Metabolic Syndrome XPhase 2/3NCT00399997
Evaluation of Effect of Exercise on Prescription
A Phase 2/3 study testing Exercise on Prescription in people with Metabolic Syndrome X and Diabetes Mellitus, Type 2, run by University of Southern Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome X, Diabetes Mellitus, Type 2, Cardiovascular Diseases
- What is being tested?
- Exercise on Prescription
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2005to Aug 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients referred to the Exercise on Prescription scheme by their general practitioner
- volunteer to participate in the randomized trial
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Centre of Applied and Clinical Exercise Sciences, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
Odense, DK-5230
About this study
Official title: Effect of Exercise on Prescription on Physical Activity, Physical Fitness, and Health in Patients With Lifestyle Diseases
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.
Read the 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) 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.
- Being tested
- Exercise on Prescription
- Keywords
- Exercise, Exercise referral, Lifestyle diseases, Sedentary behavior
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise on PrescriptionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2006 (estimated)
- Study startJan 2005
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- The County of Vejle, The County of Ribe, The Danish Medical Research Council, Ministry of the Interior and Health, Denmark, National Board of Health, Denmark
- Investigators
- Jes Bak Sørensen, MSc, Principal investigator, Centre of Applied and Clinical Exercise Sciences, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399997
- Sponsor's protocol ID
- 22-04-0084 JBS
- Status last verified
- Nov 2006
- First submitted
- 15 Nov 2006
- Last updated
- 22 Dec 2006
- Results posted
- No
Publications
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.
PubMed 16690553
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise on Prescription on Physical Activity, Physical Fitness, and Health in Patients With Lifestyle Diseases
- ClinicalTrials.gov ID
- NCT00399997
- Acronym / sponsor ID
- 22-04-0084 JBS
- Keywords
- Exercise, Exercise referral, Lifestyle diseases, Sedentary behavior
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- The County of Vejle, The County of Ribe, The Danish Medical Research Council, Ministry of the Interior and Health, Denmark, National Board of Health, Denmark
- Study start
- Jan 2005
- Study completion
- Aug 2007
- First posted
- 16 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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) 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- all patients referred to the Exercise on Prescription scheme by their general practitioner
- volunteer to participate in the randomized trial
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise on Prescription | Behavioural | – |
Primary outcome
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2006.
- Background: PubMed 16690553Sorensen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jes Bak Sørensen, MSc principal investigator
Centre of Applied and Clinical Exercise Sciences, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Exercise on Prescription in people with Metabolic Syndrome X and Diabetes Mellitus, Type 2, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal oxygen uptake at 4 and 10 months. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00399997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2006.