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Virtual Prehabilitation for Patients Undergoing Abdominal Aortic Aneurysm Repair

ConditionsAbdominal Aortic AneurysmPrehabilitationAAA - Abdominal Aortic Aneurysm
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorNova Scotia Health Authority

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Prehabilitation

    Other intervention

    Prehabilitation will consist of exercise therapy, smoking cessation, nutritional counselling, psychological intervention and patient education.

  • Exercise therapy

    Behavioral

    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 counselling

    Behavioral

    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 counselling

    Behavioral

    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 intervention

    Behavioral

    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 Education

    Behavioral

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Prehabilitation armExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
CCI will be measured from admission to 6 weeks postoperatively

Secondary outcomes

1

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.

Time frame
Measured at baseline, preoperatively and 6 weeks postoperatively
2

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.

Time frame
Measured at baseline, preoperatively and 6 weeks postoperatively
3

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.

Time frame
Measured at baseline, preoperatively and 6 weeks postoperatively
4

Anxiety

Anxiety measured by the Hospital Anxiety and Depression questionnaire (HADS) 0 (no anxiety)- 21 (maximal anxiety).

Time frame
Measured at baseline, preoperatively and 6 weeks postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nova Scotia Health Authority

Lead sponsor

Source ClinicalTrials.gov

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