Type 2 DiabetesNCT02655627
Internet Based Exercise Training in Type 2 Diabetes
A study testing Internet based exercise training, group exercise training and Physical activity counselling via a brochure in people with Type 2 Diabetes, run by Biruni University at 2 sites in Turkey (Türkiye).
Trial summary
Type 2 Diabetes Mellitus (DM) is a disease which is characterized with insulin resistance and exercise has positive effects on glycemic control and cardiovascular disease (CVD) development in these patients. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Internet based exercise training, group exercise training and Physical activity counselling via a brochure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Apr 2015to 1 Sep 2016
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HbA1c level between %6,5-11
- Patients who can reach 420 meters in 6 minutes walking test
- Patients who are available high speed internet from home, work or mobile phone
Who cannot join
- Non-Cooperation
- Uncontrolled Hypertension and cardiac arrythmia
- Severe neurological and pulmonary disorder
- Patients who had Percutan Transluminal Coronary Angiography or cardiac pacemaker
- Previous Myocardial Infarction
- Previous amputation
Show all 14Show fewer
- Major musculoskeletal problem
- Chronic renal failure
- Patients who had hip or knee prothesis within 5 years
- Diabetic ulceration pr neuropathy
- Pregnancy
- Breastfeeding
- Hemolytic anemia
- Renal anemia
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Buket AKINCI
Istanbul
Istanbul University
Istanbul
About this study
Official title: Can Internet Based Exercise Training Be an Alternative to Supervised Group Exercise Training in Patients With Type 2 Diabetes?
Type 2 Diabetes Mellitus (DM) is a disease which is characterized with insulin resistance and exercise has positive effects on glycemic control and cardiovascular disease (CVD) development in these patients. Encouraging physical activity and exercise with using internet-based technology provides; potential to reach more people via comparatively low cost, 24 hour accessibility to services and for clinician, more frequent communication ability with the patient. In literature, there is no study examined exercise training via internet in patients with Type 2 DM. For this reason, considering the lack of the literature, the investigators aimed to compare the effects of internet based combined exercise training on glycemic control, functional capacity and physical activity level with supervised group training in patients with Type 2 DM. The purpose of the study is to provide convenience of rehabilitation access, glycemic control, offer an alternative physiotherapy and rehabilitation service which can help to improve physical activity level and obtain quantitative data for the applicability and contribution of internet based exercise training in patients with Type 2 DM.
- Conditions
- Type 2 Diabetes
- Being tested
- Internet based exercise training, group exercise training, Physical activity counselling via a brochure
- Keywords
- Type 2 DM, internet based exercise training, group exercise training, glycemic control
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet based exercise trainingOther
group exercise trainingOther
Physical activity counselling via a brochureOther
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Usual Care Group: A brochure which emphasis the importance of physical activity and exercise in Type 2 DM will be given to the patients in this group after the evaluation. Receives: Other: Physical activity counselling via a brochure |
| Group B | Experimental | Supervised Clinical Exercise Training Group: Patients in this group will continue group exercise training includes aerobic and resistance training, 1 hour in a day, 3 times in a week for 8 weeks with the supervision of a researcher physiotherapist. Receives: Other: group exercise training |
| Group C | Experimental | Internet Based Exercise Training Group. the patients to this group will be a member of the web site named www.diyabetvehareket.com. The participation of the patients will be provided with the videos directing them to 1 hour in a day, 3 times in a week for 8 week both aerobic and resistance exercise training from the researcher physiotherapist. Receives: Other: Internet based exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 2 months
Secondary outcomes (8)
fasting blood glucose
Measured: 2 months
Body fat ratio
Measured: 2 months
Body Muscle Ratio
Measured: 2 months
6 minute walking distance
Measured: 2 months
International Physical Activity Questionnaire
Measured: 2 months
Number of Steps (Mean of 7 days)
Measured: 2 months
Quadriceps Muscle Strength (for left and right)
Measured: 2 months
Euro Quality of Life-5 Dimension
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startApr 2015
- Primary completionJun 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Principal investigator, Buket AKINCI, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655627
- Sponsor's protocol ID
- 2014/1977
- Status last verified
- Jan 2020
- First submitted
- 12 Jan 2016
- Last updated
- 27 Jan 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Internet Based Exercise Training Be an Alternative to Supervised Group Exercise Training in Patients With Type 2 Diabetes?
- ClinicalTrials.gov ID
- NCT02655627
- Acronym / sponsor ID
- 2014/1977
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 DM, internet based exercise training, group exercise training, glycemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- Apr 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 14 Jan 2016 (estimated)
- 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.
Type 2 Diabetes Mellitus (DM) is a disease which is characterized with insulin resistance and exercise has positive effects on glycemic control and cardiovascular disease (CVD) development in these patients. Encouraging physical activity and exercise with using internet-based technology provides; potential to reach more people via comparatively low cost, 24 hour accessibility to services and for clinician, more frequent communication ability with the patient. In literature, there is no study examined exercise training via internet in patients with Type 2 DM. For this reason, considering the lack of the literature, the investigators aimed to compare the effects of internet based combined exercise training on glycemic control, functional capacity and physical activity level with supervised group training in patients with Type 2 DM. The purpose of the study is to provide convenience of rehabilitation access, glycemic control, offer an alternative physiotherapy and rehabilitation service which can help to improve physical activity level and obtain quantitative data for the applicability and contribution of internet based exercise training in patients with Type 2 DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Physical activity counselling via a brochureUsual Care Group: A brochure which emphasis the importance of physical activity and exercise in Type 2 DM will be given to the patients in this group after the evaluation. |
| Group B | Experimental | Other: group exercise trainingSupervised Clinical Exercise Training Group: Patients in this group will continue group exercise training includes aerobic and resistance training, 1 hour in a day, 3 times in a week for 8 weeks with the supervision of a researcher physiotherapist. |
| Group C | Experimental | Other: Internet based exercise trainingInternet Based Exercise Training Group. the patients to this group will be a member of the web site named www.diyabetvehareket.com. The participation of the patients will be provided with the videos directing them to 1 hour in a day, 3 times in a week for 8 week both aerobic and resistance exercise training from the researcher physiotherapist. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HbA1c level between %6,5-11
- Patients who can reach 420 meters in 6 minutes walking test
- Patients who are available high speed internet from home, work or mobile phone
Key exclusion criteria (14 listed)
- Non-Cooperation
- Renal anemia
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 |
|---|---|---|
| Internet based exercise training | Other | Group C |
| group exercise training | Other | Group B |
| Physical activity counselling via a brochure | Other | Group A |
Primary outcome
HbA1c
Time frame: 2 months
8 secondary outcomes
fasting blood glucose
Time frame: 2 months
Body fat ratio
Time frame: 2 months
Body Muscle Ratio
Time frame: 2 months
6 minute walking distance
Time frame: 2 months
International Physical Activity Questionnaire
Time frame: 2 months
Number of Steps (Mean of 7 days)
Time frame: 2 months
Quadriceps Muscle Strength (for left and right)
Time frame: 2 months
Euro Quality of Life-5 Dimension
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet based exercise training, group exercise training and Physical activity counselling via a brochure in people with Type 2 Diabetes, run by Biruni University at 2 sites 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 3 inclusion and 14 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: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HbA1c (time frame: 2 months). 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 27 Jan 2020.