Effects of Biofeedback in Patients With Acute Cerebral Infarction

NCT03516227 | Completed Results

• 1 other identifier: NDMCTaiwan
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Ischemic Stroke; Biofeedback; Autonomic Dysfunction, Cognitive Function; Psychological Distress

Outcome Measures

Primary Outcomes (5)

• 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.

  baseline, 1-month, and 3-month visits

• 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.

  baseline, 1-month, and 3-month visits

• 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.

  baseline, 1-month, and 3-month visits

• 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.

  baseline, 1-month, and 3-month visits

• 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.

  baseline, 1-month, and 3-month visits

Study Arms (2)

HRVBF

EXPERIMENTAL

Heart rate variability biofeedback

Behavioral: heart rate variability biofeedback

Control

NO INTERVENTION

Usual Care

Interventions

heart rate variability biofeedback BEHAVIORAL

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.

HRVBF

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead

MeSH Terms

Conditions

Ischemic Stroke; Primary Dysautonomias

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Autonomic Nervous System Diseases

Results Point of Contact

• Title: Dr. Yu-Ju Chen
• Organization: National Defense Medical Center, Taiwan

judychen37@gmail.com

886-287923100

Study Officials

• Yu-Ju Chen, Ph.D.

  National Defense Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 4, 2018
• Study Start: November 9, 2015
• Primary Completion: June 26, 2016
• Study Completion: August 3, 2016
• Last Updated: October 11, 2019
• Results First Posted: October 11, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share