Abdominal Aortic AneurysmVPARNCT06830967
Virtual Prehabilitation for Patients Undergoing Abdominal Aortic Aneurysm Repair
A study testing Prehabilitation, Exercise therapy and Smoking cessation counselling in people with Abdominal Aortic Aneurysm and Prehabilitation, run by Nova Scotia Health Authority.
Trial summary
The time between diagnosis and operative intervention represents an untapped opportunity to optimize patient readiness for surgery and augment their function prior to undergoing a physiological stress, rather than purely recovering post-operatively. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Prehabilitation, AAA - Abdominal Aortic Aneurysm
- What is being tested?
- Prehabilitation, Exercise therapy and Smoking cessation counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 31 Dec 2026
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants older than 50 years of age awaiting elective open AAA repair with AAA diameter ≤6.9cm at the Halifax Infirmary Hospital between January 2025-December 2025. Participants must have the ability to give individual informed consent.
Who cannot join
- Participants undergoing thoracic, thoracoabdominal and/or perivisceral AAA repair.
- Participants with ruptured or symptomatic AAA.
- Participants with AAA maximal diameter ≥7cm.
- Physical inability to exercise: severe osteoarthritis, musculoskeletal or neurological impairment that precludes exercise.
- Contraindication to exercise: rest systolic blood pressure ≥ 180 mmHg and/or diastolic ≥ 100 mmHg, uncontrolled atrial or ventricular arrythmias or proven exercise induced arrhythmias, unstable angina, unstable or acute heart failure, severe symptomatic valvular stenosis, dynamic left ventricular outflow tract obstruction or other comorbidities that imply clinical instability.
- Inability to have a support person present during exercise therapy.
- Cognitive impairment that would impede understanding of study procedures or informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The time between diagnosis and operative intervention represents an untapped opportunity to optimize patient readiness for surgery and augment their function prior to undergoing a physiological stress, rather than purely recovering post-operatively. Vascular surgery patients are frail and primed to benefit from such interventions and upcoming surgery is a strong motivator for behavioral change. In this proposal, the investigators outline our vision for a prehabilitation program for patients undergoing elective open aortic aneurysm repair (AAA).
Participants scheduled to undergo AAA repair would receive, in addition to standard of care, 5 main interventions: exercise therapy; smoking cessation counseling and pharmacotherapy; nutritional counseling; psychological readiness planning and patient education. Exercise therapy will consist of 6 weeks of moderate exercise coordinated remotely through the cardiology rehabilitation program, whereas all other interventions will be consultations through videoconferencing or phone interactions. Outcomes of interest include morbidity, mortality, predictors of completion of program, exercise function and quality of life.
This study is a pilot feasibility project and the first step in the creation of a long-term program that will improve patient clinical outcomes, exercise capacity quality of life and hopefully become an model for prehabilitation for other institutions across the country and raise the standard of care for vascular surgery patients.
Read the detailed description
The time between diagnosis and operative intervention represents an untapped opportunity to optimize patient readiness for surgery and augment their function prior to undergoing a physiological stress, rather than purely recovering post-operatively. Vascular surgery patients are frail and primed to benefit from such interventions and upcoming surgery is a strong motivator for behavioral change. In this proposal, the investigators outline our vision for a prehabilitation program for patients undergoing elective open aortic aneurysm repair (AAA).
Participants scheduled to undergo AAA repair would receive, in addition to standard of care, 5 main interventions: exercise therapy; smoking cessation counseling and pharmacotherapy; nutritional counseling; psychological readiness planning and patient education. Exercise therapy will consist of 6 weeks of prescribed moderate exercise coordinated remotely through the physiotherapy. Smoking cessation will consist of motivational interview with adjunctive pharmacotherapy prescribed as required. Nutritional assessment will be remotely coordinated with a certified dietician and psychological readiness and patient education will consist of 2 1 hour sessions with a counselor. Outcomes of interest include morbidity, mortality, predictors of completion of program, exercise function and quality of life.
