Condition or disease | Intervention/treatment | Phase |
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Diabetes Mellitus, Type 2 | Other: Whole body Vibration exercise | Phase 3 |
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 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 |
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No Intervention: Controls
Subjects under treatment for diabetes will receive the standard treatment for their condition.
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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.
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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.
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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 |
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.
Exclusion Criteria:• Patients with severe motor handicap and amputations of pelvic members.
Contact: Gerardo Rodríguez Reyes, MS | +525559991000 ext 13221 | grodriguezreyes@gmail.com |
Mexico | |
Instituto Nacional de Rehabilitacion | Recruiting |
Mexico City, DF, Mexico, 14389 | |
Contact: Gerardo Rodriguez Reyes, MS 5559991000 ext 13221 grodriguezreyes@gmail.com |
Tracking Information | |||||
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First Submitted Date ICMJE | May 17, 2019 | ||||
First Posted Date ICMJE | May 21, 2019 | ||||
Last Update Posted Date | August 26, 2019 | ||||
Actual Study Start Date ICMJE | April 4, 2017 | ||||
Estimated Primary Completion Date | December 20, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Effect of Whole-body Vibration on TcPO2 | ||||
Official Title ICMJE | Intervention Project for Diabetic Foot Prevention Through the Development of a Vibratory Therapy Program at the National Rehabilitation Institute LGII | ||||
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | 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 |
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Condition ICMJE | Diabetes Mellitus, Type 2 | ||||
Intervention ICMJE | 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.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
80 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 2020 | ||||
Estimated Primary Completion Date | December 20, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
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.
Exclusion Criteria:• Patients with severe motor handicap and amputations of pelvic members.
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years to 69 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Mexico | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03957811 | ||||
Other Study ID Numbers ICMJE | 2416 2234 ( Other Identifier: Instituto Nacional de Ciencias Médicas y Nutrición ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Gerardo Rodríguez Reyes, Instituto Nacional de Rehabilitacion | ||||
Study Sponsor ICMJE | Instituto Nacional de Rehabilitacion | ||||
Collaborators ICMJE | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Instituto Nacional de Rehabilitacion | ||||
Verification Date | August 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |