Type 2 Diabetes MellitusNCT03363386
Effects Of Resistive Exercise or Proprioceptive Exercise Training Among Patients With Type 2 Diabetes Mellitus
A study testing Proprioceptive Exercises, Resistive Exercises and Aerobic Exercise in people with Type 2 Diabetes Mellitus, run by Yeditepe University.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Proprioceptive Exercises, Resistive Exercises and Aerobic Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Unstable cardiac condition
- Uncontrolled Diabetes Mellitus
- Uncontrolled Hypertension
- Symptomatic Heart Failure, unstable angina
- Peripheral Arterial Occlusive Disease
- Diabetic foot ulcers
Show all 12Show fewer
- 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).
About this study
Official title: 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).
Read the 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
- Being tested
- Proprioceptive Exercises, Resistive Exercises, Aerobic Exercise
- Keywords
- aerobic exercise, dynamic balance, functional capacity, HbA1c, proprioceptive exercise training
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive ExercisesProcedure or surgery
Patients trained for proprioceptive exercises
Resistive ExercisesProcedure or surgery
Patients trained for resistive exercises
Aerobic ExerciseProcedure or surgery
Patients were educated with treadmill walking for 30 minutes of each exercise session
| Study group | Role | What they receive |
|---|---|---|
| Proprioceptive Exercise Group (PG) | Experimental | Aerobic Exercise Proprioceptive Exercises Receives: Procedure: Proprioceptive Exercises; Procedure: Aerobic Exercise |
| Resistive Exercise Group (RG) | Active comparator | Aerobic Exercise Resistive Exercises Receives: Procedure: Resistive Exercises; Procedure: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Waist and Hip Circumferences
It represents risks for cardiovascular diseases.
Measured: 6 weeks
Six minute walking test
Functional capacity of the patients was evaluated through 6 minute walking test
Measured: 6 weeks
Dynamic balance assessment
Prokin PK 200 was used for dynamic balance assessment
Measured: 6 weeks
Vibration Perception Threshold Assessment
Biothesiometer was used for determining vibration perception threshold
Measured: 6 weeks
Lower Extremity Muscle Strength
Commander myometer was used for muscle strength assessment
Measured: 6 weeks
Proprioception Assesment
Angle reproduction test was used
Measured: 6 weeks
Two Point Discrimination Test
aesthesiometer was used to determine two point discrimination sensation
Measured: 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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study startDec 2016
- Primary completionJan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guzin Kaya Aytutuldu, M.Sc., Principal investigator, Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and RehabilitationFeryal Subasi, Professor, Study chair, Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and RehabilitationGülgün Arslan, MD, Study chair, Istanbul Pendik Kaynarca Outpatient Policlinic Diabetes CenterElif Develi, M.Sc., Study chair, Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363386
- Sponsor's protocol ID
- Yeditepe U
- Status last verified
- Dec 2017
- First submitted
- 10 Nov 2017
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects oF Resistive Exercise or Proprioceptive Exercise Training on Balance and Superficial Sense of Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03363386
- Acronym / sponsor ID
- Yeditepe U
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- aerobic exercise, dynamic balance, functional capacity, HbA1c, proprioceptive exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive Exercise Group (PG) | Experimental | Procedure: Proprioceptive Exercises, Procedure: Aerobic ExerciseAerobic Exercise Proprioceptive Exercises |
| Resistive Exercise Group (RG) | Active comparator | Procedure: Resistive Exercises, Procedure: Aerobic ExerciseAerobic Exercise Resistive Exercises |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- Unstable cardiac condition
- Uncontrolled Diabetes Mellitus
- Uncontrolled Hypertension
- Symptomatic Heart Failure, unstable angina
- Peripheral Arterial Occlusive Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprioceptive ExercisesPatients trained for proprioceptive exercises | Procedure or surgery | Proprioceptive Exercise Group (PG) |
| Resistive ExercisesPatients trained for resistive exercises | Procedure or surgery | Resistive Exercise Group (RG) |
| Aerobic ExercisePatients were educated with treadmill walking for 30 minutes of each exercise session | Procedure or surgery | Proprioceptive Exercise Group (PG), Resistive Exercise Group (RG) |
Primary outcome
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
Waist and Hip Circumferences
Time frame: 6 weeks
It represents risks for cardiovascular diseases.
Six minute walking test
Time frame: 6 weeks
Functional capacity of the patients was evaluated through 6 minute walking test
Dynamic balance assessment
Time frame: 6 weeks
Prokin PK 200 was used for dynamic balance assessment
Vibration Perception Threshold Assessment
Time frame: 6 weeks
Biothesiometer was used for determining vibration perception threshold
Lower Extremity Muscle Strength
Time frame: 6 weeks
Commander myometer was used for muscle strength assessment
Proprioception Assesment
Time frame: 6 weeks
Angle reproduction test was used
Two Point Discrimination Test
Time frame: 6 weeks
aesthesiometer was used to determine two point discrimination sensation
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guzin Kaya Aytutuldu, M.Sc. principal investigator
Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation
Feryal Subasi, Professor study chair
Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation
Gülgün Arslan, MD study chair
Istanbul Pendik Kaynarca Outpatient Policlinic Diabetes Center
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive Exercises, Resistive Exercises and Aerobic Exercise in people with Type 2 Diabetes Mellitus, run by Yeditepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c level (time frame: 6 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017.