This study is a pilot feasibility project and the first step in the creation of a long-term program that will improve patient clinical outcomes, exercise capacity quality of life and hopefully become an model for prehabilitation for other institutions across the country and raise the standard of care for vascular surgery patients.
- Being tested
- Prehabilitation, Exercise therapy, Smoking cessation counselling, Nutritional counselling, Psychological intervention
- Keywords
- AAA, prehabilitation, abdominal aortic aneurysm
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
Prehabilitation will consist of exercise therapy, smoking cessation, nutritional counselling, psychological intervention and patient education.
Exercise therapyBehavioural
Exercise therapy will consist of tailored 6-week prescribed exercise program consisting of 150-minutes of moderate-vigorous exercise weekly based on patient-to-patient resource availability (eg. neighborhood walk, body-weight exercises). It will target moderate intensity (11-13 on the Borg Rating of perceived exertion scale) and will be adjusted throughout the program as required. It will target aerobic, strength and inspiratory muscle training (IMT). Participants will receive a logbook where the exercise specialist will prescribe the intensity, type, time, and frequency of aerobic, strength and IMT exercises. Each time the participant performs the prescribed home-based exercises they will register their activity in the logbook provided. Exercise specialist will review the logbook every week and will adjust the home-based exercise plan accordingly to ensure both safety and exercise progression.
Smoking cessation counsellingBehavioural
Smoking cessation will be provided through motivational interviewing with a counselor who will assess participant's smoking status, willingness and readiness to quit and provide prescriptions for nicotine replacement therapy in combination with non-nicotinic pharmacotherapy (Varenicline, Buprorprion) as appropriate
Nutritional counsellingBehavioural
Nutritional counseling will be provided through consultation with a registered dietician. Participants will be educated on correct portion sizes, building a balanced plate, learning sources and importance of protein, importance of timing and spacing of meals, along with practicing mindful eating. Promotion and encouragement of dietary changes to ensure balanced intake with adequate protein, weight management, and the regulation of blood glucose will be discussed. Possible barriers to attain the proposed dietary changes and ways to overcome them will also be discussed along with the importance of perioperative nutrition. Based on estimated habitual protein intake, participants will receive a tailored dietary advice aiming a total protein intake of 1,2-1,5g /kg daily, unless contraindicated. Also, participants will be recommended to evenly 'spread' their protein intake over 3 meals with a minimum of 25-30 gram of protein/ meal.
Psychological interventionBehavioural
Participants will receive one hourly session of psychological intervention called "surgical stress tolerance training" with a trained counselor. In this session the psychosocial specialist will address the patient's anxieties, coping strategies, and post-operative expectations, with the goal of optimizing psychological well-being and ways of coping with surgery. The importance of the patient's active participation in the preparation for surgery and healing process will also be discussed. All participants will be given instructions on relaxation and deep breathing techniques.
Patient EducationBehavioural
Patient education will be provided through virtual consultations with a vascular surgery nurse practitioner. These consultations will describe to the patient their journey pre and post-operatively, what to expect and what they are likely to experience, both physically and emotionally. These consultations will also ensure participants have a support person at home available for supervision during prehabilitation and available during their recovery. Additionally, they will ensure that their home is organized for their discharge from hospital and if required, an occupational therapy home consultation may be organized.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation arm | Experimental | Participants in the intervention arm will receive a prehabilitation bundle between the time of diagnosis of abdominal aortic aneurysm and open surgical repair. The prehabilitation bundle will consist of 5 main interventions: exercise therapy; smoking cessation counseling and pharmacotherapy; nutritional counseling; psychological readiness planning and patient education. Exercise therapy will consist of 6 weeks of prescribed moderate exercise coordinated remotely through the physiotherapy. Smoking cessation will consist of motivational interview with adjunctive pharmacotherapy prescribed as required. Nutritional assessment will be remotely coordinated with a certified dietician and psychological readiness and patient education will consist of 2 1 hour sessions with a counselor. Receives: Other: Prehabilitation; Behavioral: Exercise therapy; Behavioral: Smoking cessation counselling; Behavioral: Nutritional counselling; Behavioral: Psychological intervention; Behavioral: Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications measured by the Comprehensive Complication Index (CCI)
The CCI was developed to address some of the limitations of traditional surgical morbidity reporting, such as only reporting the most severe complication or only picking the most common types of complications. It is scored on a true linear interval scale from 0-100 and incorporates the totality of all complications and their severity experienced by a patient
Measured: CCI will be measured from admission to 6 weeks postoperatively
Secondary outcomes (11)
Change in aerobic function
Change in 6 minute walk test. The 6 minute walk test is the maximum distance walked within a 6 minute time frame.
