Evaluation of Effect of Exercise on Prescription

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 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
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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) 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.

Official Title
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Effect of Exercise on Prescription on Physical Activity, Physical Fitness, and Health in Patients With Lifestyle Diseases

Conditions
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Metabolic Syndrome X, Diabetes Mellitus, Type 2, Cardiovascular Diseases

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 randomized trial

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Exercise on Prescription|nan|

What is the study measuring?
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Primary Outcome Measures

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

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Exercise referral, Lifestyle diseases, Sedentary behavior