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

October 28, 2022 updated by: Hospital of South West Jutland

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

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

68

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycated hemoglobin (HbA1c).
Time Frame: Baseline, after 4 months, after 1 year
Baseline, after 4 months, after 1 year

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
Baseline, after 4 months, after 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital of South West Jutland

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (ACTUAL)

October 1, 2006

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

March 11, 2010

First Submitted That Met QC Criteria

March 11, 2010

First Posted (ESTIMATE)

March 12, 2010

Study Record Updates

Last Update Posted (ACTUAL)

October 31, 2022

Last Update Submitted That Met QC Criteria

October 28, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2628-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes

Clinical Trials on Exercise on Prescription

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe