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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Resistance training associated with vibration
Resistance training associated with vibration sham
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Blood Flow Velocity, Skin Temperature, Postural Balance, Combined Modality Therapy, Vibration, Resistance Training

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • François Talles Medeiros RodriguesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Resistance training associated with vibration

Resistance training associated with sham

Control group

Arm Description

The workout will be held three times a week and will last a total of 12 weeks (3 months) for 45 minutes.

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.

Will not be submitted to any physical intervention. It continues in your daily life with only monitoring via phone callings. Guidelines about foot care.

Outcomes

Primary Outcome Measures

Peripheral circulation
Vascular Doppler ultrasound (UVD)
Functional performance
Timed Up and Go Test (TUG)
Peripheral circulation
Infrared Thermography (TI)

Secondary Outcome Measures

Static postural alignment
Optoeletrônico system SMART DX100
Plantar pressure distribution
Baropodometry

Full Information

First Posted
February 2, 2018
Last Updated
February 12, 2020
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT03443986
Brief Title
Effect of Resistance Training Associated With Whole-Body Vibration in Diabetes
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
August 8, 2019 (Actual)
Study Completion Date
April 8, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus, Blood Flow Velocity, Skin Temperature, Postural Balance, Combined Modality Therapy, Vibration, Resistance Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
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).
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Resistance training associated with vibration
Arm Type
Experimental
Arm Description
The workout will be held three times a week and will last a total of 12 weeks (3 months) for 45 minutes.
Arm Title
Resistance training associated with sham
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Will not be submitted to any physical intervention. It continues in your daily life with only monitoring via phone callings. Guidelines about foot care.
Intervention Type
Other
Intervention Name(s)
Resistance training associated with vibration
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Resistance training associated with vibration sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
Peripheral circulation
Description
Vascular Doppler ultrasound (UVD)
Time Frame
12 weeks
Title
Functional performance
Description
Timed Up and Go Test (TUG)
Time Frame
12 weeks
Title
Peripheral circulation
Description
Infrared Thermography (TI)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Static postural alignment
Description
Optoeletrônico system SMART DX100
Time Frame
12 weeks
Title
Plantar pressure distribution
Description
Baropodometry
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
François Talles Medeiros Rodrigues
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
51020240
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Talles M Rodrigues, Msc
Phone
81998432083
Email
francoismedeirosfisiot@gmail.com

12. IPD Sharing Statement

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

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