Back to resultsEffect of Whole-body Vibration on TcPO2 (WBV)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Whole body Vibration exercise
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
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.
Sites / Locations
- Instituto Nacional de RehabilitacionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Controls
Intervention
Arm Description
Subjects under treatment for diabetes will receive the standard treatment for their condition.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03957811
First Posted
May 17, 2019
Last Updated
August 21, 2019
Sponsor
Instituto Nacional de Rehabilitacion
Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1. Study Identification
Unique Protocol Identification Number
NCT03957811
Brief Title
Effect of Whole-body Vibration on TcPO2
Acronym
WBV
Official Title
Intervention Project for Diabetic Foot Prevention Through the Development of a Vibratory Therapy Program at the National Rehabilitation Institute LGII
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
December 20, 2019 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Rehabilitacion
Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Controls
Arm Type
No Intervention
Arm Description
Subjects under treatment for diabetes will receive the standard treatment for their condition.
Arm Title
Intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Whole body Vibration exercise
Intervention Description
Intervention will consist of sessions of exercise on a whole body vibration platform, three times a week for 12 weeks.
Primary Outcome Measure Information:
Title
Effect of whole body vibration on TcPO2 levels
Description
To know the effect of whole body vibration on TcPO2 levels measured in the foot in patients with type 2 diabetes
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerardo Rodríguez Reyes, MS
Phone
+525559991000
Ext
13221
Email
grodriguezreyes@gmail.com
Facility Information:
Facility Name
Instituto Nacional de Rehabilitacion
City
Mexico City
State/Province
DF
ZIP/Postal Code
14389
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerardo Rodriguez Reyes, MS
Phone
5559991000
Ext
13221
Email
grodriguezreyes@gmail.com
12. IPD Sharing Statement
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Effect of Whole-body Vibration on TcPO2
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