Peripheral Artery DiseaseCERESNCT02833597
Claudication Evaluation During Rowing ExerciseS
An observational study of Peripheral Artery Disease, run by University Hospital, Angers at 1 site in France.
Trial summary
Check the feasibility of the collection of reliable measures of tcpO2 the lower limbs in arteriopathy when performing rowing on effort. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peripheral Artery Disease
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to Nov 2016
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with buttock pain and referred for an oximetry exercise test
Who may be able to join
- referred for an oximetry exercise test
- Patient able to walk on a treadmill
- Patient covered by the French health insurance
- Patient able to understand the protocol
- Patient agrees to be involve in the protocol and sign the consent form
Who cannot join
- any heart issues during the last 3 months
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Claudication Evaluation During Rowing ExerciseS. Rehabilitation Arteritis of Lower Limbs by Rowing
Check the feasibility of the collection of reliable measures of tcpO2 the lower limbs in arteriopathy when performing rowing on effort.
Read the detailed description
Obtaining curve values of tcpO2 interpretable when recording the effort by rowing on rowing.
Show the occurrence of ischemia in the lower limbs during recording effort by rowing on rowing
- Conditions
- Peripheral Artery Disease
- Keywords
- peripheral artery disease, transcutaneous oxygen pressure, claudication, rowing ergometer
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in transcutaneous oxygen pressure (tcpo2) value in the calf for different rowing intensities
during exercise on rowing ergoùmeter, we collect reliable measurements of TcPO2 on chest and limb and calculate the DROP index (Limb changes minus chest changes)
Measured: up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre ABRAHAM, MD; Ph.D, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833597
- Sponsor's protocol ID
- 2015-A00189-40
- Acronym
- CERES
- Status last verified
- Dec 2016
- First submitted
- 14 Jun 2016
- Last updated
- 19 Dec 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 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Claudication Evaluation During Rowing ExerciseS. Rehabilitation Arteritis of Lower Limbs by Rowing
- ClinicalTrials.gov ID
- NCT02833597
- Acronym / sponsor ID
- CERES / 2015-A00189-40
- Conditions
- Peripheral Artery Disease
- Keywords
- peripheral artery disease, transcutaneous oxygen pressure, claudication, rowing ergometer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jul 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 14 Jul 2016 (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.
Check the feasibility of the collection of reliable measures of tcpO2 the lower limbs in arteriopathy when performing rowing on effort.
Detailed description
Obtaining curve values of tcpO2 interpretable when recording the effort by rowing on rowing.
Show the occurrence of ischemia in the lower limbs during recording effort by rowing on rowing
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with buttock pain and referred for an oximetry exercise test
Key inclusion criteria (5 listed)
- referred for an oximetry exercise test
- Patient able to walk on a treadmill
- Patient covered by the French health insurance
- Patient able to understand the protocol
- Patient agrees to be involve in the protocol and sign the consent form
Key exclusion criteria (2 listed)
- any heart issues during the last 3 months
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in transcutaneous oxygen pressure (tcpo2) value in the calf for different rowing intensities
Time frame: up to 1 day
during exercise on rowing ergoùmeter, we collect reliable measurements of TcPO2 on chest and limb and calculate the DROP index (Limb changes minus chest changes)
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 19 Dec 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.
Pierre ABRAHAM, MD; Ph.D principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease, 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 5 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 19 Dec 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 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?
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?
Changes in transcutaneous oxygen pressure (tcpo2) value in the calf for different rowing intensities (time frame: up to 1 day). 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 19 Dec 2016.