This trial is active, not recruiting.

Conditions metabolic syndrome x, diabetes mellitus, type 2, cardiovascular diseases
Treatment exercise on prescription
Phase phase 2/phase 3
Sponsor University of Southern Denmark
Collaborator The County of Vejle
Start date January 2005
End date August 2007
Trial size 50 participants
Trial identifier NCT00399997, 22-04-0084 JBS


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Maximal oxygen uptake at 4 and 10 months
time frame:
Bodyweight and Body Mass Index at 4 and 10 months
time frame:
Glycemic control at 4 and 10 months
time frame:
Patient-reported physical activity level at 4 and 10 months
time frame:
Patient-reported health related quality of life at 4 and 10 months
time frame:

Secondary Outcomes

Patient-reported amount and intensity of exercise at 4 and 10 months
time frame:
Patient-reported physical fitness at 4 and 10 months
time frame:
Patient-reported compliance with national guidelines for physical activity at 4 and 10 months
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - all patients referred to the Exercise on Prescription scheme by their general practitioner - volunteer to participate in the randomized trial

Additional Information

Official title Effect of Exercise on Prescription on Physical Activity, Physical Fitness, and Health in Patients With Lifestyle Diseases
Principal investigator Jes Bak Sørensen, MSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2006.
Information provided to ClinicalTrials.gov by University of Southern Denmark.