Clinical trial NCT01861392: Analisys of Neuromuscular Response, Postural Balance and Quality of Life of Diabetics Type 2 After Sensory-motor Training: Blind Random Controled Clinical Trial
Official title: Analisys of Neuromuscular Response, Postural Balance and Quality of Life of Diabetics Type 2 After Sensory-motor Training: Blind Random Controled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Quality of Life
Exercise Therapy
Postural Balance
Keywords: postural balance sensory motor trayning physical therapy modalities diabetes mellitus
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Postural balance training diabetic type 2
timeFrame: four years
Secondary outcomes:
measure: Quality of life of diabetics type 2
timeFrame: four years
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Rinaldo Roberto de Jesus Guirro
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Ariane H M Pletsch, PHD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Rinaldo Roberto Jesus Guirro, PHD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.