NCT00594360

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

January 15, 2008

Status Verified

December 1, 2007

Enrollment Period

2.5 years

First QC Date

January 3, 2008

Last Update Submit

January 3, 2008

Conditions

Physical InactivityMotivationBehavior Change

Keywords

Exercise PrescriptionSelf-efficacyDecisional BalanceReadiness to ChangePhysical Activity

Outcome Measures

Primary Outcomes (1)

  • 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.

    16 months

Secondary Outcomes (1)

  • 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.

    16 months

Study Arms (1)

1

ACTIVE COMPARATOR
Behavioral: Exercise on Prescription

Interventions

Exercise on PrescriptionBEHAVIORAL

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.

Also known as: Open Label, Active Control, Efficacy Study, Best practice
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • BMI over 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Odense, 5230, Denmark

Location

Related Publications (1)

  • Bredahl TV, Puggaard L, Roessler KK. Exercise on Prescription. Effect of attendance on participants' psychological factors in a Danish version of Exercise on Prescription: a study protocol. BMC Health Serv Res. 2008 Jun 26;8:139. doi: 10.1186/1472-6963-8-139.

    PMID: 18582371DERIVED

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Interventions

Practice Guidelines as Topic

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Guidelines as TopicQuality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Lis Puggaard, PhD

    Centre of Applied and Clinical Exercise Science, Institute of Sport Sciences and Clinical Biomechanics, University of Southern Denmark, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2008

First Posted

January 15, 2008

Study Start

November 1, 2005

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

January 15, 2008

Record last verified: 2007-12

Locations

DK(1)