Evaluation of Effect of Exercise on Prescription

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by University of Southern Denmark.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
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
First received: November 15, 2006
Last updated: December 20, 2006
Last verified: November 2006
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

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

ClinicalTrials.gov processed this record on July 24, 2014