Effects Of Resistive Exercise or Proprioceptive Exercise Training Among Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The aim of the study is to investigate proprioceptive exercises training combined with aerobic exercises and resistive exercises training combined with aerobic exercises on dynamic balance and superficial sense. The patients were randomly divided into Proprioceptive Exercise Training Group (PG) (n=15) and Resistive Exercise Training Group (RG) (n=15). All subjects were included exercise education program and both groups had trained aerobic exercise program for walking on treadmill (2times/wk. 6 week duration).

Detailed Description
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The aim of the study is to investigate proprioceptive exercises training combined with aerobic exercises and resistive exercises training combined with aerobic exercises on dynamic balance and superficial sense. The study included 30 volunteers with Type 2 Diabetes Mellitus(T2DM) who were referred to Fitness Center Arif Nihat Asya Kültür Merkezi Istanbul, Turkey by a medical doctor between December 2016- March 2017 and got diagnosed and followed up at least 6 month before. Glycemic control of all the participants were assessed according to fasting blood glucose and glycolated hemoglobin (HbA1c). Waist and hip circumference was recorded in centimeters. Six minute walking test (6MWT) was used to determine functional capacity of participants. We evaluated the dynamic balance of patients by Prokin PK200, Italy. Five parameters were obtained from Prokin as; Perimeter Length (PL), Area gap percentade (AGP) Medium Speed (MS), Anteroposterior equilibrium (AP) and Mediolateral equilibrium (ML). Proprioception assessment was done with angle reproduction test in direction of dorsiflexion and plantar flexion and deviations were recorded. Superficial sense was assessed with two point discrimination test and vibration threshold was evaluated by biothesiometer. Lower extremity muscles strength were assessed with handheld dynamometer (PowerTrack II commander, JTech Medical, Midvale, UT). The patients were randomly divided into Proprioceptive Exercise Training Group (PG) and Resistive Exercise Training Group (RG). All subjects were included exercise education program and both groups had trained aerobic exercise program for walking on treadmill (2times/wk. 6 week duration). The proprioceptive exercise program was applied in PG and the resistive exercise program was applied in RG twice a week and for duration 6 week.

Official Title
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Effects oF Resistive Exercise or Proprioceptive Exercise Training on Balance and Superficial Sense of Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Procedure: Proprioceptive Exercises
* Procedure: Resistive Exercises
* Procedure: Aerobic Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participating to the study in a voluntary basis Patients with 30-60 years old Getting diagnosed with Type 2 Diabetes Mellitus (DM) at least 6 months. Exclusion Criteria: Unstable cardiac condition Uncontrolled Diabetes Mellitus Uncontrolled Hypertension Symptomatic Heart Failure, unstable angina Peripheral Arterial Occlusive Disease Diabetic foot ulcers Part/total foot amputation Myocardial infarction within 3 months prior to study Coronary Artery Bypass within 3 months prior to study Cerebrovascular ischemia/stroke (including TIA) within 3 months of study Severe retinopathy, nephropathy Thyroid Dysfunctions (hyperthyroidism, hypothyroidism).

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The sample of study consists of patients with Type 2 Diabetes Mellitus (DM) got diagnosed at least 6 months and who referred to Fitness Center in Pendik Arif Nihat Asya Kültür Merkezi Istanbul Turkey by a medical doctor between December 2016- March 2017. The study included in 30 patients (24F, 6M) with T2DM. The patients who met inclusion criteria are divided into two groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proprioceptive Exercise Group (PG)<br>Aerobic Exercise Proprioceptive Exercises | Procedure: Proprioceptive Exercises<br>* Patients trained for proprioceptive exercises<br>Procedure: Aerobic Exercise<br>* Patients were educated with treadmill walking for 30 minutes of each exercise session<br>|
| Active Comparator: Resistive Exercise Group (RG)<br>Aerobic Exercise Resistive Exercises | Procedure: Resistive Exercises<br>* Patients trained for resistive exercises<br>Procedure: Aerobic Exercise<br>* Patients were educated with treadmill walking for 30 minutes of each exercise session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c level | It was evaluated for metabolic control with patient's routine controls in their clinics follow-up. At the end of the study, this metabolic variable was evaluated again in order to observe changes | 6 weeks | 
| Waist and Hip Circumferences | It represents risks for cardiovascular diseases. | 6 weeks | 
| Six minute walking test | Functional capacity of the patients was evaluated through 6 minute walking test | 6 weeks | 
| Dynamic balance assessment | Prokin PK 200 was used for dynamic balance assessment | 6 weeks | 
| Vibration Perception Threshold Assessment | Biothesiometer was used for determining vibration perception threshold | 6 weeks | 
| Lower Extremity Muscle Strength | Commander myometer was used for muscle strength assessment | 6 weeks | 
| Proprioception Assesment | Angle reproduction test was used | 6 weeks | 
| Two Point Discrimination Test | aesthesiometer was used to determine two point discrimination sensation | 6 weeks | 
| Change in fasting blood glucose level | It was evaluated for metabolic control with patient's routine controls in their clinics follow-up. At the end of the study, this metabolic variable was evaluated again in order to observe changes | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aerobic exercise, dynamic balance, functional capacity, HbA1c, proprioceptive exercise training