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Active, Not Recruiting

NCT Number: NCT06998498

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Aortic Aneurysm Aneurysm Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02155, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ready for Recovery

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.

Primary outcomes

  1. Intervention feasibility

    Time frame: Weekly over 6 weeks

    Percentage of intervention phone sessions completed

Secondary outcomes

  1. Feasibility of data collection

    Time frame: Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge

    Proportion of assessment sessions in which outcome data is obtained from participants and the medical record

  2. Utility of the Ready for Recovery program

    Time frame: 6 weeks

    Participants will rate the utility of the Ready for Recovery program on an 11-point Likert scale (0-10), with 0 being not at all helpful and 10 being very helpful.

  3. Change in physical function (PROMIS PF-20)

    Time frame: Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge

    Physical function will be measured using the 20-item PROMIS Physical Function Scale (PROMIS PF-20). PROMIS PF-20 scores range from 20 to 100, with higher scores indicating higher levels of physical function.

Other outcomes

  1. Change in physical health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] physical component score)

    Time frame: Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge

    The SF-12 physical component score will be used to assess physical health-related quality of life (Range: 0-100). Higher scores indicate higher levels of physical health-related quality of life.

  2. Change in mental health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] mental component score)

    Time frame: Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge

    The SF-12 mental component score will be used to assess mental health-related quality of life (Range: 0-100). Higher scores indicate higher levels of mental health-related quality of life.

  3. Change in depressive symptoms (9-item Patient Health Questionnaire [PHQ-9])

    Time frame: Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge

    Depressive symptoms will be measured using the 9-item Patient Health Questionnaire (PHQ-9). The PHQ-9 ranges from 0-27, with higher scores indicating higher levels of depression.

  4. Change in anxiety symptoms (7-item Generalized Anxiety Disorder Scale [GAD-7])

    Time frame: Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge

    Anxiety will be measured using the 7-item Generalized Anxiety Disorder scale (GAD-7). The GAD-7 ranges from 0-21, with higher scores indicating higher levels of anxiety

  5. Change in perceived stress (Perceived Stress Scale)

    Time frame: Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge

    Perceived stress will be assessed via the Perceived Stress Scale (PSS). PSS scores range from 0-40, with higher scores indicating higher levels of perceived stress.

  6. Change in cognition (telephonic Montreal Cognitive Assessment [t-MoCA])

    Time frame: Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge

    Cognition will be measured using the telphonic Montreal Cognitive Assessment (t-MoCA). t-MoCA scores range from 0 to 22, with higher scores indicating better cognition.

  7. Change in perceived social support (Multidimensional Scale of Perceived Social Support)

    Time frame: Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge

    Perceived social support will be measured by the Multidimensional Scale of Perceived Social Support (MSPSS). MSPSS scores range from 1-7, with higher scores indicating higher levels of perceived social support.

  8. Change in self-reported physical activity (International Physical Activity Questionnaire [IPAQ]; in metabolic equivalent-minutes/week)

    Time frame: Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge

    This will be measured via the International Physical Activity Questionnaire (IPAQ) as a secondary measure of physical activity.

  9. Changes in cigarette smoking (in number of cigarettes smoked per week)

    Time frame: Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge

    Participants will be asked how many cigarettes they have smoked in the past week.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 31, 2025
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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