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Completed

NCT Number: NCT01750944

Measurement of a Systolic Pressure Index at the Toe 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.

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Key information

Conditions

Good Health Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject must have given his/her informed and signed consent
  • The subject must be insured or beneficiary of a health insurance plan

Exclusion criteria

  • 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
  • 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.)

Treatment and study plan

Ankle first

Procedure
  • 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 first

Procedure
  • 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.

Primary outcomes

  1. Difference between brachial and ankle blood pressure

    Time frame: Before effort test (minute -15, day 0)

  2. Difference between brachial and ankle blood pressure

    Time frame: After effort test (minute 0, day 0)

  3. Difference between brachial and toe blood pressure

    Time frame: Before effort test (minute -15, day 0)

  4. Difference between brachial and toe blood pressure

    Time frame: After effort test (minute 0, day 0)

Secondary outcomes

  1. Brachial blood pressure, left arm

    Time frame: Before effort test (minute -15, day 0)

  2. Brachial blood pressure, left arm

    Time frame: After effort test (minute 0, day 0)

  3. Brachial blood pressure, left arm

    Time frame: After effort test (minute 5, day 0)

  4. Brachial blood pressure, left arm

    Time frame: After effort test (minute 10, day 0)

  5. Brachial blood pressure, right arm

    Time frame: Before effort test (minute -15, day 0)

  6. Brachial blood pressure, right arm

    Time frame: After effort test (minute 0, day 0)

  7. Brachial blood pressure, right arm

    Time frame: After effort test (minute 5, day 0)

  8. Brachial blood pressure, right arm

    Time frame: After effort test (minute 10, day 0)

  9. Blood pressure, left big toe

    Time frame: Before effort test (minute -15, day 0)

  10. Blood pressure, left big toe

    Time frame: After effort test (minute 0, day 0)

  11. Blood pressure, left big toe

    Time frame: After effort test (minute 5, day 0)

  12. Blood pressure, left big toe

    Time frame: After effort test (minute 10, day 0)

  13. Blood pressure, right big toe

    Time frame: Before effort test (minute -15, day 0)

  14. Blood pressure, right big toe

    Time frame: After effort test (minute 0, day 0)

  15. Blood pressure, right big toe

    Time frame: After effort test (minute 5, day 0)

  16. Blood pressure, right big toe

    Time frame: After effort test (minute 10, day 0)

  17. Blood pressure, right ankle

    Time frame: Before effort test (minute -15, day 0)

  18. Blood pressure, right ankle

    Time frame: After effort test (minute 0, day 0)

  19. Blood pressure, right ankle

    Time frame: After effort test (minute 5, day 0)

  20. Blood pressure, right ankle

    Time frame: After effort test (minute 10, day 0)

  21. Blood pressure, left ankle

    Time frame: Before effort test (minute -15, day 0)

  22. Blood pressure, left ankle

    Time frame: After effort test (minute 0, day 0)

  23. Blood pressure, left ankle

    Time frame: After effort test (minute 5, day 0)

  24. Blood pressure, left ankle

    Time frame: After effort test (minute 10, day 0)

Other outcomes

  1. Time at which the tests were performed (hh:mm)

    Time frame: Day 0

  2. The volunteer is an athlete? yes/no

    Time frame: Day 0; baseline

  3. The volunteer drank coffee before the test? yes/no

    Time frame: Day 0; baseline

  4. The volunteer is a smoker? yes/no

    Time frame: Day 0; baseline

  5. Description of treatments currently being taken

    Time frame: Day 0; baseline

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Validation of the Measurement of a Systolic Pressure Index at the Toe (IPSO) After a Walking Test

Acronym: IPSO FACTO

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 17, 2012
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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