Clinical trial NCT03766802: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Physical activity
exercise behavior
exercise
smart phone
wearable technology
self-management
glycated hemoglobin (HbA1c)
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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

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.

Primary outcomes:
measure: Glycated Hemoglobin (HbA1c)
timeFrame: 5 minutes
Secondary outcomes:
measure: Six-Minute Walk Test
timeFrame: 6 min
measure: The forced vital capacity
timeFrame: 10 minutes
measure: Forced expiratory volume
timeFrame: 10 minutes
measure: Assessment of muscle strength with isokinetic device
timeFrame: 15 minutes
measure: International physical activity questionnaire short form (IPAQ)
timeFrame: 7 days
measure: Accelerometer
timeFrame: 7 days
Other outcomes:
measure: Exercise Adherence Rating Scale (EARS)
timeFrame: 5 minutes
measure: Behavioural Regulations in Exercise Questionnaire
timeFrame: 5 minutes
measure: HDL / LDL
timeFrame: 5 minutes
measure: Triglyceride
timeFrame: 5 minutes
Locations:
city: Istanbul
country: Turkey
facility: Faculty of Health Sciences
state: Maltepe
Study officials:
affiliation: Marmara University
name: Eren Timurtas, PT, MSc
role: PRINCIPAL_INVESTIGATOR
References: