- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02655627
Internet Based Exercise Training in Type 2 Diabetes
January 24, 2020 updated by: Buket AKINCI, Biruni University
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey
- Buket AKINCI
-
Istanbul, Turkey
- Istanbul University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
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.
|
|
|
Experimental: Group B
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.
|
|
|
Experimental: Group C
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
HbA1c
Time Frame: 2 months
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
fasting blood glucose
Time Frame: 2 months
|
2 months
|
|
Body fat ratio
Time Frame: 2 months
|
2 months
|
|
Body Muscle Ratio
Time Frame: 2 months
|
2 months
|
|
6 minute walking distance
Time Frame: 2 months
|
2 months
|
|
International Physical Activity Questionnaire
Time Frame: 2 months
|
2 months
|
|
Number of Steps (Mean of 7 days)
Time Frame: 2 months
|
2 months
|
|
Quadriceps Muscle Strength (for left and right)
Time Frame: 2 months
|
2 months
|
|
Euro Quality of Life-5 Dimension
Time Frame: 2 months
|
2 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
cholesterol levels
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2015
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
January 12, 2016
First Submitted That Met QC Criteria
January 12, 2016
First Posted (Estimate)
January 14, 2016
Study Record Updates
Last Update Posted (Actual)
January 27, 2020
Last Update Submitted That Met QC Criteria
January 24, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/1977
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes
-
University of North Carolina, Chapel HillAmerican Heart AssociationRecruitingType 2 Diabetes | Nutrition | Diabetes Type 2 | T2DM (Type 2 Diabetes Mellitus) | Diabetes Mellitis | T2DM | Diabetes EducationUnited States
-
Kaiser PermanenteThe Permanente Medical GroupEnrolling by invitationType 2 Diabetes | Type 2 Diabetes Mellitus (T2DM) | Type 2 Diabetes (T2D)United States
-
Endogenex, Inc.Not yet recruitingDiabetes Mellitus, Type 2 | Diabetes | Type 2 Diabetes Mellitus | Type 2 Diabetes | Type2diabetes
-
ENBIOSIS BIOTECHNOLOGIESAydin Adnan Menderes University; Izmir University of Economics; Buca Seyfi Demirsoy... and other collaboratorsNot yet recruitingType 2 Diabetes | Diabetes Mellitus Type 2Turkey (Türkiye)
-
Endogenex, Inc.Not yet recruitingDiabetes Mellitus, Type 2 | Diabetes | Type 2 Diabetes | Type 2 Diabetes Mellitus (T2DM) | Type2Diabetes
-
Medical University of GrazCompletedType 2 Diabetes | Type 2 Diabetes Mellitus (T2DM) | Type 2 Diabetes, Insulin RequiringAustria
-
University of SalamancaUniversity of Salamanca; Instituto Piaget; Escola Superior de Tecnologia da Saúde...Enrolling by invitationType 2 Diabetes Mellitus | Aging | Hyperglycemia Due to Type 2 Diabetes MellitusPortugal
-
Instituto Nacional de Ciencias Medicas y Nutricion...Active, not recruiting
-
Steno Diabetes Center CopenhagenRecruitingDiabetes | Cognitive Impairment | Type 2 Diabetes | Diabetes Mellitus Type 2 | Cognitive Decline | Type 2 Diabetes Mellitus (T2DM)Denmark
-
University of PennsylvaniaNational Institute on Aging (NIA); American Heart AssociationRecruitingType 2 Diabetes Mellitus | Type 2 Diabetes | Type II Diabetes Mellitus | Pre-diabetes | Pre-diabetic | Type II Diabetes | Type 2 Diabetes Mellitus (T2DM) | Type 2 Diabetes (T2DM) | Pre-diabetic StateUnited States
Clinical Trials on Physical activity counselling via a brochure
-
Children's Hospital of Eastern OntarioLondon Health Sciences Centre; Stollery Children's Hospital; Ontario Child Health... and other collaboratorsCompletedCongenital Heart DiseaseCanada
-
KU LeuvenFire Stress TeamNot yet recruitingPTSD | Stress, Psychological | Depressive Symptoms | Anxiety Disorders and Symptoms
-
Children's Hospital of Eastern OntarioCompleted
-
Ankara City Hospital BilkentCompletedHypertension | Physical Activity | Behavior ChangeTurkey
-
University of OttawaHopital MontfortCompletedPhysical InactivityCanada
-
McMaster UniversityThe Ottawa Hospital Academic Medical Association; Hamilton Academic Health... and other collaboratorsCompleted
-
University of Southern DenmarkMunicipality of SønderborgCompleted
-
Istanbul UniversityCompletedObesity | Physical Activity | Exercise | Bariatric SurgeryTurkey
-
Universidad Autonoma de MadridCompletedLow Back Pain | Physical ActivitySpain
-
Odense University HospitalAarhus University HospitalCompletedGestational Weight Gain | Maternal Obesity | Obstetric ComplicationsDenmark