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Completed

NCT Number: NCT00485147

Locomotion and Global Positioning System in Arterial Disease

The maximal walking distance (MWD) performed on treadmill (TT) remains the gold standard in estimating the walking capacity of patients suffering from peripheral arterial disease (PAD) with intermittent claudication, although treadmills are not accessible to most physicians. We hypothesized that global positioning system (GPS) recordings could monitor community-based outdoor walking and provide valid information on walking capacity in PAD patients.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Behavior Cardiovascular Diseases Disease Intermittent Claudication Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier universitaire

Angers, 49933, France

About this study

The study has two main objectives, conducted together. Each objective include several phases.

Objective 1: technical validation of GPS measurements in healthy subjects.

phase 1: technical validation of a GPS device to study outdoor walking (completed).

phase 2: comparison and use of various GPS devices (intra- and inter-GPS variability) in the study outdoor walking (on-going).

phase 3: study of several factors that could influence accuracy of GPS measurements as walking speed, environment, sampling frequency and others technical features as the WAAS/EGNOS function (on-going).

Objective 2: Application in PAD patients to study walking capacity under free-living conditions

phase 1: comparison of GPS measurements (maximal walking distance) with the gold standard treadmill measurement of maximal walking distance (completed).

phase 2: analysis of the variability of the walking capacity under free-living conditions from GPS measurements (completed).

phase 3: study of reliability and sensibility (effect of treatment) of GPS measurements (on-going).

phase 4: study of the relationship between laboratory measurements of walking capacity and GPS-derived parameters.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Ankle to Brachial Index (ABI) < 0.95 for PAD patients
  • Age > 18 years old
  • Able to walk on treadmill

Exclusion criteria

  • limb pain of potential non-vascular origin
  • myocardial infraction in the last six months
  • uncontrolled angina pectoris

Treatment and study plan

Recording of GPS during a free walking in a public park

Procedure

Analyse the clinical change after surgery from GPS measurements and compare it with laboratory measurement.

Primary outcomes

  1. Validate the ability of GPS to detect walking and resting bouts and to accurately estimate walking speed and distance in normal subjects.

    Time frame: 2 years

  2. Measurement of maximal walking distance using GPS and comparison with treadmill measurement in PAD patients.

    Time frame: 2 years

Secondary outcomes

  1. Determine the variability of the walking capacity and its potential determinants in PAD patients.

    Time frame: 3 years

  2. Analyse the reliability and sensibility of GPS measurements of the walking capacity in PAD patients.

    Time frame: 4 years

  3. Analyse potential factors that could affect the accuracy of GPS measurements

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Collaborators

  • Société Française de Médecine Vasculaire

Registry information

Official study title

Study of Human Locomotion With Global Positioning System. Application to Patients With Peripheral Arterial Disease

Acronym: Starter-GPS

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jun 12, 2007
Registry last updated
Jul 2, 2012

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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