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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02655627
Other study ID # 2014/1977
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2015
Est. completion date September 1, 2016

Study information

Verified date January 2020
Source Biruni University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date September 1, 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 35 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
Internet based exercise training

group exercise training

Physical activity counselling via a brochure


Locations

Country Name City State
Turkey Buket AKINCI Istanbul
Turkey Istanbul University Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Biruni University Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other cholesterol levels 2 months
Primary HbA1c 2 months
Secondary fasting blood glucose 2 months
Secondary Body fat ratio 2 months
Secondary Body Muscle Ratio 2 months
Secondary 6 minute walking distance 2 months
Secondary International Physical Activity Questionnaire 2 months
Secondary Number of Steps (Mean of 7 days) 2 months
Secondary Quadriceps Muscle Strength (for left and right) 2 months
Secondary Euro Quality of Life-5 Dimension 2 months
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