Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2017-10-17
2019-07-31
Brief Summary
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Detailed Description
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Objective. To test the effectiveness of HRV biofeedback on the modulating vagal tone and further enhancing the psychoneuroimmunological integration related to glycemic control, anti-inflammatory reaction, and psychological wellbeing.
Research methods. In this 2-year RCT study, the investigators are planning to recruit 90 prediabetes individuals and randomly assigned them into wait-list control group or experimental group by using the random sequence of numbers generated from the Excel Bernoulli Function. Experimental group will receive 8 once-a-week, individual, 30-min sessions of HRV biofeedback and 1 session of healthy lifestyle education. During the biofeedback training period, subjects will be encouraged to self- home practice of resonant frequency breathing for 20 mins, twice-a-day. Control group will receive 1 session of healthy lifestyle education. All subjects will be repeatedly assessed at time of enrollment, post-training (8 weeks after enrollment), 3-month, and 6-month follow-up. Repeated assessments will include physiological measurements of HRV, BDNF, GAS6, HbA1c, CRP, IL- 6, FPG, and salivary cortisol, and psychological measurements of perceived stress, anxiety, and depression.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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HRV biofeedback group
8 once-a-week, individual, 30-min sessions of HRV biofeedback and 1 session of healthy lifestyle education
HRV biofeedback
HRV biofeedback protocol is modified from Lehrer's HRV biofeedback manual (2000), which had been successfully used to improve functioning and quality of life for patients with asthma and COPD. A noninvasive biofeedback system with a NeXus-10 with BioTrace+ (Mind Media B.V., Netherlands) and laptop computer will be used for biofeedback intervention. The intervention protocol is including paced breathing in resonant frequency, abdominal breathing and pursed-lip breathing, and visual biofeedback. The designed intervention protocol will include 8 once-a-week, individual, 20-min in hospital training sessions and twice-a-day, 20-min home self-practices.
control group
1 session of healthy lifestyle education
No interventions assigned to this group
Interventions
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HRV biofeedback
HRV biofeedback protocol is modified from Lehrer's HRV biofeedback manual (2000), which had been successfully used to improve functioning and quality of life for patients with asthma and COPD. A noninvasive biofeedback system with a NeXus-10 with BioTrace+ (Mind Media B.V., Netherlands) and laptop computer will be used for biofeedback intervention. The intervention protocol is including paced breathing in resonant frequency, abdominal breathing and pursed-lip breathing, and visual biofeedback. The designed intervention protocol will include 8 once-a-week, individual, 20-min in hospital training sessions and twice-a-day, 20-min home self-practices.
Eligibility Criteria
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Inclusion Criteria
* fasting blood glucose level of 100 to 125 mg/dl
* HbA1C value of 5.7% to 6.4%
Exclusion Criteria
* visual and hearing deficits
* the presence of arrhythmia
* previous diagnosed with diabetes
* any other serious physical illness (e.g. severe neurocognitive disorders or evidence of cor pulmonale) or psychiatric disorders
20 Years
ALL
No
Sponsors
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National Defense Medical Center, Taiwan
OTHER
Responsible Party
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Yu-Ju Chen
Associate Professor
Principal Investigators
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Yu-Ju Chen, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Defense Medical Center, Taiwan
Locations
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Tri-Service Medical Center
Taipei, , Taiwan
Countries
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Other Identifiers
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2-106-05005
Identifier Type: -
Identifier Source: org_study_id
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