Evaluation of Effect of Exercise on Prescription - Full Text View

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

MedlinePlus related topics: Diabetes Exercise and Physical Fitness Metabolic Syndrome

U.S. FDA Resources

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

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

Website for the Centre of Applied and Clinical Exercise Sciences This link exits the ClinicalTrials.gov site

Publications:

Sorensen JB, Skovgaard T, Puggaard L. Exercise on prescription in general practice: a systematic review. Scand J Prim Health Care. 2006 Jun;24(2):69-74. Review.

Study ID Numbers:	22-04-0084 JBS
Study First Received:	November 15, 2006
Last Updated:	December 20, 2006
ClinicalTrials.gov Identifier:	NCT00399997
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
Syndrome X
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders
Abdominal obesity metabolic syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009