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NCT02767518 Clinical Trial

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
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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