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Effects of Biofeedback in Patients With Acute Cerebral Infarction

NCT03516227 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-10-11

Study results available
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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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • National Defense Medical Center, Taiwan

    lead OTHER

Principal Investigators

  • Yu-Ju Chen, Ph.D. · National Defense Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-09
Primary Completion
2016-06-26
Completion
2016-08-03

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03516227 on ClinicalTrials.gov