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

This study has been completed.
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by:
Hospital of South West Denmark
ClinicalTrials.gov Identifier:
NCT01085773
First received: March 11, 2010
Last updated: NA
Last verified: January 2005
History: No changes posted
  Purpose

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 Intervention Phase
Type 2 Diabetes
Exercise
Behavioral: Exercise on Prescription
Behavioral: Nordic Walking
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Hospital of South West Denmark:

Primary Outcome Measures:
  • Glycated hemoglobin (HbA1c). [ Time Frame: Baseline, after 4 months, after 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adherence, Anthropometry,Blood pressure, Lipid profile, VO2max and quality of life. [ Time Frame: Baseline, after 4 months, after 1 year ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: February 2005
Study Completion Date: December 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Exercise on Prescription
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.
Other Name: Nordic Walking

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085773

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

No publications provided

ClinicalTrials.gov Identifier: NCT01085773     History of Changes
Other Study ID Numbers: 2628-04
Study First Received: March 11, 2010
Last Updated: March 11, 2010
Health Authority: Denmark: Danish Dataprotection Agency

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

ClinicalTrials.gov processed this record on October 19, 2014