Evaluation of Effect of Exercise on Prescription

Phase 2

• Conditions: Metabolic Syndrome X; Diabetes Mellitus, Type 2; Cardiovascular Diseases

• Registration Number: NCT00399997
• Lead Sponsor: 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 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

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 Timeline

• Study Start: 2005-01
• Status Verified: 2006-11
• Study First Submitted: 2006-11-15
• Study First Submitted QC: 2006-11-15
• Study First Posted: 2006-11-16
• Last Update Submitted: 2006-12-20
• Last Update Posted: 2006-12-22
• Study Completion: 2007-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• all patients referred to the Exercise on Prescription scheme by their general practitioner
• volunteer to participate in the randomized trial

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Centre of Applied and Clinical Exercise Sciences, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark; 🇩🇰 Odense, Denmark