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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	20 Years to 80 Years (Adult, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Denmark
Department of Endocrinology, Hospital of Southwest Denmark
Esbjerg, Syddanmark, Denmark, 6700

Sponsors and Collaborators

Hospital of South West Denmark

University of Southern Denmark

Investigators

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT01085773 History of Changes
Other Study ID Numbers:	2628-04
First Posted:	March 12, 2010
Last Update Posted:	March 12, 2010
Last Verified:	January 2005

Keywords provided by Hospital of South West Denmark:

HbA1c; Type 2 Diabetes; Lifestyle changes; Exercise

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases