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

NCT ID: NCT01085773

Last Updated: 2022-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Exercise on Prescription

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Nordic Walking

Intervention Type BEHAVIORAL

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.

Interventions

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Exercise on Prescription

The physical training consisted of both aerobic and strength training and took place in supervised groups.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role collaborator

Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

Sponsor Role lead

Principal Investigators

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Bibi Gram, Ph.d student

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Jeppe Gram, MD, Ph.d.

Role: STUDY_CHAIR

Hospital of Southwest Denamark

Locations

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Department of Endocrinology, Hospital of Southwest Denmark

Esbjerg, Region Syddanmark, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2628-04

Identifier Type: -

Identifier Source: org_study_id

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