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NCT00904761 Clinical Trial

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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00904761
Other study ID # 25670
Secondary ID
Status Completed
Phase N/A
First received May 18, 2009
Last updated December 27, 2012
Start date October 2001
Est. completion date May 2002

Study information
Verified date November 2012
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date May 2002
Est. primary completion date May 2002
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 65 Years
Eligibility 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 a or ß-blockers)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

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

Locations
Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary heart rate variability 8 weeks No
Primary exercise capacity 8 weeks No
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