NCT01750944

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

December 13, 2012

Last Update Submit

March 25, 2015

Conditions

Good Health

Keywords

Blood pressure siteGood healthBrachial blood pressureAnkleToeWalking testExercise

Outcome Measures

Primary Outcomes (4)

  • Difference between brachial and ankle blood pressure

    Before effort test (minute -15, day 0)

  • Difference between brachial and ankle blood pressure

    After effort test (minute 0, day 0)

  • Difference between brachial and toe blood pressure

    Before effort test (minute -15, day 0)

  • Difference between brachial and toe blood pressure

    After effort test (minute 0, day 0)

Secondary Outcomes (24)

  • Brachial blood pressure, left arm

    Before effort test (minute -15, day 0)

  • Brachial blood pressure, left arm

    After effort test (minute 0, day 0)

  • Brachial blood pressure, left arm

    After effort test (minute 5, day 0)

  • Brachial blood pressure, left arm

    After effort test (minute 10, day 0)

  • Brachial blood pressure, right arm

    Before effort test (minute -15, day 0)

  • +19 more secondary outcomes

Other Outcomes (5)

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

    Day 0

  • The volunteer is an athlete? yes/no

    Day 0; baseline

  • The volunteer drank coffee before the test? yes/no

    Day 0; baseline

  • +2 more other outcomes

Study Arms (2)

Healthy Volunteers 1

EXPERIMENTAL

The study population consists of adult, healthy volunteers randomized into two identical groups. Intervention: ankle first

Procedure: Ankle first

Healthy Volunteers 2

EXPERIMENTAL

The study population consists of adult, healthy volunteers randomized into two identical groups. Intervention: toe first

Procedure: Toe first

Interventions

Ankle firstPROCEDURE

1. 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.

Healthy Volunteers 1
Toe firstPROCEDURE

1. 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.

Healthy Volunteers 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Antonia Perez Martin, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2012

First Posted

December 17, 2012

Study Start

July 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

FR(1)