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

Primary Purpose

Diabetes, Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
high-voltage electrical stimulation
Kinesiotherapy
shortwave diathermy
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring Physical Therapy Modalities, Electric Stimulation Therapy, Hyperthermia, Induced, Diabetes Mellitus

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Kinesiotherapy

shortwave diathermy

high-voltage electrical stimulation

Arm Description

Will be made active and resisted exercises of the lower limbs.

Will be applied for 20 minutes on the lower limbs.

The therapeutic current will be applied for 20 minutes on lower limbs.

Outcomes

Primary Outcome Measures

Doppler ultrasound
Will evaluate the blood flow in the following arteries of the lower limbs: femoral, popliteal, posterior tibial and dorsalis pedis.

Secondary Outcome Measures

Full Information

First Posted
May 30, 2013
Last Updated
May 30, 2013
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01868698
Brief Title
Effects of High Voltage Electrical Stimulation, Shortwave Diathermy and Kinesiotherapy on Arterial Blood Flow in the Lower Limbs of Diabetic Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Peripheral Arterial Disease
Keywords
Physical Therapy Modalities, Electric Stimulation Therapy, Hyperthermia, Induced, Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesiotherapy
Arm Type
Experimental
Arm Description
Will be made active and resisted exercises of the lower limbs.
Arm Title
shortwave diathermy
Arm Type
Experimental
Arm Description
Will be applied for 20 minutes on the lower limbs.
Arm Title
high-voltage electrical stimulation
Arm Type
Experimental
Arm Description
The therapeutic current will be applied for 20 minutes on lower limbs.
Intervention Type
Other
Intervention Name(s)
high-voltage electrical stimulation
Intervention Type
Other
Intervention Name(s)
Kinesiotherapy
Intervention Type
Other
Intervention Name(s)
shortwave diathermy
Primary Outcome Measure Information:
Title
Doppler ultrasound
Description
Will evaluate the blood flow in the following arteries of the lower limbs: femoral, popliteal, posterior tibial and dorsalis pedis.
Time Frame
1 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women Diagnosis of diabetes Diagnosis of peripheral arterial disease Exclusion Criteria: Regular physical activity Smokers Thrombosis active Severe peripheral arterial disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rinaldo Guirro, PhD, Professor
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of São Paulo
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil

12. IPD Sharing Statement

Links:
URL
http://www.fmrp.usp.br
Description
Related Info

Learn more about this trial

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

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