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NCT Number: NCT01141361

Feasibility of Home-based Measurement of Walking Capacity Using Global Positioning System in Peripheral Artery Disease

The purpose of this study is to assess the feasibility of home-based measurement of walking capacity in peripheral arterial disease (PAD) patients, uing the Global Positioning System (GPS). This study should state if the GPS technique could be used in clinical routine in order to assess walking capacity in PAD patients. Patients will be assessed a first time (test 1) and six months later (test 2).

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Key information

About this study

The measurement of walking capacity in PAD patients is an important step in the management of such patients. The gold standard method to assess this walking capacity is the measurement of the maximal walking distance on a treadmill. However, treadmill measurement are not readily accessible and the relationship with free-living walking capacity is, although not well known, weak. A novel approach was developed using a Global Positioning System in order to assess community-based walking capacity. This method showed interesting results, validating the technique, but was limited to one laboratory and to the place where the measurements were performed. The next step is therefore to assess the feasibility of home-based measurement of walking capacity using the GPS technique, through a multicenter study regrouping university hospitals, independent vascular specialists (angiologists) and private clinic(s).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ABI < 0.90 or patients with vascular history (surgery, endovascular treatment) and having vascular type claudication
  • Older than 18 years
  • Vascular-type claudication (defined by the Leriche classification and the Edimbourg questionnaire criterion)
  • Informed consent of the patient

Non-Inclusion Criteria:

  • No informed consent of the patient
  • Exercise (walking) limitation other than vascular explained limitation
  • Critical limb ischemia (Leriche stage 3 or 4)
  • Major cardiovascular events in the last 3 months
  • Pregnant woman
  • Patient unable to understand the protocol of the study

Exclusion criteria

  • Withdrawal of the informed consent of the patient following the inclusion period
  • Emergence of a non-inclusion criteria during the inclusion period
  • Patient with a GPS maximal walking distance > 2000 meters following the first evaluation (can not be considered as having a major walking limitation)

Treatment and study plan

GPS recording(s) of walking capacity in PAD patients

Procedure

Home-based GPS recording(s) of walking capacity in PAD patients. Two evaluations will be performed. The second evaluation will be performed six months after the initial assessment (test 1) and only for patients with GPS maximal walking distance below 2000 meters at test 1. It is expected that some patients at test 2 will have undergo surgery or endovascular treatment.

Other names: Ambulatory technique, Clinical routine

Primary outcomes

  1. Percentage of home-based GPS recordings that are analyzable

    Time frame: December 2011

Secondary outcomes

  1. "Technical quality" of recorded GPS signals

    Time frame: December 2011

  2. Easiness of the interpretation of the GPS measurements

    Time frame: December 2011

  3. Adherence of the patients to the protocol

    Time frame: December 2011

  4. Compare GPS results to the results obtained with different questionnaires (external validity)

    Time frame: December 2011

    The questionnaires used assess the physical activity level, the quality of life and the walking impairment of the studied PAD patients.

  5. Sensibility of GPS measurements after (or not) a therapeutic treatment (endovascular treatment, surgery)

    Time frame: December 2011

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Collaborators

  • Région des Pays de la Loire

Registry information

Official study title

Feasibility of Home-based Measurement of Walking Capacity Using Global Positioning System in Patients With Peripheral Arterial Disease

Acronym: POST-GPS

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jun 10, 2010
Registry last updated
Mar 18, 2013

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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