Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014