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

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT01868698
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 3
• Duration (Months): 36
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Peripheral Arterial Disease	Other: high-voltage electrical stimulation; Other: Kinesiotherapy; Other: shortwave diathermy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Doppler ultrasound [1 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 90 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Women

• Diagnosis of diabetes

• Diagnosis of peripheral arterial disease

Exclusion Criteria:

• Regular physical activity

• Smokers

• Thrombosis active

• Severe peripheral arterial disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of São Paulo	Ribeirão Preto	São Paulo	Brazil	14049-900

Sponsors and Collaborators

• University of Sao Paulo

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Rinaldo Roberto de Jesus Guirro, PhD, Professor, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT01868698
• Other Study ID Numbers: U1111-1143-8004
• First Posted: Jun 4, 2013
• Last Update Posted: Jun 4, 2013
• Last Verified: May 1, 2013

• Keywords provided by Rinaldo Roberto de Jesus Guirro, PhD, Professor, University of Sao Paulo: Physical Therapy Modalities; Electric Stimulation Therapy; Hyperthermia, Induced; Diabetes Mellitus
• Additional relevant MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases

Study Results

No Results Posted as of Jun 4, 2013