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

NCT03363386 | Completed

• 1 other identifier: Yeditepe U
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Type 2 Diabetes Mellitus

Keywords

aerobic exercise; dynamic balance; functional capacity; HbA1c; proprioceptive exercise training

Outcome Measures

Primary Outcomes (9)

• 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

• Waist and Hip Circumferences

  It represents risks for cardiovascular diseases.

  6 weeks

• Six minute walking test

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

  6 weeks

• Dynamic balance assessment

  Prokin PK 200 was used for dynamic balance assessment

  6 weeks

• Vibration Perception Threshold Assessment

  Biothesiometer was used for determining vibration perception threshold

  6 weeks

• Lower Extremity Muscle Strength

  Commander myometer was used for muscle strength assessment

  6 weeks

• Proprioception Assesment

  Angle reproduction test was used

  6 weeks

• Two Point Discrimination Test

  aesthesiometer was used to determine two point discrimination sensation

  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

  6 weeks

Study Arms (2)

Proprioceptive Exercise Group (PG)

EXPERIMENTAL

Aerobic Exercise Proprioceptive Exercises

Procedure: Proprioceptive Exercises; Procedure: Aerobic Exercise

Resistive Exercise Group (RG)

ACTIVE COMPARATOR

Aerobic Exercise Resistive Exercises

Procedure: Resistive Exercises; Procedure: Aerobic Exercise

Interventions

Proprioceptive Exercises PROCEDURE

Patients trained for proprioceptive exercises

Proprioceptive Exercise Group (PG)

Resistive Exercises PROCEDURE

Patients trained for resistive exercises

Resistive Exercise Group (RG)

Aerobic Exercise PROCEDURE

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

Proprioceptive Exercise Group (PG); Resistive Exercise Group (RG)

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yeditepe University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Guzin Kaya Aytutuldu, M.Sc.

  Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Feryal Subasi, Professor

  Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation

  STUDY CHAIR

• Gülgün Arslan, MD

  Istanbul Pendik Kaynarca Outpatient Policlinic Diabetes Center

  STUDY CHAIR

• Elif Develi, M.Sc.

  Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: December 6, 2017
• Study Start: December 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2017
• Last Updated: December 6, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share