Prehabilitation for Aortic Repair Patients

NCT ID: NCT02767518

Last Updated: 2022-01-24

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

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2020-10-31

Brief Summary

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This is a 2-group study comparing the effect of a "prehabilitation" program to usual care on quality of life and clinical outcomes in patients undergoing elective repair of their thoracic aorta.

Detailed Description

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Patients undergoing elective repair of their thoracic aortic aneurysm will be randomized to a "prehabilitation" program prior to their surgery or to usual care. The prehabilitation program is self-directed program designed to improve health and quality of life prior to surgery. The program is currently offered to general surgery patients; this study will examine the feasibility and acceptability of such a program in a different patient population.

Conditions

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Aortic Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Prehabilitation

Participants will be referred to the Michigan Surgical \& Health Optimization Program in the month leading up to their surgery. Individuals are encouraged to increase their physical activity, practice stress reduction, and other behaviors associated with good health.

Group Type EXPERIMENTAL

Prehabilitation

Intervention Type BEHAVIORAL

Participants will receive an informational DVD, a pedometer, an incentive spirometer and access to the program website to help promote healthful behaviors and improved well-being in the days leading up to surgery.

Usual Care

Participants will follow the pre-operative instructions provided by their surgical team.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prehabilitation

Participants will receive an informational DVD, a pedometer, an incentive spirometer and access to the program website to help promote healthful behaviors and improved well-being in the days leading up to surgery.

Intervention Type BEHAVIORAL

Other Intervention Names

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MSHOP - Michigan Surgical & Health Optimization Program

Eligibility Criteria

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Inclusion Criteria

* Age 21 years or older
* Diagnosis of thoracic aortic disease with scheduled repair
* Medical clearance from cardiothoracic surgeon
* Ability to provide informed consent
* Regular use of a smartphone or personal computer

Exclusion Criteria

* Conditions that limit walking to a severe degree
* Current participation in regular physical activity program
* Acute aortic dissection
* Recent coronary artery disease events
* Inability to speak and read English
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Dr. Bo Yang

Associate Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bo Yang, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00109521

Identifier Type: -

Identifier Source: org_study_id

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