Evaluation of Effect of Exercise on Prescription - a Psychological Perspective (EoP)

January 3, 2008 updated by: University of Southern Denmark

Exercise on Prescription: Effects and Comparison of Psychological Parameters Physical Activity, Physical Fitness, and Health Physical Between Participants in a Danish Version of Exercise on Prescription.

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 and psychological parameters in a population of sedentary patients with increased risk of developing lifestyle diseases. The effect is evaluated using patient-reported variables.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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) Self-efficacy, 2) Readiness to change, 3) Decisional balance, 4) physical activity level, and 5) health related quality of life.

The EoP-group is compared to an intervention group receiving only motivational counselling.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5230
        • Centre of Applied and Clinical Exercise Science, Institute og Sport Sciences and Clinical Biomechanics, University of Southern Denamrk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients referred to the Exercise on Prescription scheme by their general practitioner
  • Volunteer to participate in the trial

Exclusion Criteria:

  • BMI over 35

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Behavioral: Exercise on Prescription
Exercise two times a week for two months at a physiotherapist. Afterwards exercise one time a week at a physiotherapist and self-contained training one time a week for 2 months.
Other Names:
  • Open Label, Active Control, Efficacy Study, Best practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient-reported Self-efficacy level at 4, 10 and 16 months. Patient-reported Decisional balance level at 4, 10 and 16 months. Patient-reported Readiness to change level at 4, 10 and 16 months.
Time Frame: 16 months
16 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient-reported physical activity level at 4, 10 and 16 months. . Patient-reported health related quality of life at 4, 10 and 16 months. Patient-reported compliance with national guidelines for physical activity at 4, 10 and 16 months.
Time Frame: 16 months
16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

National Board of Health, Denmark
The County of Funen, Denmark
The County of Frederiksberg

Investigators

  • Principal Investigator: Lis Puggaard, PhD, Centre of Applied and Clinical Exercise Science, Institute of Sport Sciences and Clinical Biomechanics, University of Southern Denmark, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Anticipated)

May 1, 2008

Study Completion (Anticipated)

May 1, 2008

Study Registration Dates

First Submitted

January 3, 2008

First Submitted That Met QC Criteria

January 3, 2008

First Posted (Estimate)

January 15, 2008

Study Record Updates

Last Update Posted (Estimate)

January 15, 2008

Last Update Submitted That Met QC Criteria

January 3, 2008

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 36/154-150775
  • 2005-41-5248

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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