Peripheral Vascular DiseaseNCT01109732
Physical Activity, Function and Quality of Life in Patients After Endovascular Treatment
A study testing Systematic physical training with instructor in people with Peripheral Vascular Disease, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to investigate how systematic physical training after endovascular treatment influence the durability of the endovascular treatment and how it effects physical function, quality of life and future cardiovascular events. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Systematic physical training with instructor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2010to Jul 2013
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 55 years old or older
- successful endovascular
- living in Oslo or in the close area being able to come to physical training classes at the hospital
Who cannot join
- endovascular treatment on study-leg last 2 years
- other reasons for reduced walking function than peripheral arterial disease
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate how systematic physical training after endovascular treatment influence the durability of the endovascular treatment and how it effects physical function, quality of life and future cardiovascular events.
- Conditions
- Peripheral Vascular Disease
- Being tested
- Systematic physical training with instructor
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic physical training with instructorOther
Training 3 times per week for 6 months, the first 3 months with an instructor
| Study group | Role | What they receive |
|---|---|---|
| Systematic physical training | Experimental | Hospital-based SET two days per week for 12 weeks and one home-based exercise session every week. The group-based SET was based on The Norwegian Ullevaal Model, a modified cardiac rehabilitation program, and was slightly adjusted to be applicable to this patient group. Each SET session lasted for 60 minutes and consisted of warm-up exercises, three high-intensity, two moderate-intensity and cool-down exercises, including stretching. The exercises were generally simple aerobic dance movements and walking and involved the use of both upper and lower extremities. The warm-up exercises included large muscle movements that were repeated later in the higher-intensity intervals, but with greater force and a larger range of movement. Receives: Other: Systematic physical training with instructor |
| Treatment as of today | No intervention | The control group did not receive any additional follow-up regarding exercise at discharge beyond the general advice about the importance of exercise that is routinely provided at the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to potential occlusion
Measured: 1 year
Secondary outcomes (1)
6 Minutes Walk Test
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University College
- Responsible party
- Principal investigator, Elisabeth Bø, Oslo University Hospital
- Investigators
- Astrid Bergland, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109732
- Sponsor's protocol ID
- 2009/2192-1
- Status last verified
- Nov 2016
- First submitted
- 21 Apr 2010
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity, Function and Quality of Life in Patients After Endovascular Treatment
- ClinicalTrials.gov ID
- NCT01109732
- Acronym / sponsor ID
- 2009/2192-1
- Conditions
- Peripheral Vascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Oslo University College
- Study start
- Feb 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 23 Apr 2010 (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 investigate how systematic physical training after endovascular treatment influence the durability of the endovascular treatment and how it effects physical function, quality of life and future cardiovascular events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systematic physical training | Experimental | Other: Systematic physical training with instructorHospital-based SET two days per week for 12 weeks and one home-based exercise session every week. The group-based SET was based on The Norwegian Ullevaal Model, a modified cardiac rehabilitation program, and was slightly adjusted to be applicable to this patient group. Each SET session lasted for 60 minutes and consisted of warm-up exercises, three high-intensity, two moderate-intensity and cool-down exercises, including stretching. The exercises were generally simple aerobic dance movements and walking and involved the use of both upper and lower extremities. The warm-up exercises included large muscle movements that were repeated later in the higher-intensity intervals, but with greater force and a larger range of movement. |
| Treatment as of today | No intervention | –The control group did not receive any additional follow-up regarding exercise at discharge beyond the general advice about the importance of exercise that is routinely provided at the hospital. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 55 years old or older
- successful endovascular
- living in Oslo or in the close area being able to come to physical training classes at the hospital
Key exclusion criteria (2 listed)
- endovascular treatment on study-leg last 2 years
- other reasons for reduced walking function than peripheral arterial disease
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 |
|---|---|---|
| Systematic physical training with instructorTraining 3 times per week for 6 months, the first 3 months with an instructor | Other | Systematic physical training |
Primary outcome
Time to potential occlusion
Time frame: 1 year
1 secondary outcome
6 Minutes Walk Test
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Individual participant dataSharing planned: No
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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.
Astrid Bergland, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic physical training with instructor in people with Peripheral Vascular Disease, run by Oslo University Hospital at 1 site in Norway.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 2 Nov 2016. 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 Norway. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to potential occlusion (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2016.