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

This study has been completed.
Sponsor:
Collaborator:
Oslo University College
Information provided by (Responsible Party):
Elisabeth Bø, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01109732
First received: April 21, 2010
Last updated: November 1, 2016
Last verified: November 2016
  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 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 ]

Enrollment: 50
Study Start Date: February 2010
Study Completion Date: July 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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

Locations
Norway
Oslo University Hospital
Oslo, Norway, 0514
Sponsors and Collaborators
Oslo University Hospital
Oslo University College
Investigators
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 
Study First Received: April 21, 2010
Last Updated: November 1, 2016
Health Authority: Norway: Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on December 09, 2016