Prehabilitation for Aortic Aneurysm Surgery: Proof-of-concept Trial

NCT ID: NCT06998498

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-08
• Study Completion Date: 2026-03-31

Brief Summary

This is a single-arm, proof-of-concept trial to examine the feasibility, acceptability, and preliminary efficacy of the Ready for Recovery program, a 6-week collaborative care intervention to help prepare individuals for repair of aortic aneurysms.

Detailed Description

This is a single-arm, proof-of-concept trial to examine the feasibility, acceptability, and preliminary efficacy of the Ready for Recovery program. Ready for Recovery is a 6-week collaborative care program to prepare individuals for surgical procedures to repair an aortic aneurysm. Participants will speak with a study trainer on the phone each week and will set goals related to physical activity, a healthy diet, and inspiratory muscle training. They also will be given resources to reduce stress, treat anxiety and depression (if present), and stop smoking, and the study team will make recommendations regarding medication adjustments to reduce complications after surgery. The primary outcome is feasibility (measured by percentage of phone sessions completed). Secondary outcomes include acceptability (measured by weekly 0-10 utility ratings) and preliminary impact on functional, psychological, and health behavior outcomes.

Conditions

Aortic Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Ready for Recovery

Participants in this arm will receive the Ready for Recovery intervention.

Group Type: EXPERIMENTAL

Ready for Recovery

Intervention Type: BEHAVIORAL

The Ready for Recovery program is a 6-week, multicomponent, tailored, prehabilitation intervention to promote the optimization of medical and psychological status prior to surgery. Its key components include education, enhancement of beneficial health behaviors, reduction of negative psychological symptoms, and the promotion of social support. Following an initial session, the team will develop a customized prehabilitation plan for each participant. Participants will work towards goals each week and will discuss progress with their study trainer via weekly phone sessions, which will continue until the scheduled surgical procedure.

Interventions

Ready for Recovery

The Ready for Recovery program is a 6-week, multicomponent, tailored, prehabilitation intervention to promote the optimization of medical and psychological status prior to surgery. Its key components include education, enhancement of beneficial health behaviors, reduction of negative psychological symptoms, and the promotion of social support. Following an initial session, the team will develop a customized prehabilitation plan for each participant. Participants will work towards goals each week and will discuss progress with their study trainer via weekly phone sessions, which will continue until the scheduled surgical procedure.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adults undergoing elective aortic aneurysm repair (open or endovascular)

Exclusion Criteria

• Cognitive disturbance
• Current pregnancy or plan to become pregnant prior to surgery
• Inability to write/speak fluently in English

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Christopher Celano

Associate Director, Cardiac Psychiatry Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher M Celano, M.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christopher M Celano, M.D.

Role: CONTACT

ccelano@mgh.harvard.edu

617-726-6485

Facility Contacts

Christopher M Celano, M.D.

Role: primary

ccelano@mgh.harvard.edu

617-726-6485

Other Identifiers

2025P001463

Identifier Type: -

Identifier Source: org_study_id