Clinical trial NCT06998498: Prehabilitation for Aortic Aneurysm Surgery: Proof-of-concept Trial
Official title: Prehabilitation for Aortic Aneurysm Surgery: Proof-of-concept Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aortic Aneurysm
Keywords: Aortic aneurysm
Prehabilitation
Collaborative care
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Intervention feasibility
timeFrame: Weekly over 6 weeks
Secondary outcomes:
measure: Feasibility of data collection
timeFrame: Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge
measure: Utility of the Ready for Recovery program
timeFrame: 6 weeks
measure: Change in physical function (PROMIS PF-20)
timeFrame: Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge
Other outcomes:
measure: Change in physical health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] physical component score)
timeFrame: Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge
measure: Change in mental health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] mental component score)
timeFrame: Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge
measure: Change in depressive symptoms (9-item Patient Health Questionnaire [PHQ-9])
timeFrame: Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge
measure: Change in anxiety symptoms (7-item Generalized Anxiety Disorder Scale [GAD-7])
timeFrame: Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge
measure: Change in perceived stress (Perceived Stress Scale)
timeFrame: Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge
measure: Change in cognition (telephonic Montreal Cognitive Assessment [t-MoCA])
timeFrame: Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge
measure: Change in perceived social support (Multidimensional Scale of Perceived Social Support)
timeFrame: Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge
measure: Change in self-reported physical activity (International Physical Activity Questionnaire [IPAQ]; in metabolic equivalent-minutes/week)
timeFrame: Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge
measure: Changes in cigarette smoking (in number of cigarettes smoked per week)
timeFrame: Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Christopher M Celano, M.D.
role: PRINCIPAL_INVESTIGATOR
References: