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Enhancing the Vagal Tone in Prediabetes Individuals

NCT03616275 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-02-26

No results posted yet for this study

Summary

This is a 2-year course of study. A randomized control trial will be conducted, in which 90 prediabetes individuals will be recruited and randomly assigned them into the wait-list control group or experimental group to test the effectiveness of 8 once-a-week, individual, 20-min sessions of HRV biofeedback on modulating vagal tone, glycemic control, psychological wellbeing, and inflammatory status in this population. Its longitudinal effects will be evaluated after 3- and 6-month follow-up.

Conditions

  • Prediabetes
  • Autonomic Nervous System Imbalance
  • Poor Glycemic Control
  • Psychological Distress

Interventions

OTHER

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.

Sponsors & Collaborators

  • National Defense Medical Center, Taiwan

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-17
Primary Completion
2019-07-31
Completion
2019-07-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

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 NCT03616275 on ClinicalTrials.gov