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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Proprioceptive Exercises
Resistive Exercises
Aerobic Exercise
Sponsored by
Yeditepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring aerobic exercise, dynamic balance, functional capacity, HbA1c, proprioceptive exercise training

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Proprioceptive Exercise Group (PG)

    Resistive Exercise Group (RG)

    Arm Description

    Aerobic Exercise Proprioceptive Exercises

    Aerobic Exercise Resistive Exercises

    Outcomes

    Primary Outcome Measures

    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
    Waist and Hip Circumferences
    It represents risks for cardiovascular diseases.
    Six minute walking test
    Functional capacity of the patients was evaluated through 6 minute walking test
    Dynamic balance assessment
    Prokin PK 200 was used for dynamic balance assessment
    Vibration Perception Threshold Assessment
    Biothesiometer was used for determining vibration perception threshold
    Lower Extremity Muscle Strength
    Commander myometer was used for muscle strength assessment
    Proprioception Assesment
    Angle reproduction test was used
    Two Point Discrimination Test
    aesthesiometer was used to determine two point discrimination sensation
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    November 10, 2017
    Last Updated
    December 5, 2017
    Sponsor
    Yeditepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03363386
    Brief Title
    Effects Of Resistive Exercise or Proprioceptive Exercise Training Among Patients With Type 2 Diabetes Mellitus
    Official Title
    Effects oF Resistive Exercise or Proprioceptive Exercise Training on Balance and Superficial Sense of Patients With Type 2 Diabetes Mellitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2016 (Actual)
    Primary Completion Date
    January 2017 (Actual)
    Study Completion Date
    March 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yeditepe University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus
    Keywords
    aerobic exercise, dynamic balance, functional capacity, HbA1c, proprioceptive exercise training

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Proprioceptive Exercise Group (PG)
    Arm Type
    Experimental
    Arm Description
    Aerobic Exercise Proprioceptive Exercises
    Arm Title
    Resistive Exercise Group (RG)
    Arm Type
    Active Comparator
    Arm Description
    Aerobic Exercise Resistive Exercises
    Intervention Type
    Procedure
    Intervention Name(s)
    Proprioceptive Exercises
    Intervention Description
    Patients trained for proprioceptive exercises
    Intervention Type
    Procedure
    Intervention Name(s)
    Resistive Exercises
    Intervention Description
    Patients trained for resistive exercises
    Intervention Type
    Procedure
    Intervention Name(s)
    Aerobic Exercise
    Intervention Description
    Patients were educated with treadmill walking for 30 minutes of each exercise session
    Primary Outcome Measure Information:
    Title
    Change in HbA1c level
    Description
    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
    Time Frame
    6 weeks
    Title
    Waist and Hip Circumferences
    Description
    It represents risks for cardiovascular diseases.
    Time Frame
    6 weeks
    Title
    Six minute walking test
    Description
    Functional capacity of the patients was evaluated through 6 minute walking test
    Time Frame
    6 weeks
    Title
    Dynamic balance assessment
    Description
    Prokin PK 200 was used for dynamic balance assessment
    Time Frame
    6 weeks
    Title
    Vibration Perception Threshold Assessment
    Description
    Biothesiometer was used for determining vibration perception threshold
    Time Frame
    6 weeks
    Title
    Lower Extremity Muscle Strength
    Description
    Commander myometer was used for muscle strength assessment
    Time Frame
    6 weeks
    Title
    Proprioception Assesment
    Description
    Angle reproduction test was used
    Time Frame
    6 weeks
    Title
    Two Point Discrimination Test
    Description
    aesthesiometer was used to determine two point discrimination sensation
    Time Frame
    6 weeks
    Title
    Change in fasting blood glucose level
    Description
    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
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guzin Kaya Aytutuldu, M.Sc.
    Organizational Affiliation
    Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Feryal Subasi, Professor
    Organizational Affiliation
    Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Gülgün Arslan, MD
    Organizational Affiliation
    Istanbul Pendik Kaynarca Outpatient Policlinic Diabetes Center
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Elif Develi, M.Sc.
    Organizational Affiliation
    Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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