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

NCT01109732 | Completed DMC

• 1 other identifier: 2009/2192-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (1)

• Time to potential occlusion

  1 year

Secondary Outcomes (1)

• 6 Minutes Walk Test

  1 year

Study Arms (2)

Systematic physical training

EXPERIMENTAL

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

Treatment as of today

NO INTERVENTION

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.

Interventions

Systematic physical training with instructor OTHER

Training 3 times per week for 6 months, the first 3 months with an instructor

Systematic physical training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• endovascular treatment on study-leg last 2 years
• other reasons for reduced walking function than peripheral arterial disease

Sponsors & Collaborators

• Oslo University Hospital: lead
• Oslo University College: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, 0514, Norway

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Astrid Bergland, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: April 23, 2010
• Study Start: February 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)