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

NCT ID: NCT03766802

Last Updated: 2019-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-05

Study Completion Date

2019-05-05

Brief Summary

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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

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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

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Wearable watch training group.

Intervention Type BEHAVIORAL

3 orientation session Watch notifies 3/week for exercise

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.

Group Type ACTIVE_COMPARATOR

Mobile application training group.

Intervention Type BEHAVIORAL

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

Aerobic exercises Strengthening exercises Stretching exercises supervised by a physical therapist

Group Type SHAM_COMPARATOR

Supervised exercise training group

Intervention Type BEHAVIORAL

3/week training supervised by a physical therapist

Interventions

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Wearable watch training group.

3 orientation session Watch notifies 3/week for exercise

Intervention Type 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.

Intervention Type BEHAVIORAL

Supervised exercise training group

3/week training supervised by a physical therapist

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Age 18-65 No other chronic condition No exercise training background
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eren Timurtas, PT, MSc

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Locations

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Faculty of Health Sciences

Istanbul, Maltepe, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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09.2017.604

Identifier Type: -

Identifier Source: org_study_id

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