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

NCT01868698 | Completed DMC

• 1 other identifier: U1111-1143-8004
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Peripheral Arterial Disease

Keywords

Physical Therapy Modalities; Electric Stimulation Therapy; Hyperthermia, Induced; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Doppler ultrasound

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

  1 years

Study Arms (3)

Kinesiotherapy

EXPERIMENTAL

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

Other: Kinesiotherapy

shortwave diathermy

EXPERIMENTAL

Will be applied for 20 minutes on the lower limbs.

Other: shortwave diathermy

high-voltage electrical stimulation

EXPERIMENTAL

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

Other: high-voltage electrical stimulation

Interventions

high-voltage electrical stimulation OTHER

high-voltage electrical stimulation

Kinesiotherapy OTHER

Kinesiotherapy

shortwave diathermy OTHER

shortwave diathermy

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of São Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus; Peripheral Arterial Disease; Hyperthermia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Rinaldo Guirro, PhD, Professor

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 4, 2013
• Study Start: January 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2012
• Last Updated: June 4, 2013

Record last verified: 2013-05

Locations

BR (1)