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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Wearable watch training group.
* Behavioral: Mobile application training group.
* Behavioral: Supervised exercise training group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1: Wearable watch training group. 3 orientation session Watch notifies 3/week for exercise Benefits of watch: BP and movement sensors allow to validate if the patient has exercised. Videos for exercises. Trackable and notifiable if patients don't exercise. Group 2: Mobile application training group. 3 orientation session App notifies 3/week for exercise Benefits of app: Cheaper Trackable and notifiable if patients don't exercise. Group 3: Supervised exercise training in a fitness center for people with DM.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wearable watch training group.<br>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. | Behavioral: Wearable watch training group.<br>* 3 orientation session Watch notifies 3/week for exercise<br>|
| Active Comparator: Mobile application training group.<br>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. | Behavioral: Mobile application training group.<br>* 3 orientation session App notifies 3/week for exercise Benefits of app: Cheaper Trackable and notifiable if patients don't exercise.<br>|
| Sham Comparator: Supervised exercise training group<br>Aerobic exercises Strengthening exercises Stretching exercises supervised by a physical therapist | Behavioral: Supervised exercise training group<br>* 3/week training supervised by a physical therapist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated Hemoglobin (HbA1c) | 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. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-Minute Walk Test | The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes | 6 min | 
| The forced vital capacity | 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. | 10 minutes | 
| Forced expiratory volume | 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. | 10 minutes | 
| Assessment of muscle strength with isokinetic device | An assessment of muscle strength is typically performed as part of a patient's objective assessment. | 15 minutes | 
| International physical activity questionnaire short form (IPAQ) | The International Physical Activity Questionnaire (IPAQ) is used as a comparable and standardised self-report measure of habitual physical activity. | 7 days | 
| Accelerometer | 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. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2, Physical activity, exercise behavior, exercise, smart phone, wearable technology, self-management, glycated hemoglobin (HbA1c)