Study Stopped
Transfer of main study team to another institution
Prehabilitation for Aortic Repair Patients
PREPARE
Does Prehabilitation Prior to Thoracic Aortic Repair Improve Quality of Care?
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 15, 2016
CompletedFirst Posted
Study publicly available on registry
May 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedJanuary 24, 2022
January 1, 2022
4.7 years
April 15, 2016
January 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Feasibility of recruiting and enrolling
We will measure feasibility according to whether we are able to recruit and enroll subjects.
1 year
Secondary Outcomes (1)
Acceptability
1 year
Study Arms (2)
Prehabilitation
EXPERIMENTALParticipants 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.
Usual Care
NO INTERVENTIONParticipants will follow the pre-operative instructions provided by their surgical team.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bo Yang, MD
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Surgery
Study Record Dates
First Submitted
April 15, 2016
First Posted
May 10, 2016
Study Start
February 1, 2016
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
January 24, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share