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
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
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
NCT ID
NCT03363386
First Posted
November 10, 2017
Last Updated
December 5, 2017
Sponsor
Yeditepe University
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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