Clinical trial NCT03516227: Effects of Biofeedback in Patients With Acute Cerebral Infarction
Official title: Effects of Biofeedback Combined With Abdominal Breathing on Physiological and Psychological Aspects in Patients With Acute Cerebral Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Biofeedback
Autonomic Dysfunction, Cognitive Function
Psychological Distress
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2018-05-04
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Study protocol Participants who provided signed consent were randomly assigned to HRVBF intervention or control group. They underwent baseline measurements of demographics, psychological distress, cognitive impairment, ADL capabilities, and autonomic function. Random numbers from the Bernoulli distribution were calculated using the Excel BINOMDIST function, and concealed in an opaque envelope, until participants' baseline measurements were completed.

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. psychological distress, cognitive impairment, ADL capabilities, and autonomic function (represented by HRV) were re-assessed at one, and 3-months after the intervention, by an independent investigator blinded to group assignment.

HRVBF intervention protocol The HRVBF protocol was modified from Lehrer's HRV biofeedback manual.20 A noninvasive visual biofeedback system (NeXus-10 with BioTrace+, Mind Media B.V., Netherlands) and a laptop computer were used for the intervention. Participants in the HRVBF group received four, one-on-one bedside training sessions (20-minutes a day for 4 days). The first session (Day 1) was focused on teaching patients to breath slowly (6-8 breaths-per-minute) and to extend their expiratory phase using pursed-lip breathing. Also, respiration sensors for tracking breathing pace were introduced. The second session (day 2) was focused on teaching patients diaphragmatic breathing in conjunction with pursed-lip breathing, and to use respiratory sensors to pace breathing (6 breaths a minute). The third and fourth sessions (days 3 and 4) were focused on reviewing diaphragmatic breathing, pursed-lip breathing, and teaching patients to breathe in-phase with their heart rate changes. Additionally, participants were encouraged to practice slow diaphragmatic and pursed-lip breathing, on their own, with the aid of the hand-held biofeedback device, for 10 minutes, twice-a-day, during the 4-day training period.

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

Primary outcomes:
measure: Changes From Baseline Psychological Distress (Anxiety and Depression) at 1 and 3 Months
timeFrame: baseline, 1-month, and 3-month visits
measure: Changes From Baseline Cognitive Function at 1 and 3 Months
timeFrame: baseline, 1-month, and 3-month visits
measure: Changes From Baseline Capabilities of Activities of Daily Living at 1 and 3 Months
timeFrame: baseline, 1-month, and 3-month visits
measure: Changes From Baseline Autonomic Function (Time-domain of Heart Rate Variability) at 1 and 3 Months
timeFrame: baseline, 1-month, and 3-month visits
measure: Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months
timeFrame: baseline, 1-month, and 3-month visits
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Defense Medical Center
name: Yu-Ju Chen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: