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Effect of Whole-body Vibration on TcPO2 (WBV)

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ClinicalTrials.gov Identifier: NCT03957811
Recruitment Status : Unknown
Verified August 2019 by Gerardo Rodríguez Reyes, Instituto Nacional de Rehabilitacion.
Recruitment status was:  Recruiting
First Posted : May 21, 2019
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Information provided by (Responsible Party):
Gerardo Rodríguez Reyes, Instituto Nacional de Rehabilitacion

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: Whole body Vibration exercise Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intervention Project for Diabetic Foot Prevention Through the Development of a Vibratory Therapy Program at the National Rehabilitation Institute LGII
Actual Study Start Date : April 4, 2017
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : June 2020
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Effect of whole body vibration on TcPO2 levels [ Time Frame: 12 weeks ]
    To know the effect of whole body vibration on TcPO2 levels measured in the foot in patients with type 2 diabetes


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957811


Contacts
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Contact: Gerardo Rodríguez Reyes, MS +525559991000 ext 13221 grodriguezreyes@gmail.com

Locations
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Mexico
Instituto Nacional de Rehabilitacion Recruiting
Mexico City, DF, Mexico, 14389
Contact: Gerardo Rodriguez Reyes, MS    5559991000 ext 13221    grodriguezreyes@gmail.com   
Sponsors and Collaborators
Instituto Nacional de Rehabilitacion
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
More Information
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Responsible Party: Gerardo Rodríguez Reyes, Medical Science Researcher, Instituto Nacional de Rehabilitacion
ClinicalTrials.gov Identifier: NCT03957811    
Other Study ID Numbers: 2416
2234 ( Other Identifier: Instituto Nacional de Ciencias Médicas y Nutrición )
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases