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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085773
• Other study ID #: 2628-04
• Status: Completed
• Phase: Phase 2
• Start date: February 2005
• Est. completion date: December 2007

Study information

• Verified date: October 2022
• Source: Hospital of South West Jutland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2007
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Exercise
• Type 2 Diabetes

Intervention

Behavioral:
• Exercise on Prescription
The physical training consisted of both aerobic and strength training and took place in supervised groups.
• 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.

Locations

Country	Name	City	State
Denmark	Department of Endocrinology, Hospital of Southwest Denmark	Esbjerg	Syddanmark

Sponsors (2)

Lead Sponsor	Collaborator
Hospital of South West Jutland	University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated hemoglobin (HbA1c).		Baseline, after 4 months, after 1 year
Secondary	Adherence, Anthropometry,Blood pressure, Lipid profile, VO2max and quality of life.		Baseline, after 4 months, after 1 year