Effects of High Voltage Electrical Stimulation, Shortwave Diathermy and Kinesiotherapy on Arterial Blood Flow in the Lower Limbs of Diabetic Women

May 30, 2013 updated by: Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
Peripheral arterial disease (PAD) is a pathological condition limiting, resulting from a narrowing or occlusion of the artery diameter due to aneurysms, inflammation, atherosclerosis and thromboembolic events. One of the main risk factors for the development of DAP is diabetes mellitus due to its relation to the process of atherogenesis. Thus, the objective of this study is to evaluate the effects of three treatment modalities for PAD on the blood flow velocity. It is a crossover study. Fifteen women with diabetes receive three types of treatment, the order defined according draw: high voltage electrical stimulation, shortwave diathermy and kinesiotherapy. The blood flow of the lower limb will be assessed by Doppler ultrasound. The hypothesis of this study is that physical therapy resources increase the circulation of the lower limb.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14049-900
        • University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women
  • Diagnosis of diabetes
  • Diagnosis of peripheral arterial disease

Exclusion Criteria:

  • Regular physical activity
  • Smokers
  • Thrombosis active
  • Severe peripheral arterial disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Kinesiotherapy
Will be made active and resisted exercises of the lower limbs.
Other: Kinesiotherapy
EXPERIMENTAL: shortwave diathermy
Will be applied for 20 minutes on the lower limbs.
Other: shortwave diathermy
EXPERIMENTAL: high-voltage electrical stimulation
The therapeutic current will be applied for 20 minutes on lower limbs.
Other: high-voltage electrical stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Doppler ultrasound
Time Frame: 1 years
Will evaluate the blood flow in the following arteries of the lower limbs: femoral, popliteal, posterior tibial and dorsalis pedis.
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Rinaldo Guirro, PhD, Professor, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

May 30, 2013

First Submitted That Met QC Criteria

May 30, 2013

First Posted (ESTIMATE)

June 4, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 4, 2013

Last Update Submitted That Met QC Criteria

May 30, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1143-8004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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