Good HealthIPSO FACTONCT01750944
Measurement of a Systolic Pressure Index at the Toe After a Walking Test
A study testing Ankle first and Toe first in people with Good Health, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of this study is to evaluate the concordance of the variation in systolic pressure indices measured at the toe and ankle after a walking test in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Good Health
- What is being tested?
- Ankle first and Toe first
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Feb 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject must have given his/her informed and signed consent
- The subject must be insured or beneficiary of a health insurance plan
Who cannot join
- The subject is in an exclusion period determined by a previous study
- The subject is under judicial protection, under tutorship or curatorship
- The subject refuses to sign the consent
- It is impossible to correctly inform the subject
- The subject is pregnant, parturient, or breastfeeding
- The subject has a contraindication for a walking test
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- Presence of mediacalcose objectified by a Doppler examination of the anterior and posterior tibial arteries, performed on the test day
- Known history of cardiovascular disease
- Poorly controlled diabetes or hypertension
- Neurological, muscular or rheumatic pathology contra-indicating a walking test
- Acute transient infection (cold-rhinitis, flu, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the Measurement of a Systolic Pressure Index at the Toe (IPSO) After a Walking Test
The main objective of this study is to evaluate the concordance of the variation in systolic pressure indices measured at the toe and ankle after a walking test in healthy volunteers.
Read the detailed description
Our secondary objectives are:
- to evaluate the concordance between left- and right-side measures: systolic pressure indices measured at the toe after a walking test (healthy volunteers)
- to evaluate the concordance between left- and right-side measures: systolic pressure indices measured at the ankle after a walking test (healthy volunteers)
- to evaluate the concordance of the variation in systolic pressure indices measured at the toe and ankle during the recuperation phase after a walking test (5 and 10 minutes after end of walking test) in healthy volunteers
- Conditions
- Good Health
- Being tested
- Ankle first, Toe first
- Keywords
- Blood pressure site, Good health, Brachial blood pressure, Ankle, Toe, Walking test, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle firstProcedure or surgery
- Brachial blood pressure on both the left and right (BBP-LR) sides is measured, as well as at the left and right ankles (BPA-LR).
- A 15 minute walking test (WT) is performed.
- BBP-LR and BPA-LR are re-measured.
- 2 hours of rest.
- BBP-LR and the blood pressure at the left and right big toes (BPT-LR) are measured.
- WT is reperformed.
- BBP-LR and BPT-LR are re-measured.
Toe firstProcedure or surgery
- Brachial blood pressure on both the left and right (BBP-LR) sides is measured, as well as at the left and right big toes (BPT-LR).
- A 15 minute walking test (WT) is performed.
- BBP-LR and BPT-LR are re-measured.
- 2 hours of rest.
- BBP-LR and the blood pressure at the left and right ankles (BPA-LR) are measured.
- WT is reperformed.
- BBP-LR and BPA-LR are re-measured.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers 1 | Experimental | The study population consists of adult, healthy volunteers randomized into two identical groups.
Intervention: ankle first Receives: Procedure: Ankle first |
| Healthy Volunteers 2 | Experimental | The study population consists of adult, healthy volunteers randomized into two identical groups.
Intervention: toe first Receives: Procedure: Toe first |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between brachial and ankle blood pressure
Measured: Before effort test (minute -15, day 0)
Difference between brachial and ankle blood pressure
Measured: After effort test (minute 0, day 0)
Difference between brachial and toe blood pressure
Measured: Before effort test (minute -15, day 0)
Difference between brachial and toe blood pressure
Measured: After effort test (minute 0, day 0)
Secondary outcomes (24)
Brachial blood pressure, left arm
Measured: Before effort test (minute -15, day 0)
Brachial blood pressure, left arm
Measured: After effort test (minute 0, day 0)
Brachial blood pressure, left arm
Measured: After effort test (minute 5, day 0)
Brachial blood pressure, left arm
Measured: After effort test (minute 10, day 0)
Brachial blood pressure, right arm
Measured: Before effort test (minute -15, day 0)
Brachial blood pressure, right arm
Measured: After effort test (minute 0, day 0)
Brachial blood pressure, right arm
Measured: After effort test (minute 5, day 0)
Brachial blood pressure, right arm
Measured: After effort test (minute 10, day 0)
Blood pressure, left big toe
Measured: Before effort test (minute -15, day 0)
Blood pressure, left big toe
Measured: After effort test (minute 0, day 0)
Blood pressure, left big toe
Measured: After effort test (minute 5, day 0)
Blood pressure, left big toe
Measured: After effort test (minute 10, day 0)
Blood pressure, right big toe
Measured: Before effort test (minute -15, day 0)
Blood pressure, right big toe
Measured: After effort test (minute 0, day 0)
Blood pressure, right big toe
Measured: After effort test (minute 5, day 0)
Blood pressure, right big toe
Measured: After effort test (minute 10, day 0)
Blood pressure, right ankle
Measured: Before effort test (minute -15, day 0)
Blood pressure, right ankle
Measured: After effort test (minute 0, day 0)
Blood pressure, right ankle
Measured: After effort test (minute 5, day 0)
Blood pressure, right ankle
Measured: After effort test (minute 10, day 0)
Blood pressure, left ankle
Measured: Before effort test (minute -15, day 0)
Blood pressure, left ankle
Measured: After effort test (minute 0, day 0)
Blood pressure, left ankle
Measured: After effort test (minute 5, day 0)
Blood pressure, left ankle
Measured: After effort test (minute 10, day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startJul 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Good HealthStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonia Perez Martin, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750944
- Sponsor's protocol ID
- LOCAL/2012/APM-02
- Other IDs
- 2012-A01432-41
- Acronym
- IPSO FACTO
- Status last verified
- Mar 2015
- First submitted
- 13 Dec 2012
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Measurement of a Systolic Pressure Index at the Toe (IPSO) After a Walking Test
- ClinicalTrials.gov ID
- NCT01750944
- Acronym / sponsor ID
- IPSO FACTO / LOCAL/2012/APM-02
- Conditions
- Good Health
- Keywords
- Blood pressure site, Good health, Brachial blood pressure, Ankle, Toe, Walking test, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 17 Dec 2012 (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 main objective of this study is to evaluate the concordance of the variation in systolic pressure indices measured at the toe and ankle after a walking test in healthy volunteers.
