Effectiveness of Proprioceptive Training on Plantar Pressure, Balance, Posture and Gait in Individuals With Diabetes Mellitus Type 2

NCT ID: NCT03390959

Last Updated: 2018-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-10
• Study Completion Date: 2018-03-30

Brief Summary

Introduction: Diabetes mellitus (DM) can be considered as one of the most important chronic diseases in the public health system, presenting a high cost for health services. Along with the increase in diagnosed cases of DM, there is a simultaneous increase in DM-related manifestations, such as peripheral diabetic neuropathy, diabetic foot ulcers and amputations. Decreased plantar sensitivity caused by microvascular complications, reduced sensation of vibration and loss of pressure sensitivity may be associated with recurrent falls due to reduced proprioceptive feedback. Although much is known about the beneficial results of physical exercise on glucose metabolism and insulin action, there are still few studies that evaluate the effects of different types of physical exercise, especially proprioceptive training, on plantar pressure, balance and posture of individuals.

Objective: The present study aims to evaluate the efficacy of proprioceptive training on plantar pressure, postural balance and posture in adults with Type 2 Diabetes Mellitus.

Methods: This study is a randomized, double blind, controlled clinical trial (evaluator and statistician) with individuals of both sexes, with type 2 diabetes mellitus diagnosed for at least 3 years, over 45 years of age, that can walk without assistance or supervision of others. Two groups will be formed, the Control Group (CG) and the Trained Group (TG), and the ideal "n" will be calculated in a pilot study.

Conditions

Diabetes Mellitus, Type 2

Study Design

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

Study Groups

Proprioceptive Training

The group participates in proprioceptive training that promotes sensory integration.

Group Type: EXPERIMENTAL

Proprioceptive Training

Intervention Type: OTHER

Individuals in the Trained Group will perform the training twice a week for 45 minutes and perform for a period of 12 weeks.

The training is divided into a pre-training phase where general hip dissociation exercises and simple stretching of the hip flexor and extensor muscle groups, knee, foot and paravertebral are performed.

The second phase is the proprioceptive training, where it will involve training of balance, sensitivity and proprioception, being used a circuit composed of 15 stations, whose time of stay in each station is 2 minutes.

And finally the third stage are relaxation exercises, performed with breathing exercises associated with slow active movements of the joints.

Control Group

The group continues in their daily lives with phone monitoring.

Group Type: OTHER

Control Group

Intervention Type: OTHER

Will not be submitted to any physical intervention. It continues in your daily life with only phone monitoring.

Interventions

Proprioceptive Training

Individuals in the Trained Group will perform the training twice a week for 45 minutes and perform for a period of 12 weeks.

The training is divided into a pre-training phase where general hip dissociation exercises and simple stretching of the hip flexor and extensor muscle groups, knee, foot and paravertebral are performed.

The second phase is the proprioceptive training, where it will involve training of balance, sensitivity and proprioception, being used a circuit composed of 15 stations, whose time of stay in each station is 2 minutes.

And finally the third stage are relaxation exercises, performed with breathing exercises associated with slow active movements of the joints.

Intervention Type: OTHER

Control Group

Will not be submitted to any physical intervention. It continues in your daily life with only phone monitoring.

Intervention Type: OTHER

Other Intervention Names

Experimental

Eligibility Criteria

Inclusion Criteria

• individuals with type 2 diabetes mellitus, diagnosed for at least 3 years
• both genders
• aged 45 years or over
• able to wander without assistance or supervision from others
• absence of macroangiopathy
• no history of neurological, muscular or rheumatic diseases for the etiology of diabetes
• agree to participate in the study, signing the Free and Informed Consent Term (TCLE) pursuant to Resolution 466/12 of the National Health Council

Exclusion Criteria

• presence of uncontrolled hypertension (systolic ≥ 200 mmHg and / or diastolic ≤100 mmHg);
• presence of a rheumatic condition that makes it impossible to perform the movements performed in the evaluation and in the therapeutic intervention;
• lack of more than 15% to the proprioceptive training program;
• individuals who perform some physical activity
• dependence on alcohol and illicit drugs

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kelly Antunes e Silva Oliveira

OTHER

Sponsor Role: lead

Responsible Party

Kelly Antunes e Silva Oliveira

Bachelor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Maria das Graças Araujo

Recife, Pernambuco, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Maria das Graças Araujo, PhD

Role: CONTACT

mgrodriguesaraujo@hotmail.com

+558121268939

Kelly Antunes e Silva Oliveira, bachelor

Role: CONTACT

kelly.antunes@gmail.com

+5583998346441

Other Identifiers

Feedback N.2.052.913

Identifier Type: OTHER

Identifier Source: secondary_id

Proprioceptive DM2

Identifier Type: -

Identifier Source: org_study_id