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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03363386
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Yeditepe University

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).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Procedure: Proprioceptive Exercises Procedure: Resistive Exercises Procedure: Aerobic Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Effects oF Resistive Exercise or Proprioceptive Exercise Training on Balance and Superficial Sense of Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : December 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


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: Resistive Exercises
Patients trained for resistive exercises

Procedure: Aerobic Exercise
Patients were educated with treadmill walking for 30 minutes of each exercise session




Primary Outcome Measures :
  1. 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

  2. Waist and Hip Circumferences [ Time Frame: 6 weeks ]
    It represents risks for cardiovascular diseases.

  3. Six minute walking test [ Time Frame: 6 weeks ]
    Functional capacity of the patients was evaluated through 6 minute walking test

  4. Dynamic balance assessment [ Time Frame: 6 weeks ]
    Prokin PK 200 was used for dynamic balance assessment

  5. Vibration Perception Threshold Assessment [ Time Frame: 6 weeks ]
    Biothesiometer was used for determining vibration perception threshold

  6. Lower Extremity Muscle Strength [ Time Frame: 6 weeks ]
    Commander myometer was used for muscle strength assessment

  7. Proprioception Assesment [ Time Frame: 6 weeks ]
    Angle reproduction test was used

  8. Two Point Discrimination Test [ Time Frame: 6 weeks ]
    aesthesiometer was used to determine two point discrimination sensation

  9. 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



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363386


Sponsors and Collaborators
Yeditepe University
Investigators
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Principal Investigator: Guzin Kaya Aytutuldu, M.Sc. Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation
Study Chair: Feryal Subasi, Professor 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
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Responsible Party: Yeditepe University
ClinicalTrials.gov Identifier: NCT03363386    
Other Study ID Numbers: Yeditepe U
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yeditepe University:
aerobic exercise
dynamic balance
functional capacity
HbA1c
proprioceptive exercise training
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases