Analisys of Neuromuscular Response, Postural Balance and Quality of Life of Diabetics Type 2 After Sensory-motor Training: Blind Random Controled Clinical Trial

NCT01861392 | Unknown DMC

• 1 other identifier: U1111-1143-3618
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The individual's ability to sustain itself in the upright position, effectively adjusting the body's movements and reacting to external stimuli, postural control strategies represent essential activities of daily living. Diabetes mellitus type 2 (DM-2) is considered a more problem of Public Health as having complications deficit in functional performance of the lower limbs and falls, which can interfere with the maintenance of balance, and is a strong predictor of functional limitations self referred. Aim: To assess quality of life and the answers neuromuscular balance and baropodometric after sensory-motor training in patients with type 2 diabetes. Method: To be recruited 50 volunteers aged between 45 to 64 years with DM-2, of both sexes, divided into two groups: 1) Guidelines and 2) Guidelines + sensory-motor training. Biomechanical data will be collected (balance, baropodometry, electromyography strength and joint position sense), as well as questionnaires ADDQoL and BESTest. The intervention will be twice a week for 45 minutes for 12 weeks, divided into three phases: heating, sensory-motor training and cool-down, with monitoring of blood pressure and blood glucose. There will be a follow up after 3 months of intervention. Statistical analysis will be used normality test to verify the data distribution and consistent statistical test for the appropriate comparisons within and between groups, and adopted a significance level of 5%. Expected Results: Considering previous studies that demonstrate improvement in postural balance static and dynamic responses under the forward training protocol sensorimotor disease Diabetes mellitus type 2, is expected to improve neuromuscular, balance, distribution plant, the joint position sense and the quality of life of voluntary DM-2. Keywords: physical therapy modalities, exercise therapy, postural balance, Diabetes Mellitus, quality of life.

Conditions

Diabetes Mellitus; Quality of Life; Exercise Therapy; Postural Balance

Keywords

postural balance sensory motor trayning physical therapy modalities diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Postural balance training diabetic type 2

  four years

Secondary Outcomes (1)

• Quality of life of diabetics type 2

  four years

Study Arms (2)

sensory-motor training

ACTIVE COMPARATOR

Guidelines + sensory-motor training.Evaluation Biomechanical data will be collected (balance, baropodometry, electromyography strength and joint position sense), as well as questionnaires ADDQoL and BESTest. The intervention will be twice a week for 45 minutes for 12 weeks, divided into three phases: heating, sensory-motor training and cool-down, with monitoring of blood pressure and blood glucose.

Procedure: sensorio-motor training

guidelines

ACTIVE COMPARATOR

receive the same guidelines and reviews that group orientation and training sensorineural engine and will be guided home exercises for postural twice a week 45 minutes for 12 weeks.

Procedure: sensorio-motor training

Interventions

sensorio-motor training PROCEDURE

Also known as: quality of life

guidelines; sensory-motor training

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of diabetes mellitus type 2 with controlled blood glucose
• Absence of skin lesions or fractures of the lower limbs in the last 6 months -Plantar malformations
• Severe postural abnormalities and limb length difference.

You may not qualify if:

• Use of medications that can have negative effects on the function of cognition, attention and psychomotor (ie, opioids, antiepileptics, anxiolytics, antipsychotics, hypnotics and sedatives)
• Diagnosis of cardiovascular, neurological, rheumatological and musculoskeletal disorders that may interfere with activities of daily living
• Presence of vestibular disorders

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Rinaldo Roberto de Jesus Guirro

Ribeirão Preto, São Paulo, Brazil

Location

Related Publications (5)

• Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.

  PMID: 15111519 BACKGROUND

• Suprak DN. Shoulder joint position sense is not enhanced at end range in an unconstrained task. Hum Mov Sci. 2011 Jun;30(3):424-35. doi: 10.1016/j.humov.2011.02.003. Epub 2011 Mar 27.

  PMID: 21444119 BACKGROUND

• Vandekerckhove M, Vermeire E, Weeren A, Van Royen P. Validation of the Diabetes Obstacles Questionnaire (DOQ) to assess obstacles in living with type 2 diabetes in a Belgian population. Prim Care Diabetes. 2009 Feb;3(1):43-7. doi: 10.1016/j.pcd.2009.02.003. Epub 2009 Mar 4.

  PMID: 19264569 BACKGROUND

• Song CH, Petrofsky JS, Lee SW, Lee KJ, Yim JE. Effects of an exercise program on balance and trunk proprioception in older adults with diabetic neuropathies. Diabetes Technol Ther. 2011 Aug;13(8):803-11. doi: 10.1089/dia.2011.0036. Epub 2011 May 11.

  PMID: 21561371 BACKGROUND

• Borges NCS, Pletsch AHM, Buzato MB, Terada NAY, Cruz FMFD, Guirro RRJ. The effect of proprioceptive training on postural control in people with diabetes: A randomized clinical trial comparing delivery at home, under supervision, or no training. Clin Rehabil. 2021 Jul;35(7):988-998. doi: 10.1177/0269215521989016. Epub 2021 Jan 28.

  PMID: 33508955 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Ariane H M Pletsch, PHD Student

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Rinaldo Roberto Jesus Guirro, PHD

  University of Sao Paulo

  STUDY DIRECTOR

Central Study Contacts

Ariane H.M Pletsch, PHD student

CONTACT

+551636020462; ariane_mansano@usp.br

Rinaldo Roberto Jesus Guirro, PHD

CONTACT

+551636024584; rguirro@fmrp.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD Professor

Study Record Dates

• First Submitted: May 21, 2013
• First Posted: May 23, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 23, 2013

Record last verified: 2013-05

Locations

BR (1)