NCT04169217

Brief 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:

  • 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:
  • Screening and recruitment
  • Retention, blinding and follow up procedures.
  • Adherence
  • Composite of post-operative cardiac, respiratory and renal complications at 30 days
  • Mortality at 30 days following surgery.
  • Length of postoperative hospital stay
  • Quality of life (EQ-5DL)- post surgery.
  • Tests of activity and function

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

November 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2023

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

3.2 years

First QC Date

September 3, 2019

Last Update Submit

February 12, 2024

Conditions

Vascular Surgery

Keywords

Prehabilitation

Outcome Measures

Primary Outcomes (3)

  • Feasibility of screening and recruitment: recruitment ratio

    Screening: recruitment ratio of 3:1

    18 months

  • Subject retention and adherence to 8-week follow up and blinding

    Subject wearing activity tracker for greater than 80% of the time, 80% or more attendance to 8-week follow up \* and 80% or more maintenance of blinding. \*COVID PANDEMIC ADJUSTMENT: 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

    8 weeks

  • Adherence to trial protocol by comparing weekly physical activity between the three trial groups.

    Increase in activity in intervention groups of 30% or more compared to the control group as measured by the actiwatch

    18 months

Secondary Outcomes (10)

  • Composite of post-operative cardiac complications at 30 days

    30 days post surgery.

  • Composite of post-operative respiratory complications at 30 days

    30 days post surgery

  • Composite of post-operative renal complications at 30 days

    30 days post surgery

  • Mortality at 30 days

    30 days post surgery

  • Length of hospital stay

    18 months

  • +5 more secondary outcomes

Study Arms (3)

Control arm

NO INTERVENTION

This arm will not be in the prehabilitation group- as is current standard practice

Group 2

ACTIVE COMPARATOR

This arm will be subject to a one off prehabilitation workshop and provided with a prehab booklet

Behavioral: Prehabilitation

Group 3- Mentored group

EXPERIMENTAL

This arm will be subject to a one off workshop and provided with a prehab booklet- and additional mentoring by means of 1. an educational app, 2. push notifications,3. weekly communication with physiotherapy team member.

Behavioral: Prehabilitation

Interventions

PrehabilitationBEHAVIORAL

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.

Group 2Group 3- Mentored group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Attending GSTT for aortic aneurysm surgery
  • Ability to walk (determined by ability to perform gait speed independently)
  • Willingness to wear the activity tracker for 8 weeks.
  • Willingness to return at 8 weeks for re-assessment of secondary outcome 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

You may not qualify if:

  • Urgent or emergency aneurysm repair
  • Patients who undergo emergency admission during the 8-week time frame, will be removed from the ongoing trial, but their data will be used up to that point.
  • Contraindications to exercise (doesn't apply for short term illness ( appendix 4).
  • Severe musculoskeletal disorders preventing exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7RT, United Kingdom

Location

Related Publications (1)

  • Bidd H, Wong DJN, Colville G, Banugo P, Baldwin M, Waring H, Zucco L, Radcliife G, Zayed H, El-Boghdadly K. Mentored multimodal prehabilitation for aortic aneurysm surgery: a pilot randomised controlled trial. Perioper Med (Lond). 2025 Nov 22;14(1):132. doi: 10.1186/s13741-025-00625-6.

    PMID: 41275253DERIVED

MeSH Terms

Interventions

Preoperative Exercise

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Heena Bidd

    Guys & St Thomas' NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2019

First Posted

November 19, 2019

Study Start

November 15, 2019

Primary Completion

February 2, 2023

Study Completion

February 2, 2023

Last Updated

February 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)