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

NCT ID: NCT01861392

Last Updated: 2013-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

sensory-motor training

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.

Group Type: ACTIVE_COMPARATOR

sensorio-motor training

Intervention Type: PROCEDURE

guidelines

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.

Group Type: ACTIVE_COMPARATOR

sensorio-motor training

Intervention Type: PROCEDURE

Interventions

sensorio-motor training

Intervention Type: PROCEDURE

Other Intervention Names

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Rinaldo Roberto de Jesus Guirro

PHD Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ariane H M Pletsch, PHD Student

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Rinaldo Roberto Jesus Guirro, PHD

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

Rinaldo Roberto de Jesus Guirro

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

Central Contacts

Ariane H.M Pletsch, PHD student

Role: CONTACT

ariane_mansano@usp.br

+551636020462 ext. Brazil

Rinaldo Roberto Jesus Guirro, PHD

Role: CONTACT

rguirro@fmrp.usp.br

+551636024584 ext. Brazil

Facility Contacts

Rinaldo Jesus Guirro, PHD

Role: primary

rguirro@fmrp.usp.br

+551636024584

Ariane H M Pletsch, PHD student

Role: backup

ariane_mansano@usp.br

+551636020462

References

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.

Reference Type: BACKGROUND

PMID: 15111519 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21444119 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19264569 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21561371 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33508955 (View on PubMed)

Related Links

http://www.fmrp.usp.br

Related Info

Other Identifiers

U1111-1143-3618

Identifier Type: -

Identifier Source: org_study_id