N/A
N=40
Effects of Biofeedback in Patients With Acute Cerebral Infarction
Acute Ischemic Stroke · Biofeedback · Autonomic Dysfunction, Cognitive Function · Psychological Distress
Bottom Line
View on ClinicalTrials.gov: NCT03516227 ↗Enrolled (actual)
40
Serious AEs
—
Results posted
Oct 2019
Primary outcome: Primary: Changes From Baseline Psychological Distress (Anxiety and Depression) at 1 and 3 Months — 14.74; 14.75; 13.11; 14.25 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- heart rate variability biofeedback (Behavioral)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- National Defense Medical Center, Taiwan
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes From Baseline Psychological Distress (Anxiety and Depression) at 1 and 3 Months |
14.74; 14.75; 13.11; 14.25; 12.79; 15.38 | — |
| PRIMARY Changes From Baseline Cognitive Function at 1 and 3 Months |
18.84; 20.00; 21.68; 21.00; 23.74; 22.38 | — |
| PRIMARY Changes From Baseline Capabilities of Activities of Daily Living at 1 and 3 Months |
45.00; 45.31; 54.47; 54.38; 67.11; 65.00 | — |
| PRIMARY Changes From Baseline Autonomic Function (Time-domain of Heart Rate Variability) at 1 and 3 Months |
2.24; 2.38; 2.37; 2.50; 2.44; 2.46 | — |
| PRIMARY Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months |
3.41; 3.79; 3.27; 3.51; 4.14; 4.44 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03516227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.