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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 : Not yet recruiting
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Maria das Graças Rodrigues de Araújo, Universidade Federal de Pernambuco

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: Resistance training associated with vibration Other: Resistance training associated with vibration sham Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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
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
Estimated Study Start Date : February 26, 2018
Estimated Primary Completion Date : October 5, 2018
Estimated Study Completion Date : February 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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.

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.



Primary Outcome Measures :
  1. Peripheral circulation [ Time Frame: 12 weeks ]
    Vascular Doppler ultrasound (UVD)

  2. Functional performance [ Time Frame: 12 weeks ]
    Timed Up and Go Test (TUG)

  3. Peripheral circulation [ Time Frame: 12 weeks ]
    Infrared Thermography (TI)


Secondary Outcome Measures :
  1. Static postural alignment [ Time Frame: 12 weeks ]
    Optoeletrônico system SMART DX100

  2. Plantar pressure distribution [ Time Frame: 12 weeks ]
    Baropodometry



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Maria das Graças Rodrigues de Araújo, Professor, PhD, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT03443986     History of Changes
Other Study ID Numbers: Resistance, Vibration and DM
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maria das Graças Rodrigues de Araújo, Universidade Federal de Pernambuco:
Diabetes Mellitus
Blood Flow Velocity
Skin Temperature
Postural Balance
Combined Modality Therapy
Vibration
Resistance Training

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases