Evaluation of Effect of Exercise on Prescription - a Psychological Perspective

Physical Inactivity Clinical Trial

— EoP  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00594360
• Other study ID #: 36/154-150775
• Secondary ID: 2005-41-5248
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: January 3, 2008
• Last updated: January 3, 2008
• Start date: November 2005
• Est. completion date: May 2008

Study information

• Verified date: December 2007
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Behavior Change
• Motivation
• Physical Inactivity

Intervention

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.

Locations

Country	Name	City	State
Denmark	Centre of Applied and Clinical Exercise Science, Institute og Sport Sciences and Clinical Biomechanics, University of Southern Denamrk	Odense

Sponsors (4)

Lead Sponsor	Collaborator
University of Southern Denmark	National Board of Health, Denmark, The County of Frederiksberg, The County of Funen, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		16 months	No
Secondary	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.		16 months	No