NCT00399997

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.

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
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 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

January 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

December 22, 2006

Status Verified

November 1, 2006

First QC Date

November 15, 2006

Last Update Submit

December 20, 2006

Conditions

Metabolic Syndrome XDiabetes Mellitus, Type 2Cardiovascular Diseases

Keywords

ExerciseExercise referralLifestyle diseasesSedentary behavior

Outcome Measures

Primary Outcomes (5)

  • Maximal oxygen uptake at 4 and 10 months

  • Bodyweight and Body Mass Index at 4 and 10 months

  • Glycemic control at 4 and 10 months

  • Patient-reported physical activity level at 4 and 10 months

  • Patient-reported health related quality of life at 4 and 10 months

Secondary Outcomes (3)

  • Patient-reported amount and intensity of exercise at 4 and 10 months

  • Patient-reported physical fitness at 4 and 10 months

  • Patient-reported compliance with national guidelines for physical activity at 4 and 10 months

Interventions

Exercise on PrescriptionBEHAVIORAL

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 randomized trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Odense, DK-5230, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 16690553BACKGROUND

MeSH Terms

Conditions

Metabolic SyndromeDiabetes Mellitus, Type 2Cardiovascular DiseasesMotor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System DiseasesBehavior

Study Officials

  • Jes Bak Sørensen, MSc

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

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 15, 2006

First Posted

November 16, 2006

Study Start

January 1, 2005

Study Completion

August 1, 2007

Last Updated

December 22, 2006

Record last verified: 2006-11

Locations

DK(1)