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Clinical Trials/NCT01085773
NCT01085773
Completed
Phase 2

Effects of Nordic Walking and Exercise on Prescription on Glucose Metabolism in Type 2 Diabetes Mellitus: A Randomized Controlled Trial

Esbjerg Hospital - University Hospital of Southern Denmark1 site in 1 country68 target enrollmentFebruary 2005

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
Esbjerg Hospital - University Hospital of Southern Denmark
Enrollment
68
Locations
1
Primary Endpoint
Glycated hemoglobin (HbA1c).
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The objective of this randomized controlled trial was to evaluate the effects of two different physical exercise programs aimed at long-term lifestyle changes in physical activity in patients with Type 2 Diabetes, with glucose metabolism evaluated by HbA1c as the primary outcome.

Detailed Description

Physical training and exercise is considered a cornerstone in the treatment of Type 2 Diabetes Mellitus. Programs which include physical activity as a component in the treatment of Type 2 Diabetes as well as other chronic diseases have in Denmark and other countries been based on "Exercise on Prescription schemes". In Denmark, these schemes have focused on individual behavioral change and an exercise program for 16 weeks. No studies have documented whether "Exercise on Prescription" helps patients with Type 2 Diabetes to change their lifestyle behavior or whether it has a positive impact on measurements for physical capacity and glucose metabolism. Nordic Walking is a fitness type of walking; incorporating the use of specially designed walking sticks. Nordic Walking focuses on aerobic training where the additional activity of the arms increases a person's oxygen uptake and energy expenditure. In Denmark, many activity programs and concepts such as Exercise on Prescription and Nordic Walking are recommended to patients with Type 2 Diabetes but their efficacy has not been demonstrated. It is unknown whether one specific type of physical training program is more suitable than another, when comparing the physical effects as well as the ability to induce good compliance and change in lifestyle. The aim of this randomized, controlled trial was to evaluate the effect of two different physical exercise programs lasting 4 months aiming at introducing long term life style changes in physical activity with a follow-up period of 8 months in patients with type 2 diabetes.

Registry
clinicaltrials.gov
Start Date
February 2005
End Date
December 2007
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Esbjerg Hospital - University Hospital of Southern Denmark

Eligibility Criteria

Inclusion Criteria

  • Type 2 Diabetes for more than one year,
  • HbA1c in the range of 7-10 %,
  • BMI \> 25 kg/m2,
  • Age 25-80 years
  • Stable antidiabetic treatment for at least 3 month before inclusion.

Exclusion Criteria

  • Participants with symptomatic heart disease (NYHA 2-4)
  • Ischemia in lower extremities,
  • Myocardial infarction within the previous 3 months
  • Lung disease

Outcomes

Primary Outcomes

Glycated hemoglobin (HbA1c).

Time Frame: Baseline, after 4 months, after 1 year

Secondary Outcomes

  • Adherence, Anthropometry,Blood pressure, Lipid profile, VO2max and quality of life.(Baseline, after 4 months, after 1 year)

Study Sites (1)

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