WBV: Effect of Whole-body Vibration on TcPO2

Sponsor

Instituto Nacional de Rehabilitacion (Other)

Overall Status

Unknown status

CT.gov ID

NCT03957811

Collaborator

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Other)

Enrollment

Location

Arms

37.9

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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.

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

Study Type:

Interventional

Anticipated 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.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 :

Apr 4, 2017

Anticipated Primary Completion Date :

Dec 20, 2019

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

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.

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

Primary Outcome Measures

Effect of whole body vibration on TcPO2 levels [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

Criteria

Ages Eligible for Study:

40 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Instituto Nacional de Rehabilitacion	Mexico City	DF	Mexico	14389

Sponsors and Collaborators

Instituto Nacional de Rehabilitacion
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gerardo Rodríguez Reyes, Medical Science Researcher, Instituto Nacional de Rehabilitacion

ClinicalTrials.gov Identifier:

NCT03957811

Other Study ID Numbers:

2416
2234

First Posted:

May 21, 2019

Last Update Posted:

Aug 26, 2019

Last Verified:

Aug 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Aug 26, 2019