- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00399997
Evaluation of Effect of Exercise on Prescription
Effect of Exercise on Prescription on Physical Activity, Physical Fitness, and Health in Patients With Lifestyle Diseases
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
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Odense, Denmark, DK-5230
- Centre of Applied and Clinical Exercise Sciences, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- all patients referred to the Exercise on Prescription scheme by their general practitioner
- volunteer to participate in the randomized trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Maximal oxygen uptake at 4 and 10 months
|
Bodyweight and Body Mass Index at 4 and 10 months
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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
Outcome Measure |
---|
Patient-reported amount and intensity of exercise at 4 and 10 months
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Patient-reported physical fitness at 4 and 10 months
|
Patient-reported compliance with national guidelines for physical activity at 4 and 10 months
|
Collaborators and Investigators
Sponsor
Collaborators
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-04-0084 JBS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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