Prehabilitation for Aortic Repair Patients

Aortic Aneurysm Clinical Trial

— PREPARE  

Official title:

Does Prehabilitation Prior to Thoracic Aortic Repair Improve Quality of Care?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02767518
• Other study ID #: HUM00109521
• Status: Terminated
• Phase: N/A
• Start date: February 2016
• Est. completion date: October 2020

Study information

• Verified date: January 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruiting and enrolling	We will measure feasibility according to whether we are able to recruit and enroll subjects.	1 year
Secondary	Acceptability	We will ask patients to describe their experiences with the prehab program.	1 year