Measured: Measured at baseline, preoperatively and 6 weeks postoperatively
Physical activity
Measured by the Yale physical activity survey (YPAS). The YPAS has 2 sections that provide 3 summary indices and a seasonal adjustment score, all of which are calculated as a recall of physical activity in a typical week in the past month. The range is 0-142, with higher scores suggesting higher physical activity.
Measured: Measured at baseline, preoperatively and 6 weeks postoperatively
Quality of life
The SF 36 measures eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions via survey. The SF 36 range is 0-100, with higher scores indicting higher quality of life.
Measured: Measured at baseline, preoperatively and 6 weeks postoperatively
Anxiety
Anxiety measured by the Hospital Anxiety and Depression questionnaire (HADS) 0 (no anxiety)- 21 (maximal anxiety).
Measured: Measured at baseline, preoperatively and 6 weeks postoperatively
Compliance
Compliance to the different components of the intervention, measured by attendance to supervised sessions (%), adherence to nutritional counseling and supplementation (%), adherence to home-based exercise (%) and adherence to the psychosocial sessions (%)
Measured: Measured from baseline to preoperatively
ICU Length of stay
Intensive Care Unit length of stay
Measured: From admission to 6 weeks postoperatively
Hospital length of stay
Days from admission to discharge from the hospital
Measured: From admission to 6 weeks postoperatively
Reinterventions
Need for surgical reintervention due to surgical complications
Measured: From admission to 6 weeks postoperatively
Readmission
Readmission to the hospital
Measured: at 6 weeks and at 1 year postoperatively
Emergency Room visits
Visits to the emergency room with or without admission to the hospita
Measured: at 6 weeks and at 1 year postoperatively
Mortality
Mortality within 1 year of surgery.
Measured: From admission to 1 year post operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Jessula, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830967
- Sponsor's protocol ID
- 68360
- Acronym
- VPAR
- Status last verified
- Feb 2025
- First submitted
- 29 Jan 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to protect patient privacy.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Prehabilitation for Patients Undergoing Abdominal Aortic Aneurysm Repair
- ClinicalTrials.gov ID
- NCT06830967
- Acronym / sponsor ID
- VPAR / 68360
- Keywords
- AAA, prehabilitation, abdominal aortic aneurysm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Feb 2025 (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.
The time between diagnosis and operative intervention represents an untapped opportunity to optimize patient readiness for surgery and augment their function prior to undergoing a physiological stress, rather than purely recovering post-operatively. Vascular surgery patients are frail and primed to benefit from such interventions and upcoming surgery is a strong motivator for behavioral change. In this proposal, the investigators outline our vision for a prehabilitation program for patients undergoing elective open aortic aneurysm repair (AAA).
Participants scheduled to undergo AAA repair would receive, in addition to standard of care, 5 main interventions: exercise therapy; smoking cessation counseling and pharmacotherapy; nutritional counseling; psychological readiness planning and patient education. Exercise therapy will consist of 6 weeks of moderate exercise coordinated remotely through the cardiology rehabilitation program, whereas all other interventions will be consultations through videoconferencing or phone interactions. Outcomes of interest include morbidity, mortality, predictors of completion of program, exercise function and quality of life.
This study is a pilot feasibility project and the first step in the creation of a long-term program that will improve patient clinical outcomes, exercise capacity quality of life and hopefully become an model for prehabilitation for other institutions across the country and raise the standard of care for vascular surgery patients.
