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

Not Applicable

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT03766802
• Lead Sponsor: Marmara University

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 Timeline

• Study Start: 2018-02-05
• Primary Completion: 2018-09-22
• Study First Submitted: 2018-12-01
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-06
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-02-01
• Study Completion: 2019-05-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Glycated Hemoglobin (HbA1c)	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 Outcome Measures

Name	Time	Method
Six-Minute Walk Test	6 min	The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes
International physical activity questionnaire short form (IPAQ)	7 days	The International Physical Activity Questionnaire (IPAQ) is used as a comparable and standardised self-report measure of habitual physical activity.
The forced vital capacity	10 minutes	The forced vital capacity (FVC) is a measurement of the maximum volume of gas a patient can exhale as forcefully and quickly as possible after a maximal inspiration.Pulmonary function test used to determine forced vital capacity. Breathing multiple times into a spirometry, with regular and maximal effort, through a tube that is connected to a computer. The unit for this test is in volume (L). And it will be analyzed as a continuous variable.
Forced expiratory volume	10 minutes	Forced expiratory volume (FEV) measures how much air a patient can exhale during a forced breath. Pulmonary function test used to determine Forced expiratory volume.The amount of air exhaled is measured during the first (FEV1), second (FEV2), and/or third seconds (FEV3) of the forced breath. The unit for this test is in volume (L). And it will be analyzed as a continuous variable.
Assessment of muscle strength with isokinetic device	15 minutes	An assessment of muscle strength is typically performed as part of a patient's objective assessment.
Accelerometer	7 days	Accelerometer is a device that measures hours of physical activity in a week. The device was placed on the belt of the participants and was collected back after 7 days. Accelerometer collects data on the three-dimensional angles, which explains the direction, frequency, and magnitude of the movement. Total number of hours of physical activity is used to measure whether participants meet the optimal activity level recommended by physical activity guidelines.

Trial Locations

Locations (1)

Faculty of Health Sciences; 🇹🇷 Istanbul, Maltepe, Turkey