Clinical trial NCT00399997: Evaluation of Effect of Exercise on Prescription
Official title: Effect of Exercise on Prescription on Physical Activity, Physical Fitness, and Health in Patients With Lifestyle Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Metabolic Syndrome X
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Keywords: Exercise
Exercise referral
Lifestyle diseases
Sedentary behavior
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: The County of Vejle
name: The County of Ribe
name: The Danish Medical Research Council
name: Ministry of the Interior and Health, Denmark
name: National Board of Health, Denmark
First posted: 2006-11-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Maximal oxygen uptake at 4 and 10 months
measure: Bodyweight and Body Mass Index at 4 and 10 months
measure: Glycemic control at 4 and 10 months
measure: Patient-reported physical activity level at 4 and 10 months
measure: Patient-reported health related quality of life at 4 and 10 months
Secondary outcomes:
measure: Patient-reported amount and intensity of exercise at 4 and 10 months
measure: Patient-reported physical fitness at 4 and 10 months
measure: Patient-reported compliance with national guidelines for physical activity at 4 and 10 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Centre of Applied and Clinical Exercise Sciences, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
Study officials:
affiliation: Centre of Applied and Clinical Exercise Sciences, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
name: Jes Bak Sørensen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sorensen JB, Skovgaard T, Puggaard L. Exercise on prescription in general practice: a systematic review. Scand J Prim Health Care. 2006 Jun;24(2):69-74. doi: 10.1080/02813430600700027.