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Completed

NCT Number: NCT03363386

Effects Of Resistive Exercise or Proprioceptive Exercise Training Among 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).

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Proprioceptive Exercises

Procedure

Patients trained for proprioceptive exercises

Resistive Exercises

Procedure

Patients trained for resistive exercises

Aerobic Exercise

Procedure

Patients were educated with treadmill walking for 30 minutes of each exercise session

Primary outcomes

  1. 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

  2. Waist and Hip Circumferences

    Time frame: 6 weeks

    It represents risks for cardiovascular diseases.

  3. Six minute walking test

    Time frame: 6 weeks

    Functional capacity of the patients was evaluated through 6 minute walking test

  4. Dynamic balance assessment

    Time frame: 6 weeks

    Prokin PK 200 was used for dynamic balance assessment

  5. Vibration Perception Threshold Assessment

    Time frame: 6 weeks

    Biothesiometer was used for determining vibration perception threshold

  6. Lower Extremity Muscle Strength

    Time frame: 6 weeks

    Commander myometer was used for muscle strength assessment

  7. Proprioception Assesment

    Time frame: 6 weeks

    Angle reproduction test was used

  8. Two Point Discrimination Test

    Time frame: 6 weeks

    aesthesiometer was used to determine two point discrimination sensation

  9. 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

Sponsors and collaborators

Lead sponsor

Yeditepe University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 6, 2017
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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