<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03766802</url>
  </required_header>
  <id_info>
    <org_study_id>09.2017.604</org_study_id>
    <nct_id>NCT03766802</nct_id>
  </id_info>
  <brief_title>Effects of Wearable Technology and Smart Phone Applications Based Exercise Training in Patients With Type 2 Diabetes</brief_title>
  <official_title>Effects of Wearable Technology and Smart Mobile Phone Applications Based Exercise Training and Supervised Exercise Training in Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marmara University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marmara University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to estimate the extent to which supported exercise training&#xD;
      through wearable technology and mobile application affects glycemic control in comparison to&#xD;
      supervised exercise training in patients with Type-2 Diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to estimate the extent to which supported exercise training&#xD;
      through wearable technology and mobile application affects glycemic control in comparison to&#xD;
      supervised exercise training in patients with Type-2 Diabetes.&#xD;
&#xD;
      Inclusion Criteria:&#xD;
&#xD;
        -  Age 18-65&#xD;
&#xD;
        -  No other chronic condition&#xD;
&#xD;
        -  No exercise training background Block Randomization according to age and sex.&#xD;
&#xD;
      Confirmatory Outcome&#xD;
&#xD;
      - Glycated Hemoglobin (HbA1c)&#xD;
&#xD;
      Explanatory outcomes&#xD;
&#xD;
        -  Flexibility&#xD;
&#xD;
        -  Level of Physical Activity - IPaQ (METS) and accelerometer&#xD;
&#xD;
        -  Hamstring / Quad strength - isokinetic&#xD;
&#xD;
        -  Grip strength&#xD;
&#xD;
        -  Respiratory function test - F1, FVC, F25, F75, F100&#xD;
&#xD;
        -  6MWT&#xD;
&#xD;
        -  Balance - static, dynamic, proprioception, sit-to-stand balance&#xD;
&#xD;
        -  Body Muscle Percentage - bioelectrical impedance analysis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 5, 2018</start_date>
  <completion_date type="Anticipated">May 5, 2019</completion_date>
  <primary_completion_date type="Actual">September 22, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Group 1: Wearable watch training group. 3 orientation session Watch notifies 3/week for exercise&#xD;
Benefits of watch:&#xD;
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&#xD;
Benefits of app:&#xD;
Cheaper Trackable and notifiable if patients don't exercise. Group 3: Supervised exercise training in a fitness center for people with DM.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycated Hemoglobin (HbA1c)</measure>
    <time_frame>5 minutes</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Six-Minute Walk Test</measure>
    <time_frame>6 min</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The forced vital capacity</measure>
    <time_frame>10 minutes</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced expiratory volume</measure>
    <time_frame>10 minutes</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of muscle strength with isokinetic device</measure>
    <time_frame>15 minutes</time_frame>
    <description>An assessment of muscle strength is typically performed as part of a patient's objective assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International physical activity questionnaire short form (IPAQ)</measure>
    <time_frame>7 days</time_frame>
    <description>The International Physical Activity Questionnaire (IPAQ) is used as a comparable and standardised self-report measure of habitual physical activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accelerometer</measure>
    <time_frame>7 days</time_frame>
    <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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Exercise Adherence Rating Scale (EARS)</measure>
    <time_frame>5 minutes</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Behavioural Regulations in Exercise Questionnaire</measure>
    <time_frame>5 minutes</time_frame>
    <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</description>
  </other_outcome>
  <other_outcome>
    <measure>HDL / LDL</measure>
    <time_frame>5 minutes</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Triglyceride</measure>
    <time_frame>5 minutes</time_frame>
    <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.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Wearable watch training group.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.&#xD;
Frequency:3/week Duration:12 weeks Dosage:Dose was increased as person is able to tolerate.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mobile application training group.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Aerobic exercises Strengthening exercises Stretching exercises&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supervised exercise training group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Aerobic exercises Strengthening exercises Stretching exercises supervised by a physical therapist</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wearable watch training group.</intervention_name>
    <description>3 orientation session Watch notifies 3/week for exercise</description>
    <arm_group_label>Wearable watch training group.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mobile application training group.</intervention_name>
    <description>3 orientation session App notifies 3/week for exercise&#xD;
Benefits of app:&#xD;
Cheaper Trackable and notifiable if patients don't exercise.</description>
    <arm_group_label>Mobile application training group.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Supervised exercise training group</intervention_name>
    <description>3/week training supervised by a physical therapist</description>
    <arm_group_label>Supervised exercise training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Age 18-65 No other chronic condition No exercise training background&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria are a set of predefined condition that is used to identify subjects&#xD;
             who will not be included or who will have to withdraw from a research study after&#xD;
             being included.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eren Timurtas, PT, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Marmara University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Health Sciences</name>
      <address>
        <city>Istanbul</city>
        <state>Maltepe</state>
        <zip>1464185881</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 1, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes Mellitus, Type 2</keyword>
  <keyword>Physical activity</keyword>
  <keyword>exercise behavior</keyword>
  <keyword>exercise</keyword>
  <keyword>smart phone</keyword>
  <keyword>wearable technology</keyword>
  <keyword>self-management</keyword>
  <keyword>glycated hemoglobin (HbA1c)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is not a plan to make IPD available.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03766802
org study id: 09.2017.604
nct id: NCT03766802
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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
allocation: Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Glycated Hemoglobin (HbA1c)
time frame: 5 minutes
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.
measure: Six-Minute Walk Test
time frame: 6 min
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
measure: The forced vital capacity
time frame: 10 minutes
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.
measure: Forced expiratory volume
time frame: 10 minutes
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.
measure: Assessment of muscle strength with isokinetic device
time frame: 15 minutes
description: An assessment of muscle strength is typically performed as part of a patient's objective assessment.
measure: International physical activity questionnaire short form (IPAQ)
time frame: 7 days
description: The International Physical Activity Questionnaire (IPAQ) is used as a comparable and standardised self-report measure of habitual physical activity.
measure: Accelerometer
time frame: 7 days
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.
measure: Exercise Adherence Rating Scale (EARS)
time frame: 5 minutes
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.
measure: Behavioural Regulations in Exercise Questionnaire
time frame: 5 minutes
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
measure: HDL / LDL
time frame: 5 minutes
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.
measure: Triglyceride
time frame: 5 minutes
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.
arm group label: Wearable watch training group.
arm group type: Active Comparator
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 group label: Mobile application training group.
arm group type: Active Comparator
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 group label: Supervised exercise training group
arm group type: Sham Comparator
description: Aerobic exercises Strengthening exercises Stretching exercises supervised by a physical therapist
intervention type: Behavioral
intervention name: Wearable watch training group.
description: 3 orientation session Watch notifies 3/week for exercise
arm group label: Wearable watch training group.
intervention type: Behavioral
intervention name: Mobile application training group.
description: 3 orientation session App notifies 3/week for exercise
Benefits of app:
Cheaper Trackable and notifiable if patients don't exercise.
arm group label: Mobile application training group.
intervention type: Behavioral
intervention name: Supervised exercise training group
description: 3/week training supervised by a physical therapist
arm group label: Supervised exercise training group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Eren Timurtas, PT, MSc
role: Principal Investigator
affiliation: Marmara University
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No
ipd description: There is not a plan to make IPD available.