Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Whole-body Vibration on TcPO2 (WBV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03957811
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Collaborator:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Information provided by (Responsible Party):
Gerardo Rodríguez Reyes, 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.

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, standrad 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.


Layout table for study information
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

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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 amputatins 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.

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
Layout table for location contacts
Contact: Gerardo Rodríguez Reyes, MS +525559991000 ext 13221 grodriguezreyes@gmail.com

Locations
Layout table for location information
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

Layout table for additonal information
Responsible Party: Gerardo Rodríguez Reyes, Medical Science Researcher, Instituto Nacional de Rehabilitacion
ClinicalTrials.gov Identifier: NCT03957811     History of Changes
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: May 21, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases