NCT03766802

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2019

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

8 months

First QC Date

December 1, 2018

Last Update Submit

January 30, 2019

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2Physical activityexercise behaviorexercisesmart phonewearable technologyself-managementglycated hemoglobin (HbA1c)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Six-Minute Walk Test

    6 min

  • The forced vital capacity

    10 minutes

  • Forced expiratory volume

    10 minutes

  • Assessment of muscle strength with isokinetic device

    15 minutes

  • International physical activity questionnaire short form (IPAQ)

    7 days

  • +1 more secondary outcomes

Other Outcomes (4)

  • Exercise Adherence Rating Scale (EARS)

    5 minutes

  • Behavioural Regulations in Exercise Questionnaire

    5 minutes

  • HDL / LDL

    5 minutes

  • +1 more other outcomes

Study Arms (3)

Wearable watch training group.

ACTIVE COMPARATOR

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.

Mobile application training group.

ACTIVE COMPARATOR

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.

Supervised exercise training group

SHAM COMPARATOR

Aerobic exercises Strengthening exercises Stretching exercises supervised by a physical therapist

Behavioral: Supervised exercise training group

Interventions

Wearable watch training group.BEHAVIORAL

3 orientation session Watch notifies 3/week for exercise

Wearable watch training group.
Mobile application training group.BEHAVIORAL

3 orientation session App notifies 3/week for exercise Benefits of app: Cheaper Trackable and notifiable if patients don't exercise.

Mobile application training group.
Supervised exercise training groupBEHAVIORAL

3/week training supervised by a physical therapist

Supervised exercise training group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 No other chronic condition No exercise training background

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences

Istanbul, Maltepe, 1464185881, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Eren Timurtas, PT, MSc

    Marmara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2018

First Posted

December 6, 2018

Study Start

February 5, 2018

Primary Completion

September 22, 2018

Study Completion

May 5, 2019

Last Updated

February 1, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations

TU(1)