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

Primary Purpose

Type 2 Diabetes, Exercise

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Exercise on Prescription
Nordic Walking
Sponsored by
Hospital of South West Jutland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring HbA1c, Type 2 Diabetes, Lifestyle changes, Exercise

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Endocrinology, Hospital of Southwest Denmark

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Standard written information on exercise

Exercise on Prescription

Nordic Walking

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

Glycated hemoglobin (HbA1c).

Secondary Outcome Measures

Adherence, Anthropometry,Blood pressure, Lipid profile, VO2max and quality of life.

Full Information

First Posted
March 11, 2010
Last Updated
October 28, 2022
Sponsor
Hospital of South West Jutland
Collaborators
University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01085773
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital of South West Jutland
Collaborators
University of Southern Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Exercise
Keywords
HbA1c, Type 2 Diabetes, Lifestyle changes, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard written information on exercise
Arm Type
No Intervention
Arm Description
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.
Arm Title
Exercise on Prescription
Arm Type
Experimental
Arm Description
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
Arm Title
Nordic Walking
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise on Prescription
Intervention Description
The physical training consisted of both aerobic and strength training and took place in supervised groups.
Intervention Type
Behavioral
Intervention Name(s)
Nordic Walking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glycated hemoglobin (HbA1c).
Time Frame
Baseline, after 4 months, after 1 year
Secondary Outcome Measure Information:
Title
Adherence, Anthropometry,Blood pressure, Lipid profile, VO2max and quality of life.
Time Frame
Baseline, after 4 months, after 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bibi Gram, Ph.d student
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeppe Gram, MD, Ph.d.
Organizational Affiliation
Hospital of Southwest Denamark
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Endocrinology, Hospital of Southwest Denmark
City
Esbjerg
State/Province
Syddanmark
ZIP/Postal Code
6700
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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