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

Marmara University

Status: Unknown

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Supervised exercise training group; Behavioral: Mobile application training group.; Behavioral: Wearable watch training group.

Study type: Interventional

Funder types: Other

Identifiers

NCT03766802

09.2017.604

Details and patient eligibility

About

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.

Full 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

Enrollment: 102 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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102 participants in 3 patient groups

Wearable watch training group.

Active Comparator group

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.

Treatment:

Behavioral: Wearable watch training group.

Mobile application training group.

Active Comparator group

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.

Treatment:

Behavioral: Mobile application training group.

Supervised exercise training group

Sham Comparator group

Description:

Aerobic exercises Strengthening exercises Stretching exercises supervised by a physical therapist

Treatment:

Behavioral: Supervised exercise training group