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Effect of Resistance Training Associated With Whole-Body Vibration in Diabetes

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ClinicalTrials.gov Identifier: NCT03443986
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Maria das Graças Rodrigues de Araújo, Universidade Federal de Pernambuco

Tracking Information
First Submitted Date  ICMJE February 2, 2018
First Posted Date  ICMJE February 23, 2018
Last Update Posted Date February 13, 2020
Actual Study Start Date  ICMJE February 26, 2018
Actual Primary Completion Date August 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2018)
  • Peripheral circulation [ Time Frame: 12 weeks ]
    Vascular Doppler ultrasound (UVD)
  • Functional performance [ Time Frame: 12 weeks ]
    Timed Up and Go Test (TUG)
  • Peripheral circulation [ Time Frame: 12 weeks ]
    Infrared Thermography (TI)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2018)
  • Static postural alignment [ Time Frame: 12 weeks ]
    Optoeletrônico system SMART DX100
  • Plantar pressure distribution [ Time Frame: 12 weeks ]
    Baropodometry
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Resistance Training Associated With Whole-Body Vibration in Diabetes
Official Title  ICMJE Effect of Resistance Training Associated With Whole-Body Vibration Over the Peripheral Circulation and the Functional Performance of the Elderly With Type 2 Diabetes: Randomized Controlled Clinical Trial
Brief Summary

Introduction: Diabetes Mellitus (DM) is an important health condition of the population and its prevalence continues to grow due to population aging, economic development and urbanization. The exercise is an important factor of prevention and control, thereby decreasing the risk of metabolic diseases, cardiovascular diseases and improving the functionality of the patient with diabetes.

Objective: Evaluate the response of resistance training associated with whole-body vibration on peripheral circulation and functional performance of elderly with type 2 diabetes.

Methods: This is a clinical trial study, controlled, randomized and blinded, which will follow the guidelines established by the Consolidated Standards of Reporting Trials (CONSORT). Patients will be recruited in the light of the eligibility criteria and randomly divided into 3 groups: resistance training associated with whole body vibration (G1), resistance training associated with vibration sham (G2) and control group-guidelines about foot care (GC), establishing 36 treatment sessions, three times a week for the G1 and G2.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Three groups: resistance training associated with whole body vibration (G1), resistance training associated with vibration sham; (G2) and control group-guidelines about foot care (GC)
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

Triple: a researcher shall be exclusively responsible for the evaluations and reevaluations not having knowledge of what intervention

group the patient will enter. The patient will be allocated among three groups. After the final evaluations, all data will be analyzed by another researcher directed solely to that purpose. Therefore, there will be a triple blinding (researcher, patient and statistician).

Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Other: Resistance training associated with vibration
    The workout will be held three times a week and will last a total of 12 weeks (3 months) for 45 minutes, where there will be 5 minutes of heating, 19 minutes of exercise with load, 16 minutes of vibration and 5 minutes of slowdown.
  • Other: Resistance training associated with vibration sham
    he workout will be held three times a week and will last a total of 12 weeks (3 months) for 45 minutes, where there will be 5 minutes of heating, 19 minutes of exercise with load, 16 minutes of vibration "sham" and 5 minutes of slowdown.
Study Arms  ICMJE
  • Experimental: Resistance training associated with vibration
    The workout will be held three times a week and will last a total of 12 weeks (3 months) for 45 minutes.
    Intervention: Other: Resistance training associated with vibration
  • Sham Comparator: Resistance training associated with sham
    The workout will be held three times a week and will last a total of 12 weeks (3 months) for 45 minutes, where there will be 5 minutes of heating, 19 minutes of exercise with load, 16 minutes of vibration "sham" and 5 minutes of slowdown. The vibration sham; will be held with the disconnected platform. A device will be connected producing a noise similar to the sound of the connected platform for a time equivalent to the treatment protocol, since it will not be possible to distinguishing noticeably stimulate vibrator. Participants that will undergo false vibration will not have contact with those who carry out the real treatment.
    Intervention: Other: Resistance training associated with vibration sham
  • No Intervention: Control group
    Will not be submitted to any physical intervention. It continues in your daily life with only monitoring via phone callings. Guidelines about foot care.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 12, 2020)
60
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2018)
15
Estimated Study Completion Date  ICMJE April 8, 2020
Actual Primary Completion Date August 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Present overweight or obese class I, with BMI between 25.00 and 34.99 kg/m2 (WHO, 2009)
  • Be functionally independent
  • Having cognitive ability to respond and perform the exercisesevaluated by Mini-Mental State examination (MMSE), prepared by Folstein et al. (1975) and translation/modification proposed by Lawrence and van Heerden (2006), using as a bridge to cut to illiterate individuals = 19 points (BRAZIL, 2006)
  • Inactive (0 to 5 points) or less active (6 to 11 points) according to the Questionnaire of Habitual Physical Activity (QAFH)
  • Patients without severe foot deformities requiring therapeutic shoes
  • Do not have orthopedic deficiencies
  • No indications of deep vein thrombosis
  • Do not use locomotion auxiliary equipment

Exclusion Criteria:

  • Change in the drug program in during the research
  • Performing other physical activity during the training
  • Hypertensive Peaks during treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03443986
Other Study ID Numbers  ICMJE Resistance, Vibration and DM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maria das Graças Rodrigues de Araújo, Universidade Federal de Pernambuco
Study Sponsor  ICMJE Universidade Federal de Pernambuco
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidade Federal de Pernambuco
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP