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NCT Number: NCT01085773

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

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.

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Key information

Conditions

Type 2 Diabetes Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Exercise Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Endocrinology, Hospital of Southwest Denmark

Esbjerg, Region Syddanmark, 6700, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise on Prescription

Behavioral

The physical training consisted of both aerobic and strength training and took place in supervised groups.

Nordic walking

Behavioral

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.

Primary outcomes

  1. Glycated hemoglobin (HbA1c).

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

Secondary outcomes

  1. Adherence, Anthropometry,Blood pressure, Lipid profile, VO2max and quality of life.

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

Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Collaborators

  • University of Southern Denmark

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Mar 12, 2010
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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