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Evaluation of Effect of Exercise on Prescription - a Psychological Perspective (EoP)

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ClinicalTrials.gov Identifier: NCT00594360
Recruitment Status : Unknown
Verified December 2007 by University of Southern Denmark.
Recruitment status was:  Active, not recruiting
First Posted : January 15, 2008
Last Update Posted : January 15, 2008
Sponsor:
Collaborators:
The County of Funen, Denmark
The County of Frederiksberg
National Board of Health, Denmark
Information provided by:
University of Southern Denmark

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 and psychological parameters in a population of sedentary patients with increased risk of developing lifestyle diseases. The effect is evaluated using patient-reported variables.

Condition or disease Intervention/treatment Phase
Physical Inactivity Motivation Behavior Change Behavioral: Exercise on Prescription Phase 2 Phase 3

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) Self-efficacy, 2) Readiness to change, 3) Decisional balance, 4) physical activity level, and 5) health related quality of life.

The EoP-group is compared to an intervention group receiving only motivational counselling.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise on Prescription: Effects and Comparison of Psychological Parameters Physical Activity, Physical Fitness, and Health Physical Between Participants in a Danish Version of Exercise on Prescription.
Study Start Date : November 2005
Estimated Primary Completion Date : May 2008
Estimated Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Behavioral: Exercise on Prescription
Exercise two times a week for two months at a physiotherapist. Afterwards exercise one time a week at a physiotherapist and self-contained training one time a week for 2 months.
Other Name: Open Label, Active Control, Efficacy Study, Best practice



Primary Outcome Measures :
  1. Patient-reported Self-efficacy level at 4, 10 and 16 months. Patient-reported Decisional balance level at 4, 10 and 16 months. Patient-reported Readiness to change level at 4, 10 and 16 months. [ Time Frame: 16 months ]

Secondary Outcome Measures :
  1. Patient-reported physical activity level at 4, 10 and 16 months. . Patient-reported health related quality of life at 4, 10 and 16 months. Patient-reported compliance with national guidelines for physical activity at 4, 10 and 16 months. [ Time Frame: 16 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 trial

Exclusion Criteria:

  • BMI over 35

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594360


Locations
Denmark
Centre of Applied and Clinical Exercise Science, Institute og Sport Sciences and Clinical Biomechanics, University of Southern Denamrk
Odense, Denmark, 5230
Sponsors and Collaborators
University of Southern Denmark
The County of Funen, Denmark
The County of Frederiksberg
National Board of Health, Denmark
Investigators
Principal Investigator: Lis Puggaard, PhD Centre of Applied and Clinical Exercise Science, Institute of Sport Sciences and Clinical Biomechanics, University of Southern Denmark, Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gitte Halling, Faculty of Health Sciences, University of Southern Denmark, Denmark
ClinicalTrials.gov Identifier: NCT00594360     History of Changes
Other Study ID Numbers: 36/154-150775
2005-41-5248
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: January 15, 2008
Last Verified: December 2007

Keywords provided by University of Southern Denmark:
Exercise Prescription
Self-efficacy
Decisional Balance
Readiness to Change
Physical Activity