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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes, Exercise

Intervention / Treatment
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* Behavioral: Exercise on Prescription
* Behavioral: Nordic Walking


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard written information on exercise<br>The Control group got the diabetes outpatients clinics standard written information on exercise as a part of the treatment for Type 2 Diabetes and were, like other Type 2 Diabetes patients in the clinic, advised at inclusion to be physically active. | |
| Experimental: Exercise on Prescription<br>In Denmark, Exercise on Prescription have focused on individual behavioral change and an exercise program for 16 weeks. The physical training consisted of both aerobic and strength training and took place in supervised groups | Behavioral: Exercise on Prescription<br>* The physical training consisted of both aerobic and strength training and took place in supervised groups.<br>|
| Experimental: Nordic Walking<br>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. | Behavioral: Nordic Walking<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated hemoglobin (HbA1c). |  | Baseline, after 4 months, after 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence, Anthropometry,Blood pressure, Lipid profile, VO2max and quality of life. |  | Baseline, after 4 months, after 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HbA1c, Type 2 Diabetes, Lifestyle changes, Exercise