Clinical trial NCT03957811: Effect of Whole-body Vibration on TcPO2
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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Instituto Nacional de Rehabilitacion
Sponsor class: OTHER_GOV
Collaborators: name: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
First posted: 2019-05-21
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

Primary outcomes:
measure: Effect of whole body vibration on TcPO2 levels
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Rehabilitacion
state: DF
Study officials:
References: