Clinical trial NCT03363386: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: aerobic exercise
dynamic balance
functional capacity
HbA1c
proprioceptive exercise training
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 33
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Change in HbA1c level
timeFrame: 6 weeks
measure: Waist and Hip Circumferences
timeFrame: 6 weeks
measure: Six minute walking test
timeFrame: 6 weeks
measure: Dynamic balance assessment
timeFrame: 6 weeks
measure: Vibration Perception Threshold Assessment
timeFrame: 6 weeks
measure: Lower Extremity Muscle Strength
timeFrame: 6 weeks
measure: Proprioception Assesment
timeFrame: 6 weeks
measure: Two Point Discrimination Test
timeFrame: 6 weeks
measure: Change in fasting blood glucose level
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation
name: Guzin Kaya Aytutuldu, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation
name: Feryal Subasi, Professor
role: STUDY_CHAIR
affiliation: Istanbul Pendik Kaynarca Outpatient Policlinic Diabetes Center
name: Gülgün Arslan, MD
role: STUDY_CHAIR
affiliation: Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation
name: Elif Develi, M.Sc.
role: STUDY_CHAIR
References: