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

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ClinicalTrials.gov Identifier: NCT01085773
Recruitment Status : Completed
First Posted : March 12, 2010
Last Update Posted : October 31, 2022
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by:
Hospital of South West Jutland

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Exercise Behavioral: Exercise on Prescription Behavioral: Nordic Walking Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Nordic Walking and Exercise on Prescription on Glucose Metabolism in Type 2 Diabetes Mellitus: A Randomized Controlled Trial
Study Start Date : February 2005
Actual Primary Completion Date : October 2006
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Standard written information on exercise
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
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
The physical training consisted of both aerobic and strength training and took place in supervised groups.
Experimental: Nordic Walking
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Glycated hemoglobin (HbA1c). [ Time Frame: Baseline, after 4 months, after 1 year ]

Secondary Outcome Measures :
  1. Adherence, Anthropometry,Blood pressure, Lipid profile, VO2max and quality of life. [ Time Frame: Baseline, after 4 months, after 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085773


Locations
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Denmark
Department of Endocrinology, Hospital of Southwest Denmark
Esbjerg, Syddanmark, Denmark, 6700
Sponsors and Collaborators
Hospital of South West Jutland
University of Southern Denmark
Investigators
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Principal Investigator: Bibi Gram, Ph.d student University of Southern Denmark
Study Chair: Jeppe Gram, MD, Ph.d. Hospital of Southwest Denamark
More Information
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ClinicalTrials.gov Identifier: NCT01085773    
Other Study ID Numbers: 2628-04
First Posted: March 12, 2010    Key Record Dates
Last Update Posted: October 31, 2022
Last Verified: October 2022
Keywords provided by Hospital of South West Jutland:
HbA1c
Type 2 Diabetes
Lifestyle changes
Exercise
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases