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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03766802
• Other study ID #: 09.2017.604
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 5, 2018
• Est. completion date: May 5, 2019

Study information

• Verified date: January 2019
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: May 5, 2019
• Est. primary completion date: September 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Wearable watch training group.
3 orientation session Watch notifies 3/week for exercise
• 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.
• Supervised exercise training group
3/week training supervised by a physical therapist

Locations

Country	Name	City	State
Turkey	Faculty of Health Sciences	Istanbul	Maltepe

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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