Back to resultsPrehabilitation for Aortic Repair Patients (PREPARE)
Primary Purpose
Aortic Aneurysm
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Aneurysm
Eligibility 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
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Prehabilitation
Usual Care
Arm Description
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.
Participants will follow the pre-operative instructions provided by their surgical team.
Outcomes
Primary Outcome Measures
Feasibility of recruiting and enrolling
We will measure feasibility according to whether we are able to recruit and enroll subjects.
Secondary Outcome Measures
Acceptability
We will ask patients to describe their experiences with the prehab program.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02767518
Brief Title
Prehabilitation for Aortic Repair Patients
Acronym
PREPARE
Official Title
Does Prehabilitation Prior to Thoracic Aortic Repair Improve Quality of Care?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Transfer of main study team to another institution
Study Start Date
February 2016 (Actual)
Primary Completion Date
October 2020 (Actual)
Study Completion Date
October 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants will follow the pre-operative instructions provided by their surgical team.
Intervention Type
Behavioral
Intervention Name(s)
Prehabilitation
Other Intervention Name(s)
MSHOP - Michigan Surgical & Health Optimization Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of recruiting and enrolling
Description
We will measure feasibility according to whether we are able to recruit and enroll subjects.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Acceptability
Description
We will ask patients to describe their experiences with the prehab program.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Yang, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prehabilitation for Aortic Repair Patients
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