Aortic AneurysmNCT07797504
Ready for Recovery Pilot Trial
A study testing Ready for Recovery and Enhanced Ready for Recovery in people with Aortic Aneurysm, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a three-arm, randomized pilot trial to examine the feasibility, acceptability, and preliminary efficacy of two multicomponent interventions to promote recovery from aortic aneurysm repair procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm
- What is being tested?
- Ready for Recovery and Enhanced Ready for Recovery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults undergoing elective aortic aneurysm repair (open or endovascular)
Who cannot join
- Emergent aortic aneurysm repair
- Cognitive disturbance
- Functional impairment significantly impacting the ability to stand or walk
- Current pregnancy or plan to become pregnant prior to surgery
- Inability to write/speak fluently in English
- Lack of access to a phone, computer, or tablet with internet access
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
Christopher M Celano, M.D., 617-726-6485, ccelano@mgh.harvard.edu
About this study
Official title: Prehabilitation for Aortic Aneurysm Surgery: The Ready for Recovery Randomized Pilot Trial
This is a three-arm, randomized pilot trial to examine the feasibility, acceptability, and preliminary efficacy of two multicomponent interventions to promote recovery from aortic aneurysm repair procedures.
Read the detailed description
This is a three-arm, randomized pilot trial to examine the feasibility, acceptability, and preliminary efficacy of two multicomponent programs (Ready for Recovery and an enhanced version of the program) to prepare patients for aortic aneurysm repair and to promote their recovery. 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 enhanced version has an additional four weeks of phone sessions post-surgery, to provide support and guidance during the early recovery period. The control condition will be standard medical care. The primary outcome is feasibility (measured by proportion of 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
- Being tested
- Ready for Recovery, Enhanced Ready for Recovery
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ready for RecoveryBehavioural
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.
Enhanced Ready for RecoveryBehavioural
The enhanced Ready for Recovery program is a 10-week, multicomponent, tailored, prehabilitation intervention to promote recovery from aortic aneurysm repair. 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. Following surgery, participants will engage in four additional weekly sessions to discuss the recovery process and plan for longer-term behavior change.
| Study group | Role | What they receive |
|---|---|---|
| Ready for Recovery | Experimental | Participants in this arm will receive the 6-week Ready for Recovery intervention prior to surgery. Receives: Behavioral: Ready for Recovery |
| Enhanced Ready for Recovery | Experimental | Participants in this arm will receive the 6-week Ready for Recovery intervention prior to surgery, plus an additional 4-week intervention post-surgery. Receives: Behavioral: Enhanced Ready for Recovery |
| Standard Medical Care | No intervention | Participants in this arm will receive standard medical care and no additional interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention feasibility
Percentage of intervention phone sessions completed
Measured: Weekly over 6 weeks (Ready for Recovery group) or 10 weeks (Enhanced Ready for Recovery group)
Secondary outcomes (2)
Intervention Utility
Participants will rate the utility of the Ready for Recovery program or enhanced Ready for Recovery program on an 11-point Likert scale (0-10), with 0 being not at all helpful and 10 being very helpful.
Measured: 6 weeks (Ready for Recovery) or 10 weeks (Enhanced Ready for Recovery)
Change in functional capacity (1 Minute Sit to Stand Test)
Functional capacity will be measured using the 1-minute Sit to Stand Test. Participants will be instructed to stand up and sit back down on an armless chair repeatedly for one minute as quickly as possible. The number of times the participant fully stands and then sits down again will be recorded.
Measured: Baseline, post-intervention (1-5 days prior to surgery), 30 days post-discharge, 90 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm, randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Celano, Massachusetts General Hospital
- Investigators
- Christopher M Celano, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797504
- Sponsor's protocol ID
- 2026P001681
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation for Aortic Aneurysm Surgery: The Ready for Recovery Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT07797504
- Acronym / sponsor ID
- 2026P001681
- Conditions
- Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a three-arm, randomized pilot trial to examine the feasibility, acceptability, and preliminary efficacy of two multicomponent interventions to promote recovery from aortic aneurysm repair procedures.
Detailed description
This is a three-arm, randomized pilot trial to examine the feasibility, acceptability, and preliminary efficacy of two multicomponent programs (Ready for Recovery and an enhanced version of the program) to prepare patients for aortic aneurysm repair and to promote their recovery. 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 enhanced version has an additional four weeks of phone sessions post-surgery, to provide support and guidance during the early recovery period. The control condition will be standard medical care. The primary outcome is feasibility (measured by proportion of sessions completed). Secondary outcomes include acceptability (measured by weekly 0-10 utility ratings) and preliminary impact on functional, psychological, and health behavior outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm, randomized trial
| Arm | Type | Receives |
|---|---|---|
| Ready for Recovery | Experimental | Behavioral: Ready for RecoveryParticipants in this arm will receive the 6-week Ready for Recovery intervention prior to surgery. |
| Enhanced Ready for Recovery | Experimental | Behavioral: Enhanced Ready for RecoveryParticipants in this arm will receive the 6-week Ready for Recovery intervention prior to surgery, plus an additional 4-week intervention post-surgery. |
| Standard Medical Care | No intervention | –Participants in this arm will receive standard medical care and no additional interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults undergoing elective aortic aneurysm repair (open or endovascular)
Key exclusion criteria (6 listed)
- Emergent aortic aneurysm repair
- Cognitive disturbance
- Functional impairment significantly impacting the ability to stand or walk
- Current pregnancy or plan to become pregnant prior to surgery
- Inability to write/speak fluently in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ready for RecoveryThe 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. | Behavioural | Ready for Recovery |
| Enhanced Ready for RecoveryThe enhanced Ready for Recovery program is a 10-week, multicomponent, tailored, prehabilitation intervention to promote recovery from aortic aneurysm repair. 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. Following surgery, participants will engage in four additional weekly sessions to discuss the recovery process and plan for longer-term behavior change. | Behavioural | Enhanced Ready for Recovery |
Primary outcome
Intervention feasibility
Time frame: Weekly over 6 weeks (Ready for Recovery group) or 10 weeks (Enhanced Ready for Recovery group)
Percentage of intervention phone sessions completed
2 secondary outcomes
Intervention Utility
Time frame: 6 weeks (Ready for Recovery) or 10 weeks (Enhanced Ready for Recovery)
Change in functional capacity (1 Minute Sit to Stand Test)
Time frame: Baseline, post-intervention (1-5 days prior to surgery), 30 days post-discharge, 90 days post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher M Celano, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ready for Recovery and Enhanced Ready for Recovery in people with Aortic Aneurysm, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher M Celano, M.D. (617-726-6485, ccelano@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention feasibility (time frame: Weekly over 6 weeks (Ready for Recovery group) or 10 weeks (Enhanced Ready for Recovery group)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.