CClinicalTrials.gg
Status unknownNCT03443986Updated Feb 13, 2020

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

An interventional study of Resistance training associated with vibration and Resistance training associated with vibration sham in Diabetes Mellitus, Type 2, sponsored by Universidade Federal de Pernambuco. Status unknown at 1 site in Brazil. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-02-13.

Sponsored by Universidade Federal de Pernambuco · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
60 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • Diabetes Mellitus
  • Blood Flow Velocity
  • Skin Temperature
  • Postural Balance
  • Combined Modality Therapy
  • Vibration
  • Resistance Training
03

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Change in the drug program in during the research
  • Performing other physical activity during the training
  • Hypertensive Peaks during treatment
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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

  • 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.

Interventions

  • OtherResistance 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.

  • OtherResistance 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.

05

What researchers measure

Primary outcomes

  1. Peripheral circulation

    Vascular Doppler ultrasound (UVD)

    Time frame: 12 weeks

  2. Functional performance

    Timed Up and Go Test (TUG)

    Time frame: 12 weeks

  3. Peripheral circulation

    Infrared Thermography (TI)

    Time frame: 12 weeks

Secondary outcomes

  1. Static postural alignment

    Optoeletrônico system SMART DX100

    Time frame: 12 weeks

  2. Plantar pressure distribution

    Baropodometry

    Time frame: 12 weeks

06

Study locations

1 of 1 sites recruiting
  • François Talles Medeiros Rodrigues
    Recife, Pernambuco 51020240, Brazil
    Recruiting
07

Registry details

Key details

Study ID
NCT03443986
Lead sponsor
Universidade Federal de Pernambuco
Responsible party
Maria das Graças Rodrigues de Araújo (Professor, PhD, Universidade Federal de Pernambuco) — Principal investigator
First posted
Feb 23, 2018
Start date
Feb 26, 2018
Primary completion
Aug 8, 2019
Completion
Apr 8, 2020 (estimated)
Last update
Feb 13, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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