- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01085773
Effects of Nordic Walking and Exercise on Glucose Metabolism in Type 2 Diabetes Mellitus: A Randomized Controlled Trial
Effects of Nordic Walking and Exercise on Prescription on Glucose Metabolism in Type 2 Diabetes Mellitus: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Syddanmark
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Esbjerg, Syddanmark, Denmark, 6700
- Department of Endocrinology, Hospital of Southwest Denmark
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
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|
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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
|
The physical training consisted of both aerobic and strength training and took place in supervised groups.
|
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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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Glycated hemoglobin (HbA1c).
Time Frame: Baseline, after 4 months, after 1 year
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Baseline, after 4 months, after 1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Adherence, Anthropometry,Blood pressure, Lipid profile, VO2max and quality of life.
Time Frame: Baseline, after 4 months, after 1 year
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Baseline, after 4 months, after 1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bibi Gram, Ph.d student, University of Southern Denmark
- Study Chair: Jeppe Gram, MD, Ph.d., Hospital of Southwest Denamark
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2628-04
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