Back to resultsEvaluation of Effect of Exercise on Prescription
Primary Purpose
Metabolic Syndrome X, Diabetes Mellitus, Type 2, Cardiovascular Diseases
Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Exercise on Prescription
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome X focused on measuring Exercise, Exercise referral, Lifestyle diseases, Sedentary behavior
Eligibility Criteria
Inclusion Criteria:
- all patients referred to the Exercise on Prescription scheme by their general practitioner
- volunteer to participate in the randomized trial
Sites / Locations
- Centre of Applied and Clinical Exercise Sciences, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
Outcomes
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
Full Information
NCT ID
NCT00399997
First Posted
November 15, 2006
Last Updated
December 20, 2006
Sponsor
University of Southern Denmark
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
1. Study Identification
Unique Protocol Identification Number
NCT00399997
Brief Title
Evaluation of Effect of Exercise on Prescription
Official Title
Effect of Exercise on Prescription on Physical Activity, Physical Fitness, and Health in Patients With Lifestyle Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Unknown status
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Southern Denmark
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
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X, Diabetes Mellitus, Type 2, Cardiovascular Diseases
Keywords
Exercise, Exercise referral, Lifestyle diseases, Sedentary behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Exercise on Prescription
Primary Outcome Measure Information:
Title
Maximal oxygen uptake at 4 and 10 months
Title
Bodyweight and Body Mass Index at 4 and 10 months
Title
Glycemic control at 4 and 10 months
Title
Patient-reported physical activity level at 4 and 10 months
Title
Patient-reported health related quality of life at 4 and 10 months
Secondary Outcome Measure Information:
Title
Patient-reported amount and intensity of exercise at 4 and 10 months
Title
Patient-reported physical fitness at 4 and 10 months
Title
Patient-reported compliance with national guidelines for physical activity at 4 and 10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all patients referred to the Exercise on Prescription scheme by their general practitioner
volunteer to participate in the randomized trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jes Bak Sørensen, MSc
Organizational Affiliation
Centre of Applied and Clinical Exercise Sciences, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre of Applied and Clinical Exercise Sciences, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
City
Odense
ZIP/Postal Code
DK-5230
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
16690553
Citation
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. doi: 10.1080/02813430600700027.
Results Reference
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Evaluation of Effect of Exercise on Prescription
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