POWER: PrehabilitatiOn Workshop and Mentored Exercise Programme in Patients Having Elective Aortic Aneurysm Repair

Summary

Protocol Short Title:

POWER Study - PrehabilitatiOn Workshop and mentored Exercise programme in patients having elective aortic aneurysm Repair

Population:

Patients scheduled for elective repair of aortic aneurysm at St. Thomas' Hospital

Screening and recruitment:

Eligible participants will be identified by the vascular team; during the weekly multi-disciplinary team meeting, or via the clinical nurse specialist from tertiary referrals.

Participant information leaflets will then be sent out to eligible patients 2 weeks before the outpatient appointment.

Recruitment will be carried out during surgical outpatient appointments. Written informed consent will be obtained and participants will be randomised into three groups.

This pilot study will help us to:

1. To assess feasibility of screening, recruitment and retention
2. To assess adherence to intervention and blinding.
3. To generate outcome data that may be used to power definitive clinical trials

Primary objective To determine the feasibility of delivery of a randomised control trial.

Secondary objective (s) To determine baseline outcome data that may be used to power a randomised control trial.

Number of Subjects/Patients A convenience sample of 15 patients per group is planned, with a total of 45 patients recruited. At GSTT 200-250 aortic aneurysm operations are performed annually. We aim to recruit 40% of those eligible and screened. This would equate to 4-6 recruited per month.

Trial Design Single-blinded, randomised, controlled pilot study.

Patients will be allocated into the following groups:

Control group:

\- Current standard practice, no prehabilitation workshop.

Non-mentored group:

* Prehabilitation workshop with no further patient contact.
* Participants to be given a prehab 'pack' which includes advice and a diary card.

Mentored group:

* Prehabilitation workshop with addition of regular 'mentoring' for up to 8 weeks after the workshop.
* Participants to be given a prehab 'pack' which includes advice and a diary card.

Primary Endpoints:

1. Screening and recruitment
2. Retention, blinding and follow up procedures.
3. Adherence

Secondary Endpoints:

To determine baseline outcome data that may be used to power a randomised control trial by examining the following:

1. Composite of post-operative cardiac, respiratory and renal complications at 30 days
2. Mortality at 30 days following surgery.
3. Length of postoperative hospital stay
4. Quality of life (EQ-5DL)- post surgery.
5. Tests of activity and function

Main Inclusion Criteria

Inclusion:

Elective all aortic aneurysm repair (Willingness to return after 8 weeks for re-assessment of secondary measures) Note: \*COVID PANDEMIC ADJUSTMENT: Since March 2020, 1st national lockdown. Participants are no longer required to attend the 8 week follow up in person. The Quality of life questionnaires are done over the telephone by the research practitioner. The functional assessments are now done when the participant is admitted for their surgery Participants must have an e mail address.

Exclusions:

Urgent or emergency repair Contraindications to exercise (doesn't apply for short term illness) Severe musculoskeletal disorders preventing exercise

Conditions

• Vascular Surgery

Interventions

BEHAVIORAL

Prehabilitation

A combination of a one off workshop and mentored prehabilitation. Covid Pandemic amendment: The workshop was originally a group based face to face patient workshop. This intervention is now (since the first national lockdown in March 2020) a virtual workshop using a the Bluejeans platform.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust

  lead OTHER

Principal Investigators

• Heena Bidd · Guys & St Thomas' NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-11-15

Primary Completion

2023-02-02

Completion

2023-02-02

Countries

• United Kingdom

Study Locations