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Clinical Trials/NCT03766802
NCT03766802
Unknown
Not Applicable

Effects of Wearable Technology and Smart Mobile Phone Applications Based Exercise Training and Supervised Exercise Training in Patients With Type 2 Diabetes

Marmara University1 site in 1 country102 target enrollmentStarted: February 5, 2018Last updated:

Overview

Phase
Not Applicable
Enrollment
102
Locations
1
Primary Endpoint
Glycated Hemoglobin (HbA1c)

Overview

Brief Summary

The purpose of this study is to estimate the extent to which supported exercise training through wearable technology and mobile application affects glycemic control in comparison to supervised exercise training in patients with Type-2 Diabetes.

Detailed Description

The purpose of this study is to estimate the extent to which supported exercise training through wearable technology and mobile application affects glycemic control in comparison to supervised exercise training in patients with Type-2 Diabetes.

Inclusion Criteria:

  • Age 18-65
  • No other chronic condition
  • No exercise training background Block Randomization according to age and sex.

Confirmatory Outcome

  • Glycated Hemoglobin (HbA1c)

Explanatory outcomes

  • Flexibility
  • Level of Physical Activity - IPaQ (METS) and accelerometer
  • Hamstring / Quad strength - isokinetic
  • Grip strength
  • Respiratory function test - F1, FVC, F25, F75, F100
  • 6MWT
  • Balance - static, dynamic, proprioception, sit-to-stand balance
  • Body Muscle Percentage - bioelectrical impedance analysis

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 18-65 No other chronic condition No exercise training background

Exclusion Criteria

  • Exclusion criteria are a set of predefined condition that is used to identify subjects who will not be included or who will have to withdraw from a research study after being included.

Outcomes

Primary Outcomes

Glycated Hemoglobin (HbA1c)

Time Frame: 5 minutes

It used as a diagnostic test for diabetes and as assessment test for glycemic control in people with diabetes. It comes in unit of percentage identifies how much glucose is carried on a certain amount of blood. We included people who have 6.5% or more which is the cut point for The International Diabetes Federation and the American College of Endocrinology.

Secondary Outcomes

  • Six-Minute Walk Test(6 min)
  • International physical activity questionnaire short form (IPAQ)(7 days)
  • The forced vital capacity(10 minutes)
  • Forced expiratory volume(10 minutes)
  • Assessment of muscle strength with isokinetic device(15 minutes)
  • Accelerometer(7 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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