CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
heart rate variability biofeedbackbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03516227
NCT03516227N/ACompleted
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Effects of Biofeedback Combined With Abdominal Breathing on Physiological and Psychological Aspects in Patients With Acute Cerebral Infarction

National Defense Medical Center, Taiwan·interventional·Posted May 4, 2018·Updated Oct 11, 2019

In Brief

A clinical study evaluating heart rate variability biofeedback for Acute Ischemic Stroke and 3 related conditions. Completed, enrolled 40 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Ischemic Stroke, Biofeedback, Autonomic Dysfunction, Cognitive Function, Psychological Distress
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 4, 2018
Enrollment StartNov 9, 2015
Primary CompletionJun 26, 2016
Study CompletionAug 3, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.2 years ago

Interventions

heart rate variability biofeedbackbehavioral

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.