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

Effects of Wearable Technology and Smart Mobile Phone Applications Based Exercise Training and 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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Wearable watch training group.; Behavioral: Mobile application training group.; Behavioral: Supervised exercise training group

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 Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Maltepe
    • Istanbul, Maltepe, Turkey, 1464185881
      • Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Wearable watch training group.; 3 orientation session Watch notifies 3/week for exercise
Active Comparator: 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.	Behavioral: 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.
Sham Comparator: Supervised exercise training group; Aerobic exercises Strengthening exercises Stretching exercises supervised by a physical therapist	Behavioral: Supervised exercise training group; 3/week training supervised by a physical therapist

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Adherence Rating Scale (EARS)	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.	5 minutes
Behavioural Regulations in Exercise Questionnaire	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	5 minutes
HDL / LDL	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.	5 minutes
Triglyceride	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.	5 minutes

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Principal Investigator: Eren Timurtas, PT, MSc, Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2018
• Primary Completion (Actual): September 22, 2018
• Study Completion (Anticipated): May 5, 2019

Study Registration Dates

• First Submitted: December 1, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: exercise; self-management; Physical activity; Diabetes Mellitus, Type 2; wearable technology; smart phone; exercise behavior; glycated hemoglobin (HbA1c)
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 09.2017.604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No