Detailed description
The time between diagnosis and operative intervention represents an untapped opportunity to optimize patient readiness for surgery and augment their function prior to undergoing a physiological stress, rather than purely recovering post-operatively. Vascular surgery patients are frail and primed to benefit from such interventions and upcoming surgery is a strong motivator for behavioral change. In this proposal, the investigators outline our vision for a prehabilitation program for patients undergoing elective open aortic aneurysm repair (AAA).
Participants scheduled to undergo AAA repair would receive, in addition to standard of care, 5 main interventions: exercise therapy; smoking cessation counseling and pharmacotherapy; nutritional counseling; psychological readiness planning and patient education. Exercise therapy will consist of 6 weeks of prescribed moderate exercise coordinated remotely through the physiotherapy. Smoking cessation will consist of motivational interview with adjunctive pharmacotherapy prescribed as required. Nutritional assessment will be remotely coordinated with a certified dietician and psychological readiness and patient education will consist of 2 1 hour sessions with a counselor. Outcomes of interest include morbidity, mortality, predictors of completion of program, exercise function and quality of life.
This study is a pilot feasibility project and the first step in the creation of a long-term program that will improve patient clinical outcomes, exercise capacity quality of life and hopefully become an model for prehabilitation for other institutions across the country and raise the standard of care for vascular surgery patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation arm | Experimental | Other: Prehabilitation, Behavioral: Exercise therapy, Behavioral: Smoking cessation counselling, Behavioral: Nutritional counselling, Behavioral: Psychological intervention, Behavioral: Patient EducationParticipants in the intervention arm will receive a prehabilitation bundle between the time of diagnosis of abdominal aortic aneurysm and open surgical repair. The prehabilitation bundle will consist of 5 main interventions: exercise therapy; smoking cessation counseling and pharmacotherapy; nutritional counseling; psychological readiness planning and patient education. Exercise therapy will consist of 6 weeks of prescribed moderate exercise coordinated remotely through the physiotherapy. Smoking cessation will consist of motivational interview with adjunctive pharmacotherapy prescribed as required. Nutritional assessment will be remotely coordinated with a certified dietician and psychological readiness and patient education will consist of 2 1 hour sessions with a counselor. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants older than 50 years of age awaiting elective open AAA repair with AAA diameter ≤6.9cm at the Halifax Infirmary Hospital between January 2025-December 2025. Participants must have the ability to give individual informed consent.
Key exclusion criteria (7 listed)
- Participants undergoing thoracic, thoracoabdominal and/or perivisceral AAA repair.
- Participants with ruptured or symptomatic AAA.
- Participants with AAA maximal diameter ≥7cm.
- Physical inability to exercise: severe osteoarthritis, musculoskeletal or neurological impairment that precludes exercise.
- Contraindication to exercise: rest systolic blood pressure ≥ 180 mmHg and/or diastolic ≥ 100 mmHg, uncontrolled atrial or ventricular arrythmias or proven exercise induced arrhythmias, unstable angina, unstable or acute heart failure, severe symptomatic valvular stenosis, dynamic left ventricular outflow tract obstruction or other comorbidities that imply clinical instability.
