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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Vascular Disease
• Intervention / Treatment: Other: Systematic physical training with instructor

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0514
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to potential occlusion	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
6 Minutes Walk Test	1 year

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Oslo University College
• Investigators: Principal Investigator: Astrid Bergland, PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: April 21, 2010
• First Submitted That Met QC Criteria: April 22, 2010
• First Posted (ESTIMATE): April 23, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 2009/2192-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO