Popliteal Artery EntrapmentPAESNCT05584917
Physical Activity Return After Popliteal Artery Entrapement Syndrome Surgery
A study testing tegner acticity scale in people with Popliteal Artery Entrapment, run by University Hospital, Angers at 1 site in France.
Trial summary
evaluation of physical activity return after popliteal artery entrapement syndrome surgery with the tegner activity scale Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Popliteal Artery Entrapment
- What is being tested?
- tegner acticity scale
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2022to 28 Feb 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- popliteal artery entrapement syndrome surgery between 2010 and 2020 at the university center of Angers
Who cannot join
- denied to participate
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital
Angers
Eva Deveze, Dr, 0686480820, Eva.Deveze@chu-angers.fr
About this study
Official title: Physical Activity Return After Popliteal Artery Entrapement Syndrome Surgery With Tegner Activity Scale
evaluation of physical activity return after popliteal artery entrapement syndrome surgery with the tegner activity scale
- Conditions
- Popliteal Artery Entrapment
- Being tested
- tegner acticity scale
- Medical subject headings
- Popliteal Artery Entrapment Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tegner acticity scaleBehavioural
phone call to complete the tegner activity scale after surgery
| Study group | Role | What they receive |
|---|---|---|
| surgery patient | Experimental | phone call after surgery to answer the tegner activity scale Receives: Behavioral: tegner acticity scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison
comparison between tegner activity scale results before and after surgery. Tegner activity scale is from 0 to 10, minimum 0 and maximum 10. Higher score means a better outcome
Measured: change from baseline of the tegner activity scale 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Dec 2022
- Primary completion11 Jun 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Popliteal Artery EntrapmentStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584917
- Sponsor's protocol ID
- 49RC22_0305
- Acronym
- PAES
- Status last verified
- Oct 2022
- First submitted
- 11 Oct 2022
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Return After Popliteal Artery Entrapement Syndrome Surgery With Tegner Activity Scale
- ClinicalTrials.gov ID
- NCT05584917
- Acronym / sponsor ID
- PAES / 49RC22_0305
- Conditions
- Popliteal Artery Entrapment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 11 Jun 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 18 Oct 2022 (actual)
- 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.
evaluation of physical activity return after popliteal artery entrapement syndrome surgery with the tegner activity scale
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgery patient | Experimental | Behavioral: tegner acticity scalephone call after surgery to answer the tegner activity scale |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- popliteal artery entrapement syndrome surgery between 2010 and 2020 at the university center of Angers
Key exclusion criteria (1 listed)
- denied to participate
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 |
|---|---|---|
| tegner acticity scalephone call to complete the tegner activity scale after surgery | Behavioural | surgery patient |
Primary outcome
comparison
Time frame: change from baseline of the tegner activity scale 1 year after surgery
comparison between tegner activity scale results before and after surgery. Tegner activity scale is from 0 to 10, minimum 0 and maximum 10. Higher score means a better outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Popliteal Artery Entrapment
Not yet recruitingObservational study
Surgical Treatment of Functional Popliteal Artery Entrapment Syndrome: Short- and Mid-Term Results
Popliteal Artery Entrapment Syndrome
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tegner acticity scale in people with Popliteal Artery Entrapment, run by University Hospital, Angers at 1 site in France.
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 1 inclusion and 1 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 29 Dec 2022. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Deveze, Dr (0686450820, Eva.Deveze@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison (time frame: change from baseline of the tegner activity scale 1 year after surgery). 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 29 Dec 2022.