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

NCT ID: NCT01109732

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Vascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Systematic physical training with instructor

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Systematic physical training with instructor

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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University College

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Elisabeth Bø

MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Astrid Bergland, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, Oslo County, Norway

Site Status

Countries

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Norway

Other Identifiers

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2009/2192-1

Identifier Type: -

Identifier Source: org_study_id