NCT01085773

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for phase_2 type-2-diabetes

Timeline
Completed

Started Feb 2005

Longer than P75 for phase_2 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2010

Completed
Last Updated

October 31, 2022

Status Verified

October 1, 2022

Enrollment Period

1.7 years

First QC Date

March 11, 2010

Last Update Submit

October 28, 2022

Conditions

Type 2 DiabetesExercise

Keywords

HbA1cType 2 DiabetesLifestyle changesExercise

Outcome Measures

Primary Outcomes (1)

  • Glycated hemoglobin (HbA1c).

    Baseline, after 4 months, after 1 year

Secondary Outcomes (1)

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

    Baseline, after 4 months, after 1 year

Study Arms (3)

Standard written information on exercise

NO INTERVENTION

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.

Exercise on Prescription

EXPERIMENTAL

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

Nordic Walking

EXPERIMENTAL

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

Interventions

Exercise on PrescriptionBEHAVIORAL

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

Exercise on Prescription
Nordic WalkingBEHAVIORAL

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.

Nordic Walking

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes for more than one year,
  • HbA1c in the range of 7-10 %,
  • BMI \> 25 kg/m2,
  • Age 25-80 years

You may not qualify if:

  • Participants with symptomatic heart disease (NYHA 2-4)
  • Ischemia in lower extremities,
  • Myocardial infarction within the previous 3 months
  • Lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Hospital of Southwest Denmark

Esbjerg, Region Syddanmark, 6700, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Interventions

Nordic Walking

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

WalkingLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Bibi Gram, Ph.d student

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

  • Jeppe Gram, MD, Ph.d.

    Hospital of Southwest Denamark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 11, 2010

First Posted

March 12, 2010

Study Start

February 1, 2005

Primary Completion

October 1, 2006

Study Completion

December 1, 2007

Last Updated

October 31, 2022

Record last verified: 2022-10

Locations

DK(1)