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

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Mass General Brigham

Status

Enrolling

Conditions

Aortic Aneurysm

Treatments

Behavioral: Ready for Recovery

Study type

Interventional

Funder types

Other

Identifiers

NCT06998498
2025P001463

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Ready for Recovery
Experimental group
Description:
Participants in this arm will receive the Ready for Recovery intervention.
Treatment:
Behavioral: Ready for Recovery

Trial contacts and locations

1

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Central trial contact

Christopher M Celano, M.D.

Data sourced from clinicaltrials.gov

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