NCT02655627

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

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

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

2 active sites

Status
completed

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

April 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

January 12, 2016

Last Update Submit

January 24, 2020

Conditions

Type 2 Diabetes

Keywords

Type 2 DMinternet based exercise traininggroup exercise trainingglycemic control

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    2 months

Secondary Outcomes (8)

  • fasting blood glucose

    2 months

  • Body fat ratio

    2 months

  • Body Muscle Ratio

    2 months

  • 6 minute walking distance

    2 months

  • International Physical Activity Questionnaire

    2 months

  • +3 more secondary outcomes

Other Outcomes (1)

  • cholesterol levels

    2 months

Study Arms (3)

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.

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.

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.

Other: Internet based exercise training

Interventions

Internet based exercise trainingOTHER
Group C
group exercise trainingOTHER
Group B
Physical activity counselling via a brochureOTHER
Group A

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Buket AKINCI

Istanbul, Turkey (Türkiye)

Location

Istanbul University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, MSc

Study Record Dates

First Submitted

January 12, 2016

First Posted

January 14, 2016

Study Start

April 1, 2015

Primary Completion

June 1, 2016

Study Completion

September 1, 2016

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

TU(2)