NCT01760707

Brief Summary

The purpose of the study was to investigate the effects of training on the exercise capability, balance performance, and microcirculation. Furthermore, to search the possible underlying mechanisms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Nov 2002

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
Last Updated

January 4, 2013

Status Verified

November 1, 2012

Enrollment Period

5 months

First QC Date

January 2, 2013

Last Update Submit

January 3, 2013

Conditions

Diabetes MellitusPeripheral Neuropathy

Keywords

Diabetes mellitusPeripheral neuropathyExerciseBalance performance

Outcome Measures

Primary Outcomes (1)

  • Exercise capacity

    oxygen consumption

    8 weeks

Secondary Outcomes (1)

  • maximal oxygen pulse

    8 weeks

Study Arms (2)

Exercise Training

EXPERIMENTAL

aerobic exercise training

Behavioral: exercise training

Control

ACTIVE COMPARATOR
Behavioral: usual care

Interventions

exercise trainingBEHAVIORAL
Exercise Training
usual careBEHAVIORAL
Control

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes with neuropathy.

You may not qualify if:

  • Central nerve system dysfunction, hemiparesis, motion tremor, other musculoskeletal disease that might effect the outcome measurements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Diabetes MellitusPeripheral Nervous System DiseasesMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesNeuromuscular DiseasesNervous System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ying-Tai Wu, PhD

    National Taiwan University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2013

First Posted

January 4, 2013

Study Start

November 1, 2002

Primary Completion

April 1, 2003

Study Completion

May 1, 2003

Last Updated

January 4, 2013

Record last verified: 2012-11

Locations

TW(1)