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

Peripheral Vascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109732
• Other study ID #: 2009/2192-1
• Status: Completed
• Phase: N/A
• First received: April 21, 2010
• Last updated: November 1, 2016
• Start date: February 2010
• Est. completion date: July 2013

Study information

• Verified date: November 2016
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Other:
• Systematic physical training with instructor
Training 3 times per week for 6 months, the first 3 months with an instructor

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Oslo University College

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to potential occlusion		1 year	No
Secondary	6 Minutes Walk Test		1 year	No