Diabetes Mellitus, Type 2NCT03766802
Effects of Wearable Technology and Smart Phone Applications Based Exercise Training in Patients With Type 2 Diabetes
A study testing Wearable watch training group., Mobile application training group. and Supervised exercise training group in people with Diabetes Mellitus, Type 2, run by Marmara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Wearable watch training group., Mobile application training group. and Supervised exercise training group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2018to 5 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 No other chronic condition No exercise training background
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Sciences
Istanbul, Maltepe, 1464185881
About this study
Official title: Effects of Wearable Technology and Smart Mobile Phone Applications Based Exercise Training and Supervised Exercise Training in Patients With Type 2 Diabetes
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.
Read the 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
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Wearable watch training group., Mobile application training group., Supervised exercise training group
- Keywords
- Diabetes Mellitus, Type 2, Physical activity, exercise behavior, exercise, smart phone, wearable technology, self-management, glycated hemoglobin (HbA1c)
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable watch training group.Behavioural
3 orientation session Watch notifies 3/week for exercise
Mobile application training group.Behavioural
3 orientation session App notifies 3/week for exercise
Benefits of app:
Cheaper Trackable and notifiable if patients don't exercise.
Supervised exercise training groupBehavioural
3/week training supervised by a physical therapist
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mobile application training group. |
| Supervised exercise training group | Sham comparator | Aerobic exercises Strengthening exercises Stretching exercises supervised by a physical therapist Receives: Behavioral: Supervised exercise training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes
Secondary outcomes (6)
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
Measured: 6 min
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.
Measured: 10 minutes
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.
Measured: 10 minutes
Assessment of muscle strength with isokinetic device
An assessment of muscle strength is typically performed as part of a patient's objective assessment.
Measured: 15 minutes
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.
Measured: 7 days
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start5 Feb 2018
- Primary completion22 Sep 2018
- Study completion5 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eren Timurtas, PT, MSc, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766802
- Sponsor's protocol ID
- 09.2017.604
- Status last verified
- Jan 2019
- First submitted
- 1 Dec 2018
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Wearable Technology and Smart Mobile Phone Applications Based Exercise Training and Supervised Exercise Training in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03766802
- Acronym / sponsor ID
- 09.2017.604
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Physical activity, exercise behavior, exercise, smart phone, wearable technology, self-management, glycated hemoglobin (HbA1c)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 22 Sep 2018 (actual)
- Study completion
- 5 May 2019 (estimated)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Wearable watch training group. | Active comparator | Behavioral: 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. |
| Mobile application training group. | Active comparator | Behavioral: 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. |
| Supervised exercise training group | Sham comparator | Behavioral: Supervised exercise training groupAerobic exercises Strengthening exercises Stretching exercises supervised by a physical therapist |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-65 No other chronic condition No exercise training background
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable watch training group.3 orientation session Watch notifies 3/week for exercise | Behavioural | Wearable watch training group. |
| 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. | Behavioural | Mobile application training group. |
| Supervised exercise training group3/week training supervised by a physical therapist | Behavioural | Supervised exercise training group |
Primary outcome
Glycated Hemoglobin (HbA1c)
Time frame: 5 minutes
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.
6 secondary outcomes
Six-Minute Walk Test
Time frame: 6 min
The forced vital capacity
Time frame: 10 minutes
Forced expiratory volume
Time frame: 10 minutes
Assessment of muscle strength with isokinetic device
Time frame: 15 minutes
International physical activity questionnaire short form (IPAQ)
Time frame: 7 days
Accelerometer
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eren Timurtas, PT, MSc principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable watch training group., Mobile application training group. and Supervised exercise training group in people with Diabetes Mellitus, Type 2, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated Hemoglobin (HbA1c) (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.