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Physical Activity, Function and Quality of Life in Patients After Endovascular Treatment

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ClinicalTrials.gov Identifier: NCT01109732
Recruitment Status : Completed
First Posted : April 23, 2010
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to investigate how systematic physical training after endovascular treatment influence the durability of the endovascular treatment and how it effects physical function, quality of life and future cardiovascular events.

Condition or disease Intervention/treatment
Peripheral Vascular Disease Other: Systematic physical training with instructor

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physical Activity, Function and Quality of Life in Patients After Endovascular Treatment
Study Start Date : February 2010
Primary Completion Date : June 2012
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Systematic physical training
Hospital-based SET two days per week for 12 weeks and one home-based exercise session every week. The group-based SET was based on The Norwegian Ullevaal Model, a modified cardiac rehabilitation program, and was slightly adjusted to be applicable to this patient group. Each SET session lasted for 60 minutes and consisted of warm-up exercises, three high-intensity, two moderate-intensity and cool-down exercises, including stretching. The exercises were generally simple aerobic dance movements and walking and involved the use of both upper and lower extremities. The warm-up exercises included large muscle movements that were repeated later in the higher-intensity intervals, but with greater force and a larger range of movement.
Other: Systematic physical training with instructor
Training 3 times per week for 6 months, the first 3 months with an instructor
No Intervention: Treatment as of today
The control group did not receive any additional follow-up regarding exercise at discharge beyond the general advice about the importance of exercise that is routinely provided at the hospital.

Outcome Measures

Primary Outcome Measures :
  1. Time to potential occlusion [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 6 Minutes Walk Test [ Time Frame: 1 year ]

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 55 years old or older
  • successful endovascular
  • living in Oslo or in the close area being able to come to physical training classes at the hospital

Exclusion Criteria:

  • endovascular treatment on study-leg last 2 years
  • other reasons for reduced walking function than peripheral arterial disease
Contacts and Locations

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): NCT01109732

Oslo University Hospital
Oslo, Norway, 0514
Sponsors and Collaborators
Oslo University Hospital
Oslo University College
Principal Investigator: Astrid Bergland, PhD Oslo University Hospital
More Information

Responsible Party: Elisabeth Bø, MSc, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01109732     History of Changes
Other Study ID Numbers: 2009/2192-1
First Posted: April 23, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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