Detailed description
Our secondary objectives are:
- to evaluate the concordance between left- and right-side measures: systolic pressure indices measured at the toe after a walking test (healthy volunteers)
- to evaluate the concordance between left- and right-side measures: systolic pressure indices measured at the ankle after a walking test (healthy volunteers)
- to evaluate the concordance of the variation in systolic pressure indices measured at the toe and ankle during the recuperation phase after a walking test (5 and 10 minutes after end of walking test) in healthy volunteers
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers 1 | Experimental | Procedure: Ankle firstThe study population consists of adult, healthy volunteers randomized into two identical groups. Intervention: ankle first |
| Healthy Volunteers 2 | Experimental | Procedure: Toe firstThe study population consists of adult, healthy volunteers randomized into two identical groups. Intervention: toe first |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The subject must have given his/her informed and signed consent
- The subject must be insured or beneficiary of a health insurance plan
Key exclusion criteria (11 listed)
- The subject is in an exclusion period determined by a previous study
- The subject is under judicial protection, under tutorship or curatorship
- The subject refuses to sign the consent
- It is impossible to correctly inform the subject
- The subject is pregnant, parturient, or breastfeeding
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 |
|---|---|---|
| Ankle first1. Brachial blood pressure on both the left and right (BBP-LR) sides is measured, as well as at the left and right ankles (BPA-LR). 2. A 15 minute walking test (WT) is performed. 3. BBP-LR and BPA-LR are re-measured. 4. 2 hours of rest. 5. BBP-LR and the blood pressure at the left and right big toes (BPT-LR) are measured. 6. WT is reperformed. 7. BBP-LR and BPT-LR are re-measured. | Procedure or surgery | Healthy Volunteers 1 |
| Toe first1. Brachial blood pressure on both the left and right (BBP-LR) sides is measured, as well as at the left and right big toes (BPT-LR). 2. A 15 minute walking test (WT) is performed. 3. BBP-LR and BPT-LR are re-measured. 4. 2 hours of rest. 5. BBP-LR and the blood pressure at the left and right ankles (BPA-LR) are measured. 6. WT is reperformed. 7. BBP-LR and BPA-LR are re-measured. | Procedure or surgery | Healthy Volunteers 2 |
Primary outcome
Difference between brachial and ankle blood pressure
Time frame: Before effort test (minute -15, day 0)
Difference between brachial and ankle blood pressure
Time frame: After effort test (minute 0, day 0)
Difference between brachial and toe blood pressure
Time frame: Before effort test (minute -15, day 0)
Difference between brachial and toe blood pressure
Time frame: After effort test (minute 0, day 0)
24 secondary outcomes
Brachial blood pressure, left arm
Time frame: Before effort test (minute -15, day 0)
Brachial blood pressure, left arm
Time frame: After effort test (minute 0, day 0)
Brachial blood pressure, left arm
Time frame: After effort test (minute 5, day 0)
Brachial blood pressure, left arm
Time frame: After effort test (minute 10, day 0)
Brachial blood pressure, right arm
Time frame: Before effort test (minute -15, day 0)
Brachial blood pressure, right arm
Time frame: After effort test (minute 0, day 0)
Brachial blood pressure, right arm
Time frame: After effort test (minute 5, day 0)
Brachial blood pressure, right arm
Time frame: After effort test (minute 10, day 0)
Blood pressure, left big toe
Time frame: Before effort test (minute -15, day 0)
Blood pressure, left big toe
Time frame: After effort test (minute 0, day 0)
Blood pressure, left big toe
Time frame: After effort test (minute 5, day 0)
Blood pressure, left big toe
Time frame: After effort test (minute 10, day 0)
Blood pressure, right big toe
Time frame: Before effort test (minute -15, day 0)
Blood pressure, right big toe
Time frame: After effort test (minute 0, day 0)
Blood pressure, right big toe
Time frame: After effort test (minute 5, day 0)
Blood pressure, right big toe
Time frame: After effort test (minute 10, day 0)
Blood pressure, right ankle
Time frame: Before effort test (minute -15, day 0)
Blood pressure, right ankle
Time frame: After effort test (minute 0, day 0)
Blood pressure, right ankle
Time frame: After effort test (minute 5, day 0)
Blood pressure, right ankle
Time frame: After effort test (minute 10, day 0)
Blood pressure, left ankle
Time frame: Before effort test (minute -15, day 0)
Blood pressure, left ankle
Time frame: After effort test (minute 0, day 0)
Blood pressure, left ankle
Time frame: After effort test (minute 5, day 0)
Blood pressure, left ankle
Time frame: After effort test (minute 10, day 0)
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 26 Mar 2015.
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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.
Antonia Perez Martin, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle first and Toe first in people with Good Health, run by Centre Hospitalier Universitaire de Nīmes 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 2 inclusion and 11 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 26 Mar 2015. 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?
Difference between brachial and ankle blood pressure (time frame: Before effort test (minute -15, day 0)). The study lists 4 primary outcomes in all. 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 26 Mar 2015.