NCT04169217: POWER

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

Completed NA Last updated 14 February 2024

What this trial tests

NA trial testing Prehabilitation in Vascular Surgery in 45 participants. Completed in 2 February 2023.

Timeline

15 November 2019

Primary endpoint
2 February 2023

2 February 2023

Quick facts

Lead sponsor	Guy's and St Thomas' NHS Foundation Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	single
Primary purpose	supportive care
Enrollment	45
Start date	15 November 2019
Primary completion	2 February 2023
Estimated completion	2 February 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

• Prehabilitation

Conditions studied

• Vascular Surgery — all drugs for Vascular Surgery →

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Who can join

18 and older, any sex, with Vascular Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prehabilitation exercise therapy before elective abdominal aortic aneurysm repair.
   Fenton C, Tan AR, Abaraogu UO, McCaslin JE. · · 2021 · cited 21× · PMID 34236703 · DOI 10.1002/14651858.cd013662.pub2
2. Mentored multimodal prehabilitation for aortic aneurysm surgery: a pilot randomised controlled trial.
   Bidd H, Wong DJN, Colville G, Banugo P, et al · · 2025 · PMID 41275253 · DOI 10.1186/s13741-025-00625-6
3. Mentored multimodal prehabilitation for aortic aneurysm surgery: a pilot randomised controlled trial
   Bidd H, Wong D, Colville G, Banugo P, et al · · 2024 · DOI 10.21203/rs.3.rs-5381792/v1