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Optimized Supervised Education Program for Peripheral Arterial Disease (POPART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01065740
Recruitment Status : Terminated (Recruitment Difficulties and Financing Limited and exhausted)
First Posted : February 9, 2010
Last Update Posted : June 27, 2016
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:
Peripheral arterial disease (PAD) is a frequent and serious chronic disease witch is undertreated. The recommended management of PAD include pharmacological approach and lifestyle modifications. Patient education help to reach this outcome. Our study propose to compare patient education management with physical activity coaching to usual care.

Condition or disease Intervention/treatment
Peripheral Arterial Disease Other: Patient education

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimized Supervised Education Program for Peripheral Arterial Disease: Ambulatory Management With Patient Education
Study Start Date : February 2010
Primary Completion Date : February 2015
Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: patient education
individual and group meetings with explanations about the disease, lifestyle counseling ; coaching by phone at 1 and 4 months; medical consultation at 3 months; physical exercise with coaching
Other: Patient education
No Intervention: Usual care



Primary Outcome Measures :
  1. 6 minutes walking test [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18 to 75 years
  • With peripheral arterial disease
  • Who accept to follow a patient education program

Exclusion Criteria:

  • Permanent limb ischemia
  • Revascularisation programmed in the 6 next months
  • Other severe prognostic disease
  • Difficulties to obtain patient consent because of language or understanding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065740


Locations
France
Rennes University Hospital
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01065740     History of Changes
Other Study ID Numbers: phrq/09-01
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: June 27, 2016
Last Verified: June 2016

Keywords provided by Rennes University Hospital:
Peripheral arterial disease
Patient education
Physical activity coaching
Lifestyle modifications
Walking capacity
6 minutes walking test

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases