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Evaluation of Effect of Exercise on Prescription
This study is ongoing, but not recruiting participants.
First Received: November 15, 2006   Last Updated: December 20, 2006   History of Changes
Sponsors and Collaborators: University of Southern Denmark
The County of Vejle
The County of Ribe
The Danish Medical Research Council
Ministry of the Interior and Health, Denmark
National Board of Health, Denmark
Information provided by: University of Southern Denmark
ClinicalTrials.gov Identifier: NCT00399997
  Purpose

The purpose of this study is to evaluate the effect of a primary healthcare intervention called 'Exercise on Prescription' aimed at increasing level of physical activity in a population of sedentary patients with increased risk of developing lifestyle diseases. The effect is evaluated using both objective and patient-reported variables.


Condition Intervention Phase
Metabolic Syndrome X
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Behavioral: Exercise on Prescription
Phase II
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Effect of Exercise on Prescription on Physical Activity, Physical Fitness, and Health in Patients With Lifestyle Diseases

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Maximal oxygen uptake at 4 and 10 months
  • Bodyweight and Body Mass Index at 4 and 10 months
  • Glycemic control at 4 and 10 months
  • Patient-reported physical activity level at 4 and 10 months
  • Patient-reported health related quality of life at 4 and 10 months

Secondary Outcome Measures:
  • Patient-reported amount and intensity of exercise at 4 and 10 months
  • Patient-reported physical fitness at 4 and 10 months
  • Patient-reported compliance with national guidelines for physical activity at 4 and 10 months

Estimated Enrollment: 50
Study Start Date: January 2005
Estimated Study Completion Date: August 2007
Detailed Description:

Exercise prescriptions are used for initiating a physical active lifestyle in sedentary populations.

A Danish project called ‘Exercise on Prescription’ (EoP) is implemented in primary healthcare. Patients eligible for EoP are non-institutionalised adults with medically controlled lifestyle diseases or risk factors of lifestyle diseases, who are motivated to change lifestyle, able to improve health status through a physical active lifestyle, and willing to pay a fee of €100 for the intervention.

The purpose of this study is to assess the effect on: 1) maximal oxygen uptake (VO2max), 2) bodyweight and Body Mass Index, 3) glycemic control (in patients with impaired glucose tolerance), 4) physical activity level, and 5) health related quality of life.

The EoP-group is compared to a control group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all patients referred to the Exercise on Prescription scheme by their general practitioner
  • volunteer to participate in the randomized trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399997

Locations
Denmark
Centre of Applied and Clinical Exercise Sciences, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
Odense, Denmark, DK-5230
Sponsors and Collaborators
University of Southern Denmark
The County of Vejle
The County of Ribe
The Danish Medical Research Council
Ministry of the Interior and Health, Denmark
National Board of Health, Denmark
Investigators
Principal Investigator: Jes Bak Sørensen, MSc Centre of Applied and Clinical Exercise Sciences, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
  More Information

Additional Information:
Publications:
Study ID Numbers: 22-04-0084 JBS
Study First Received: November 15, 2006
Last Updated: December 20, 2006
ClinicalTrials.gov Identifier: NCT00399997     History of Changes
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Southern Denmark:
Exercise
Exercise referral
Lifestyle diseases
Sedentary behavior

Study placed in the following topic categories:
Hyperinsulinism
Metabolic Diseases
Metabolic Syndrome X
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Disorder
Abdominal Obesity Metabolic Syndrome

Additional relevant MeSH terms:
Hyperinsulinism
Pathologic Processes
Disease
Metabolic Diseases
Metabolic Syndrome X
Syndrome
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Diseases
Insulin Resistance
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 11, 2009