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

NCT ID: NCT03363386

Last Updated: 2017-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-03-31

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Proprioceptive Exercise Group (PG)

Aerobic Exercise Proprioceptive Exercises

Group Type: EXPERIMENTAL

Proprioceptive Exercises

Intervention Type: PROCEDURE

Patients trained for proprioceptive exercises

Aerobic Exercise

Intervention Type: PROCEDURE

Patients were educated with treadmill walking for 30 minutes of each exercise session

Resistive Exercise Group (RG)

Aerobic Exercise Resistive Exercises

Group Type: ACTIVE_COMPARATOR

Resistive Exercises

Intervention Type: PROCEDURE

Patients trained for resistive exercises

Aerobic Exercise

Intervention Type: PROCEDURE

Patients were educated with treadmill walking for 30 minutes of each exercise session

Interventions

Proprioceptive Exercises

Patients trained for proprioceptive exercises

Intervention Type: PROCEDURE

Resistive Exercises

Patients trained for resistive exercises

Intervention Type: PROCEDURE

Aerobic Exercise

Patients were educated with treadmill walking for 30 minutes of each exercise session

Intervention Type: PROCEDURE

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
• Severe retinopathy, nephropathy
• Thyroid Dysfunctions (hyperthyroidism, hypothyroidism).

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yeditepe University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guzin Kaya Aytutuldu, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation

Feryal Subasi, Professor

Role: STUDY_CHAIR

Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation

Gülgün Arslan, MD

Role: STUDY_CHAIR

Istanbul Pendik Kaynarca Outpatient Policlinic Diabetes Center

Elif Develi, M.Sc.

Role: STUDY_CHAIR

Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation

Other Identifiers

Yeditepe U

Identifier Type: -

Identifier Source: org_study_id