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Clinical Trials/NCT03363386
NCT03363386
Completed
N/A

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

Yeditepe University0 sites33 target enrollmentDecember 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Type 2 Diabetes Mellitus
Sponsor
Yeditepe University
Enrollment
33
Primary Endpoint
Dynamic balance assessment
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
March 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Dynamic balance assessment

Time Frame: 6 weeks

Prokin PK 200 was used for dynamic balance assessment

Change in fasting blood glucose level

Time Frame: 6 weeks

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

Six minute walking test

Time Frame: 6 weeks

Functional capacity of the patients was evaluated through 6 minute walking test

Change in HbA1c level

Time Frame: 6 weeks

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

Waist and Hip Circumferences

Time Frame: 6 weeks

It represents risks for cardiovascular diseases.

Lower Extremity Muscle Strength

Time Frame: 6 weeks

Commander myometer was used for muscle strength assessment

Proprioception Assesment

Time Frame: 6 weeks

Angle reproduction test was used

Two Point Discrimination Test

Time Frame: 6 weeks

aesthesiometer was used to determine two point discrimination sensation

Vibration Perception Threshold Assessment

Time Frame: 6 weeks

Biothesiometer was used for determining vibration perception threshold

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