Effect of Whole-body Vibration on TcPO2

Intervention Project for Diabetic Foot Prevention Through the Development of a Vibratory Therapy Program at the National Rehabilitation Institute LGII

Sponsors

Lead Sponsor: Instituto Nacional de Rehabilitacion

Collaborator: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Source Instituto Nacional de Rehabilitacion
Brief Summary

In order to determine the effect of whole body vibration on TcPO2 levels in patients with type 2 diabetes, 40 subjects will undertake whole body vibration exercise three times a week for 12 weeks. TcPO2 will be measured before and after the intervention. A second control group with type 2 diabetes will also have TcPO2 levels measured before and after the 12 weeks of the study.

Detailed Description

Objective: To determine the effect of whole body vibration exercise on levels of TcPO2 measured in the feet of patients with type 2 diabetes, in order to create recommendations for prevention of diabetic foot.

Material and Methods: controlled open clinical trial consisting in 2 arms, as follows: 1) control group under care for type 2 diabetes, and 2) intervention group, who, in addition to the standard care, will undergo an exercise program of whole body vibration three times a week, with progressive intensity, for a period of 12 weeks. Partial pressure of transcutaneous oxygen (TcPO2) will be measured in the feet of the participants at baseline and after 12 weeks, with 40 patients per group.

Statistical analysis: demographic information of the subjects will be described as arithmetic means, standard deviation, percentages, frequencies. Comparison between groups will be done with Student t for independent data or Mann-Whitney U when convenient. Baseline and final measurements will be compared. inter and intra group comparisons will be made by repeated measurements. For qualitative values, chi square will be used. Multivariate analysis will be performed to control for confounding variables. The level of significance will be a value of 0.05.

Overall Status Recruiting
Start Date April 4, 2017
Completion Date June 2020
Primary Completion Date December 20, 2019
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Effect of whole body vibration on TcPO2 levels 12 weeks
Enrollment 80
Condition
Intervention

Intervention Type: Other

Intervention Name: Whole body Vibration exercise

Description: Intervention will consist of sessions of exercise on a whole body vibration platform, three times a week for 12 weeks.

Arm Group Label: Intervention

Eligibility

Criteria:

Inclusion Criteria:• Patients with diagnosis of type 2 diabetes less than or equal to six years, under care and having concluded the 4th or 5th medical visit.

- Non-smokers.

- Residents of Mexico City

- Both sexes.

- 40 to 69 years old.

- Agreeing to participate through signature of informed consent.

- HbA1c between 6.0 and 9.0 %.

- Blood pressure less than or equal to130/80.

- Total cholesterol ≤ 240 mg/dL, triglycerides ≤300 mg/dL.

- Stable weight over the last 6 months ( <10% variation).

Exclusion Criteria:• Patients with severe motor handicap and amputations of pelvic members.

- With exposed lesions in subcutaneous tissue (ulcers) in the sole of the foot, diabetic foot (Wagner 3 or more) or intermittent claudication.

- With important alterations in balance.

- With a recent surgery.

- Gravidity.

- Deep venous thrombosis.

- With pacemaker.

- Recent myocardial ischemia.

- Orthopedic implants.

- Recently-placed mammary prosthesis.

- Exoskeletal prosthesis.

- Discopathies.

- Neoplasia in the last 5 years.

- History of 2 episodes of severe hypoglycemia in the last year.

- Chronic kidney disease with creatinine clearance estimated at <60 ml/min.

- Severe non-proliferative retinopathy, uncontrolled macular edema.

- Hepatic failure (Child-Pugh "C") and/or heart failure (functional Class - NYHA-: III-IV).

- Patients with hemoglobinopathies, severe anemia (≤7.5 g/dL), known hemolytic disease.

Gender: All

Minimum Age: 40 Years

Maximum Age: 69 Years

Healthy Volunteers: No

Overall Contact

Last Name: Gerardo Rodríguez Reyes, MS

Phone: +525559991000

Phone Ext.: 13221

Email: [email protected]

Location
Facility: Status: Contact: Instituto Nacional de Rehabilitacion Gerardo Rodriguez Reyes, MS 5559991000 13221 [email protected]
Location Countries

Mexico

Verification Date

August 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Instituto Nacional de Rehabilitacion

Investigator Full Name: Gerardo Rodríguez Reyes

Investigator Title: Medical Science Researcher

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Controls

Type: No Intervention

Description: Subjects under treatment for diabetes will receive the standard treatment for their condition.

Label: Intervention

Type: Experimental

Description: Subjects under treatment for diabetes not diagnosed for diabetic foot will receive the standard treatment plus exercise on a vibrator platform for a period of 12 weeks.

Acronym WBV
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: There will be two parallel groups. One will receive the standard treatment for diabetes, and the other will receive standard treatment plus sessions of vibration exercise therapy.

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov