Clinical trial NCT01085773: Effects of Nordic Walking and Exercise on Glucose Metabolism in Type 2 Diabetes Mellitus: A Randomized Controlled Trial
Official title: Effects of Nordic Walking and Exercise on Prescription on Glucose Metabolism in Type 2 Diabetes Mellitus: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Exercise
Keywords: HbA1c
Type 2 Diabetes
Lifestyle changes
Exercise
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2010-03-12
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Glycated hemoglobin (HbA1c).
timeFrame: Baseline, after 4 months, after 1 year
Secondary outcomes:
measure: Adherence, Anthropometry,Blood pressure, Lipid profile, VO2max and quality of life.
timeFrame: Baseline, after 4 months, after 1 year
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Department of Endocrinology, Hospital of Southwest Denmark
state: Syddanmark
Study officials:
affiliation: University of Southern Denmark
name: Bibi Gram, Ph.d student
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital of Southwest Denamark
name: Jeppe Gram, MD, Ph.d.
role: STUDY_CHAIR
References: