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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by University of Southern Denmark.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
The County of Funen, Denmark
The County of Frederiksberg
National Board of Health, Denmark
Information provided by:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT00594360
First received: January 3, 2008
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Physical Inactivity
Motivation
Behavior Change
Behavioral: Exercise on Prescription
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2005
Estimated Study Completion Date: May 2008
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Open Label, Active Control, Efficacy Study, Best practice

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594360

Locations
Denmark
Centre of Applied and Clinical Exercise Science, Institute og Sport Sciences and Clinical Biomechanics, University of Southern Denamrk
Odense, Denmark, 5230
Sponsors and Collaborators
University of Southern Denmark
The County of Funen, Denmark
The County of Frederiksberg
National Board of Health, Denmark
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
  More Information

No publications provided by University of Southern Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gitte Halling, Faculty of Health Sciences, University of Southern Denmark, Denmark
ClinicalTrials.gov Identifier: NCT00594360     History of Changes
Other Study ID Numbers: 36/154-150775, 2005-41-5248
Study First Received: January 3, 2008
Last Updated: January 3, 2008
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Southern Denmark:
Exercise Prescription
Self-efficacy
Decisional Balance
Readiness to Change
Physical Activity

ClinicalTrials.gov processed this record on August 26, 2014