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 |
|---|---|---|
| PrehabilitationPrehabilitation will consist of exercise therapy, smoking cessation, nutritional counselling, psychological intervention and patient education. | Other | Prehabilitation arm |
| Exercise therapyExercise therapy will consist of tailored 6-week prescribed exercise program consisting of 150-minutes of moderate-vigorous exercise weekly based on patient-to-patient resource availability (eg. neighborhood walk, body-weight exercises). It will target moderate intensity (11-13 on the Borg Rating of perceived exertion scale) and will be adjusted throughout the program as required. It will target aerobic, strength and inspiratory muscle training (IMT). Participants will receive a logbook where the exercise specialist will prescribe the intensity, type, time, and frequency of aerobic, strength and IMT exercises. Each time the participant performs the prescribed home-based exercises they will register their activity in the logbook provided. Exercise specialist will review the logbook every week and will adjust the home-based exercise plan accordingly to ensure both safety and exercise progression. | Behavioural | Prehabilitation arm |
| Smoking cessation counsellingSmoking cessation will be provided through motivational interviewing with a counselor who will assess participant's smoking status, willingness and readiness to quit and provide prescriptions for nicotine replacement therapy in combination with non-nicotinic pharmacotherapy (Varenicline, Buprorprion) as appropriate | Behavioural | Prehabilitation arm |
| Nutritional counsellingNutritional counseling will be provided through consultation with a registered dietician. Participants will be educated on correct portion sizes, building a balanced plate, learning sources and importance of protein, importance of timing and spacing of meals, along with practicing mindful eating. Promotion and encouragement of dietary changes to ensure balanced intake with adequate protein, weight management, and the regulation of blood glucose will be discussed. Possible barriers to attain the proposed dietary changes and ways to overcome them will also be discussed along with the importance of perioperative nutrition. Based on estimated habitual protein intake, participants will receive a tailored dietary advice aiming a total protein intake of 1,2-1,5g /kg daily, unless contraindicated. Also, participants will be recommended to evenly 'spread' their protein intake over 3 meals with a minimum of 25-30 gram of protein/ meal. | Behavioural | Prehabilitation arm |
| Psychological interventionParticipants will receive one hourly session of psychological intervention called "surgical stress tolerance training" with a trained counselor. In this session the psychosocial specialist will address the patient's anxieties, coping strategies, and post-operative expectations, with the goal of optimizing psychological well-being and ways of coping with surgery. The importance of the patient's active participation in the preparation for surgery and healing process will also be discussed. All participants will be given instructions on relaxation and deep breathing techniques. | Behavioural | Prehabilitation arm |
| Patient EducationPatient education will be provided through virtual consultations with a vascular surgery nurse practitioner. These consultations will describe to the patient their journey pre and post-operatively, what to expect and what they are likely to experience, both physically and emotionally. These consultations will also ensure participants have a support person at home available for supervision during prehabilitation and available during their recovery. Additionally, they will ensure that their home is organized for their discharge from hospital and if required, an occupational therapy home consultation may be organized. | Behavioural | Prehabilitation arm |
Primary outcome
Postoperative complications measured by the Comprehensive Complication Index (CCI)
Time frame: CCI will be measured from admission to 6 weeks postoperatively
The CCI was developed to address some of the limitations of traditional surgical morbidity reporting, such as only reporting the most severe complication or only picking the most common types of complications. It is scored on a true linear interval scale from 0-100 and incorporates the totality of all complications and their severity experienced by a patient
11 secondary outcomes
Change in aerobic function
Time frame: Measured at baseline, preoperatively and 6 weeks postoperatively
Physical activity
Time frame: Measured at baseline, preoperatively and 6 weeks postoperatively
Quality of life
Time frame: Measured at baseline, preoperatively and 6 weeks postoperatively
Anxiety
Time frame: Measured at baseline, preoperatively and 6 weeks postoperatively
Compliance
Time frame: Measured from baseline to preoperatively
ICU Length of stay
Time frame: From admission to 6 weeks postoperatively
Hospital length of stay
Time frame: From admission to 6 weeks postoperatively
Reinterventions
Time frame: From admission to 6 weeks postoperatively
Readmission
Time frame: at 6 weeks and at 1 year postoperatively
Emergency Room visits
Time frame: at 6 weeks and at 1 year postoperatively
Mortality
Time frame: From admission to 1 year post operatively.
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 17 Feb 2025.
- Individual participant dataSharing planned: No. IPD will not be shared to protect patient privacy.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation, Exercise therapy and Smoking cessation counselling in people with Abdominal Aortic Aneurysm and Prehabilitation, run by Nova Scotia Health Authority.
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 7 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 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Samuel Jessula, MDCM, MSc, FRCSC (1-902-473-3358, samuel.jessula@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications measured by the Comprehensive Complication Index (CCI) (time frame: CCI will be measured from admission to 6 weeks postoperatively). 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 17 Feb 2025.