search
Back to results

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

Primary Purpose

Peripheral Vascular Disease

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Systematic physical training with instructor
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Vascular Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Systematic physical training

Treatment as of today

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time to potential occlusion

Secondary Outcome Measures

6 Minutes Walk Test

Full Information

First Posted
April 21, 2010
Last Updated
November 1, 2016
Sponsor
Oslo University Hospital
Collaborators
Oslo University College
search

1. Study Identification

Unique Protocol Identification Number
NCT01109732
Brief Title
Physical Activity, Function and Quality of Life in Patients After Endovascular Treatment
Official Title
Physical Activity, Function and Quality of Life in Patients After Endovascular Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Oslo University College

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Systematic physical training
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as of today
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Systematic physical training with instructor
Intervention Description
Training 3 times per week for 6 months, the first 3 months with an instructor
Primary Outcome Measure Information:
Title
Time to potential occlusion
Time Frame
1 year
Secondary Outcome Measure Information:
Title
6 Minutes Walk Test
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astrid Bergland, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0514
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs