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

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

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).

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Procedure: Proprioceptive Exercises; Procedure: Aerobic Exercise; Procedure: Resistive Exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yeditepe University
• Investigators: Principal Investigator: Guzin Kaya Aytutuldu, M.Sc., Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation; Study Chair: Gülgün Arslan, MD, Istanbul Pendik Kaynarca Outpatient Policlinic Diabetes Center; Study Chair: Elif Develi, M.Sc., Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: November 10, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Actual): December 6, 2017
• Last Update Submitted That Met QC Criteria: December 5, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: HbA1c; aerobic exercise; functional capacity; dynamic balance; proprioceptive exercise training
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Yeditepe U

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No