NCT00904761

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2001

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2002

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
Last Updated

December 28, 2012

Status Verified

November 1, 2012

Enrollment Period

7 months

First QC Date

May 18, 2009

Last Update Submit

December 27, 2012

Conditions

Diabetes Mellitus

Keywords

diabetes mellitusautonomic neuropathyexercise trainingexercise capacityheart rate variability

Outcome Measures

Primary Outcomes (2)

  • heart rate variability

    8 weeks

  • exercise capacity

    8 weeks

Study Arms (1)

exercise

EXPERIMENTAL

arm: intervention

Other: exercise training

Interventions

exercise trainingOTHER

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

exercise

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • heart disease
  • neuro-musculo-skeletal diseases
  • taking any medication that may affect HRV (such as α or β-blockers)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ying-Tai Wu, Doctor

    National Taiwan University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2009

First Posted

May 20, 2009

Study Start

October 1, 2001

Primary Completion

May 1, 2002

Study Completion

May 1, 2002

Last Updated

December 28, 2012

Record last verified: 2012-11

Locations

TW(1)