Effect of Whole-body Vibration on TcPO2 (WBV)

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Whole body Vibration exercise

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • DF
    • Mexico City, DF, Mexico, 14389
      • Recruiting
      • Instituto Nacional De Rehabilitacion
      • Contact: Gerardo Rodriguez Reyes, MS; Phone Number: 13221 5559991000; Email: grodriguezreyes@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Controls; Subjects under treatment for diabetes will receive the standard treatment for their condition.
Experimental: Intervention; 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.	Other: Whole body Vibration exercise; Intervention will consist of sessions of exercise on a whole body vibration platform, three times a week for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of whole body vibration on TcPO2 levels	To know the effect of whole body vibration on TcPO2 levels measured in the foot in patients with type 2 diabetes	12 weeks

Collaborators and Investigators

• Sponsor: Instituto Nacional de Rehabilitacion
• Collaborators: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2017
• Primary Completion (Anticipated): December 20, 2019
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): August 26, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2416; 2234 (Other Identifier: Instituto Nacional de Ciencias Médicas y Nutrición)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No