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

Not Applicable
Conditions
Diabetes Mellitus, Type 2
Interventions
Behavioral: Mobile application training group.
Behavioral: Supervised exercise training group
Behavioral: Wearable watch training group.
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

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
Arm && Interventions
GroupInterventionDescription
Mobile application training group.Mobile application training group.Aerobic exercises Strengthening exercises Stretching exercises Balance exercises Form:intervention is trackable and notifiable if patients don't exercise with smartphone Dose was increased as person is able to tolerate. Frequency:3/week Duration:12 weeks Dosage:Dose was increased as person is able to tolerate.
Supervised exercise training groupSupervised exercise training groupAerobic exercises Strengthening exercises Stretching exercises supervised by a physical therapist
Wearable watch training group.Wearable watch training group.Aerobic exercises Strengthening exercises Stretching exercises Balance exercises Dose was increased as person is able to tolerate. Form:intervention is trackable and notifiable if patients don't exercise with smartwatch. Frequency:3/week Duration:12 weeks Dosage:Dose was increased as person is able to tolerate.
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Six-Minute Walk Test6 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 capacity10 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 volume10 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 device15 minutes

An assessment of muscle strength is typically performed as part of a patient's objective assessment.

Accelerometer7 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

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