Clinical trial NCT03390959: Effectiveness of Proprioceptive Training on Plantar Pressure, Balance, Posture and Gait in Individuals With Diabetes Mellitus Type 2
Official title: Effectiveness of Proprioceptive Training on Plantar Pressure, Postural Balance, Posture and Gait in Individuals With Diabetes Mellitus Type 2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Proprioception
Diabetes Mellitus, Type 2
Postural Balance
Gait
Posture
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 14
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: Control Group (CG) and the Trained Group (TG)
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Plantar Pressure
timeFrame: 5 minutes
measure: Balance
timeFrame: 5 minutes
measure: Posture
timeFrame: 1 hour
measure: Gait
timeFrame: 10 minutes
Secondary outcomes:
measure: Plantar Sensitivity
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Maria das Graças Araujo
state: Pernambuco
Study officials:
References: