Evaluation of Effect of Exercise on Prescription - a Psychological Perspective

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Physical Inactivity, Motivation, Behavior Change

Intervention / Treatment
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* Behavioral: Exercise on Prescription


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Behavioral: Exercise on Prescription<br>* 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.<br>* Other names: Open Label, Active Control, Efficacy Study, Best practice;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise Prescription, Self-efficacy, Decisional Balance, Readiness to Change, Physical Activity