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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Effects oF Resistive Exercise or Proprioceptive Exercise Training on Balance and Superficial Sense of Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03363386
• Other study ID #: Yeditepe U
• Status: Completed
• Phase: N/A
• First received: November 10, 2017
• Last updated: December 5, 2017
• Start date: December 2016
• Est. completion date: March 2017

Study information

• Verified date: December 2017
• Source: Yeditepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Procedure:
• Proprioceptive Exercises
Patients trained for proprioceptive exercises
• Resistive Exercises
Patients trained for resistive exercises
• Aerobic Exercise
Patients were educated with treadmill walking for 30 minutes of each exercise session

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yeditepe University

Outcome

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