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

NCT03443986 | Unknown DMC

• 1 other identifier: Resistance, Vibration and DM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Peripheral circulation

  Vascular Doppler ultrasound (UVD)

  12 weeks

• Functional performance

  Timed Up and Go Test (TUG)

  12 weeks

• Peripheral circulation

  Infrared Thermography (TI)

  12 weeks

Secondary Outcomes (2)

• Static postural alignment

  12 weeks

• Plantar pressure distribution

  12 weeks

Study Arms (3)

Resistance training associated with vibration

EXPERIMENTAL

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

Resistance training associated with sham

SHAM COMPARATOR

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

Control group

NO INTERVENTION

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

Resistance training associated with vibration OTHER

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.

Resistance training associated with vibration

Resistance training associated with vibration sham OTHER

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.

Resistance training associated with sham

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

François Talles Medeiros Rodrigues

Recife, Pernambuco, 51020240, Brazil

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Vibration

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Model Details: 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)

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 23, 2018
• Study Start: February 26, 2018
• Primary Completion: August 8, 2019
• Study Completion: April 8, 2020
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

BR (1)