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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Oslo University College
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01109732
First received: April 21, 2010
Last updated: August 23, 2011
Last verified: August 2011
  Purpose

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 Intervention
Peripheral Vascular Disease
Other: Systematic physical training with instructor

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physical Activity, Function and Quality of Life in Older Patients After Endovascular Treatment

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Time to potential occlusion [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 6 Minutes Walk Test [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: February 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Systematic physical training 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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109732

Contacts
Contact: Elisabeth Bø, MSc 004793066490 elisabeth.bo@hf.hio.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0514
Contact: Elisabeth Bø    93066490    elisabeth.bo@hf.hio.no   
Sponsors and Collaborators
Oslo University Hospital
Oslo University College
Investigators
Principal Investigator: Astrid Bergland, PhD Oslo University Hospital
  More Information

No publications provided

Responsible Party: Oslo University College
ClinicalTrials.gov Identifier: NCT01109732     History of Changes
Other Study ID Numbers: 2009/2192-1
Study First Received: April 21, 2010
Last Updated: August 23, 2011
Health Authority: Norway: Ethics Committee

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

ClinicalTrials.gov processed this record on October 20, 2014