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Prehabilitation for Aortic Repair Patients (PREPARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02767518
Recruitment Status : Recruiting
First Posted : May 10, 2016
Last Update Posted : December 19, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Bo Yang, University of Michigan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm Behavioral: Prehabilitation Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Does Prehabilitation Prior to Thoracic Aortic Repair Improve Quality of Care?
Actual Study Start Date : February 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.
Other Name: MSHOP - Michigan Surgical & Health Optimization Program

No Intervention: Usual Care
Participants will follow the pre-operative instructions provided by their surgical team.



Primary Outcome Measures :
  1. Feasibility of recruiting and enrolling [ Time Frame: 1 year ]
    We will measure feasibility according to whether we are able to recruit and enroll subjects.


Secondary Outcome Measures :
  1. Acceptability [ Time Frame: 1 year ]
    We will ask patients to describe their experiences with the prehab program.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02767518


Contacts
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Contact: Elise Woznicki 734-998-2471 elisew@med.umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Angela Lyden, MS    734-232-0484    alyden@med.umich.edu   
Principal Investigator: Elizabeth A. Jackson, MD MPH FACC         
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Bo Yang, MD University of Michigan
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Responsible Party: Dr. Bo Yang, Associate Professor of Surgery, University of Michigan
ClinicalTrials.gov Identifier: NCT02767518    
Other Study ID Numbers: HUM00109521
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: December 19, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases