Effects of Physical Training on Heart Rate Variability and Exercise Capacity in Diabetes With Autonomic Neuropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00904761
First received: May 18, 2009
Last updated: December 27, 2012
Last verified: November 2012
  Purpose

This study aimed to investigate effects of physical training on exercise capacity and changes of heart rate variability (HRV) at rest, during exercise, and post-exercise in the patient with diabetes with autonomic neuropathy (DAN).


Condition Intervention
Diabetes Mellitus
Other: exercise training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effects of Physical Training on Heart Rate Variability and Exercise Capacity in Diabetes With Autonomic Neuropathy

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • heart rate variability [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • exercise capacity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Study Start Date: October 2001
Study Completion Date: May 2002
Primary Completion Date: May 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: exercise
arm: intervention
Other: exercise training
The exercise group took supervised aerobic training twice per week at hospital and thrice per week at home for eight weeks at the intensity of 60-70% VO2peak

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged under 65 years old
  • receiving regular treatment
  • HbA1c < 8.0
  • decreased HR response in deep breathing maneuver

Exclusion Criteria:

  • heart disease
  • neuro-musculo-skeletal diseases
  • taking any medication that may affect HRV (such as α or β-blockers)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904761

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Ying-Tai Wu, Doctor National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00904761     History of Changes
Other Study ID Numbers: 25670
Study First Received: May 18, 2009
Last Updated: December 27, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
diabetes mellitus
autonomic neuropathy
exercise training
exercise capacity
heart rate variability

Additional relevant MeSH terms:
Diabetes Mellitus
Nervous System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014