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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Wearable watch training group.
Mobile application training group.
Supervised exercise training group
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Physical activity, exercise behavior, exercise, smart phone, wearable technology, self-management, glycated hemoglobin (HbA1c)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Wearable watch training group.

Mobile application training group.

Supervised exercise training group

Arm Description

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.

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.

Aerobic exercises Strengthening exercises Stretching exercises supervised by a physical therapist

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 1, 2018
Last Updated
January 30, 2019
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT03766802
Brief Title
Effects of Wearable Technology and Smart Phone Applications Based Exercise Training in Patients With Type 2 Diabetes
Official Title
Effects of Wearable Technology and Smart Mobile Phone Applications Based Exercise Training and Supervised Exercise Training in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 5, 2018 (Actual)
Primary Completion Date
September 22, 2018 (Actual)
Study Completion Date
May 5, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus, Type 2, Physical activity, exercise behavior, exercise, smart phone, wearable technology, self-management, glycated hemoglobin (HbA1c)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wearable watch training group.
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Mobile application training group.
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Supervised exercise training group
Arm Type
Sham Comparator
Arm Description
Aerobic exercises Strengthening exercises Stretching exercises supervised by a physical therapist
Intervention Type
Behavioral
Intervention Name(s)
Wearable watch training group.
Intervention Description
3 orientation session Watch notifies 3/week for exercise
Intervention Type
Behavioral
Intervention Name(s)
Mobile application training group.
Intervention Description
3 orientation session App notifies 3/week for exercise Benefits of app: Cheaper Trackable and notifiable if patients don't exercise.
Intervention Type
Behavioral
Intervention Name(s)
Supervised exercise training group
Intervention Description
3/week training supervised by a physical therapist
Primary Outcome Measure Information:
Title
Glycated Hemoglobin (HbA1c)
Description
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.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Six-Minute Walk Test
Description
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes
Time Frame
6 min
Title
The forced vital capacity
Description
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.
Time Frame
10 minutes
Title
Forced expiratory volume
Description
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.
Time Frame
10 minutes
Title
Assessment of muscle strength with isokinetic device
Description
An assessment of muscle strength is typically performed as part of a patient's objective assessment.
Time Frame
15 minutes
Title
International physical activity questionnaire short form (IPAQ)
Description
The International Physical Activity Questionnaire (IPAQ) is used as a comparable and standardised self-report measure of habitual physical activity.
Time Frame
7 days
Title
Accelerometer
Description
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.
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Exercise Adherence Rating Scale (EARS)
Description
The EARS enables the measurement of adherence to prescribed home exercise. This may facilitate the evaluation of interventions promoting self-management for both the prevention and treatment of chronic conditions.
Time Frame
5 minutes
Title
Behavioural Regulations in Exercise Questionnaire
Description
The Behavioural Regulation In Exercise Questionnaire (BREQ) and its subsequent modifications have become the most widely used measures of the continuum of behavioural regulation in exercise psychology research
Time Frame
5 minutes
Title
HDL / LDL
Description
The main goal is to lower LDL-cholesterol and increase HDL-cholesterol. Therefore, HDL and LDL were measured before and after the intervention to identify whether our program had an effect on the cholesterol level. The unit is mmol/L and it comes as a continuous variable.
Time Frame
5 minutes
Title
Triglyceride
Description
Triglycerides are a type of fat (lipid) found in people' blood. It was also measured to estimate the extent to which our intervention had effect on the blood-fat level. The unit is mmol/L and it comes as a continuous variable.
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eren Timurtas, PT, MSc
Organizational Affiliation
Marmara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Health Sciences
City
Istanbul
State/Province
Maltepe
ZIP/Postal Code
1464185881
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.

Learn more about this trial

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

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