Evaluation of Effect of Exercise on Prescription

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00399997
• Other study ID #: 22-04-0084 JBS
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: November 15, 2006
• Last updated: December 20, 2006
• Start date: January 2005
• Est. completion date: August 2007

Study information

• Verified date: November 2006
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all patients referred to the Exercise on Prescription scheme by their general practitioner

• volunteer to participate in the randomized trial

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Exercise on Prescription

Locations

Country	Name	City	State
Denmark	Centre of Applied and Clinical Exercise Sciences, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark	Odense

Sponsors (6)

Lead Sponsor	Collaborator
University of Southern Denmark	Ministry of the Interior and Health, Denmark, National Board of Health, Denmark, The County of Ribe, The County of Vejle, The Danish Medical Research Council

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Sørensen 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal oxygen uptake at 4 and 10 months
Primary	Bodyweight and Body Mass Index at 4 and 10 months
Primary	Glycemic control at 4 and 10 months
Primary	Patient-reported physical activity level at 4 and 10 months
Primary	Patient-reported health related quality of life at 4 and 10 months
Secondary	Patient-reported amount and intensity of exercise at 4 and 10 months
Secondary	Patient-reported physical fitness at 4 and 10 months
Secondary	Patient-reported compliance with national guidelines for physical activity at 4 and 10 months