ID: NCT03516227

Last Updated: 2019-10-11

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: baseline, 1-month, and 3-month visits
• Results posted on: 2019-10-11

Participant Flow

Participants were recruited from the neurological ward at a medical center in northern Taiwan.

Five patients did not receive the allocated group treatment protocol (two had arrhythmias after inclusion and three refused baseline measurements)

Participant milestones

Measure	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).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.	Control Usual Care
Overall Study STARTED	20	20
Overall Study COMPLETED	19	16
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	HRVBF n=19 Participants 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.	Control n=16 Participants Usual Care	Total n=35 Participants Total of all reporting groups
Age, Continuous	67.6 years STANDARD_DEVIATION 11.4 • n=19 Participants	67.2 years STANDARD_DEVIATION 7.6 • n=16 Participants	67.4 years STANDARD_DEVIATION 9.7 • n=35 Participants
Sex: Female, Male Female	9 Participants n=19 Participants	8 Participants n=16 Participants	17 Participants n=35 Participants
Sex: Female, Male Male	10 Participants n=19 Participants	8 Participants n=16 Participants	18 Participants n=35 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Taiwan	19 participants n=19 Participants	16 participants n=16 Participants	35 participants n=35 Participants

PRIMARY outcome

Timeframe: baseline, 1-month, and 3-month visits

Population: Thirty-five participants completed all aspects of the study (19 intervention, 16 control)

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.

Outcome measures

Measure	HRVBF n=19 Participants 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).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.	Control n=16 Participants Usual Care
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	14.75 score on a scale Standard Deviation 3.30
Changes From Baseline Psychological Distress (Anxiety and Depression) at 1 and 3 Months Baseline_Depression	13.11 score on a scale Standard Deviation 3.20	14.25 score on a scale Standard Deviation 2.97
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	15.38 score on a scale Standard Deviation 2.09
Changes From Baseline Psychological Distress (Anxiety and Depression) at 1 and 3 Months 1-month_Depression	11.53 score on a scale Standard Deviation 4.20	15.75 score on a scale Standard Deviation 2.82
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	12.88 score on a scale Standard Deviation 3.03
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	13.25 score on a scale Standard Deviation 4.12

PRIMARY outcome

Timeframe: baseline, 1-month, and 3-month visits

Population: Thirty-five participants completed all aspects of the study (19 intervention, 16 control)

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.

Outcome measures

Measure	HRVBF n=19 Participants 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).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.	Control n=16 Participants Usual Care
Changes From Baseline Cognitive Function at 1 and 3 Months Baseline_MMSE	18.84 score on a scale Standard Error 3.88	20.00 score on a scale Standard Error 3.48
Changes From Baseline Cognitive Function at 1 and 3 Months 1-month_MMSE	21.68 score on a scale Standard Error 4.23	21.00 score on a scale Standard Error 3.46
Changes From Baseline Cognitive Function at 1 and 3 Months 3-month_MMSE	23.74 score on a scale Standard Error 3.86	22.38 score on a scale Standard Error 3.34

PRIMARY outcome

Timeframe: baseline, 1-month, and 3-month visits

Population: Thirty-five participants completed all aspects of the study (19 intervention, 16 control)

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.

Outcome measures

Measure	HRVBF n=19 Participants 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).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.	Control n=16 Participants Usual Care
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	45.31 score on a scale Standard Deviation 12.31
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	54.38 score on a scale Standard Deviation 14.48
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 22.50	65.00 score on a scale Standard Deviation 18.07

PRIMARY outcome

Timeframe: baseline, 1-month, and 3-month visits

Population: Thirty-five participants completed all aspects of the study (19 intervention, 16 control)

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.

Outcome measures

Measure	HRVBF n=19 Participants 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).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.	Control n=16 Participants Usual Care
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	2.38 ms Standard Deviation 0.18
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	2.50 ms Standard Deviation 0.15
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	2.46 ms Standard Deviation 0.14
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	2.58 ms Standard Deviation 0.17
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	2.43 ms Standard Deviation 0.19
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	2.52 ms Standard Deviation 0.19

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	HRVBF n=19 Participants 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).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.	Control n=16 Participants Usual Care
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	3.79 ms^2 Standard Deviation 0.79
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	3.51 ms^2 Standard Deviation 0.39
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	4.44 ms^2 Standard Deviation 0.56
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	3.80 ms^2 Standard Deviation 0.52
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	3.73 ms^2 Standard Deviation 0.47
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	4.58 ms^2 Standard Deviation 0.40
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	3.85 ms^2 Standard Deviation 0.60
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 0.50	3.52 ms^2 Standard Deviation 0.51
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	4.59 ms^2 Standard Deviation 0.45

Adverse Events

HRVBF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yu-Ju Chen

National Defense Medical Center, Taiwan

Phone: 886-287923100

Email: judychen37@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place