POWER
Research type
Research Study
Full title
POWER - PrehabilitatiOn Workshop and mentored Exercise programme in patients having elective aortic aneurysm Repair
IRAS ID
241950
Contact name
Heena Bidd
Contact email
Sponsor organisation
Guy's and St. Thomas' NHS Foundation Trust
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Summary of Research
Prehabilitation refers to the process of improving a patients’ fitness prior to surgery and generally includes a structured exercise programme along with nutritional and lifestyle advice. Prehabilitation is part of ‘enhanced recovery’ and may help to optimise the health of patients before surgery. We are proposing an innovative method of delivering a mentored "home-based" prehabilitation programme, after attending a group workshop, for patients awaiting elective aortic aneurysm surgery.
At Guy's and St Thomas' Hospital, our team of physiotherapists and anaesthetists currently run prehabilitation workshops for patients having elective aortic aneurysm surgery, which patients and their relatives find useful and informative. This, however, is not yet standard practice and available to all aortic aneurysm patients.
This study will aim to assess the feasibility of a mentored home-based programme with our patient population, it will also help to lay the ground work for a future large-scale trial. Furthermore, if we can establish that a home-based programme is possible and that it can lead to improved patient outcomes following Aortic Aneurysm repair, then this would have a significant impact on the peri-operative management of this patient population, overall service improvement and incorporation of prehabilitation as a standard of care.
Summary of Results
The main objectives of the study were related to the feasibility of running a full trial and hence not fully powered. The following results demonstrate a success in being able to recruit and adhere to the study protocols.
The secondary outcomes, however, were not shown to be statistically significant.
Screening, Recruitment, Withdrawal and Follow-up A total of 60 patients were screened for enrolment into the study.
Of these, 45 patients were enrolled into the study, and randomised into the three study arms (Fig. 1).
A total of 22 patients were withdrawn from the study. The median (IQR) interval between patient recruitment and withdrawal from the study for these patients was 35.5 (27 to 260).Outcomes
Primary Outcomes
Feasibility of screening and recruitment Between 2019-12-20 and 2022-11-23, 60 patients were screened for eligibility to participated in the study. Of these, 45 patients (75%) were recruited and randomised, and 43 patients (71.7%) were included for intention to treat analysis.
Subject retention and adherence to wearing activity tracker, 8-week follow-up and blinding Activity tracker data were collected weekly for each subject and missing data was present for 92 out of 344 subject-weeks (26.7%). On weeks when activity tracker data were missing, it was assumed that patients either did not wear the tracker for the entire week, or that the activity tracker failed.
23/43 (53.5%) patients had complete data available (i.e. there was data recorded every week for 8 weeks) from their activity tracker available to assess adherence. The median(IQR) duration that the activity tracker was worn by these patients was 78,581 (75,998 to 80,032) mins over the 8 weeks, representing 97.4% (94.2% to 99.2%) of the time.
40/43 (93.0%) patients attended the 8-week follow-up appointment. All patients who recorded data every week of this 8-week period attended the 8-week follow-up appointment.
Patients were not blinded to their treatment group. However, independent assessors performing functional assessments and Quality of Life assessments at the scheduled 8 week follow-up visit were blinded to patient treatment group assignments. All independent assessors successfully maintained blinding throughout the study.
Activity counts
The activity counts were summed for each patient over the 8-week period, and on weeks where the activity tracker data was unavailable, it was assumed that the activity count that week was zero according to an intention to treat analysis. The median(IQR) activity count was 5,772,748 (3,214,105 to 8,339,418) across all patients. There was no statistically significant difference in activity counts across all arms of the study.
Secondary Outcomes
Incidence of postoperative complications The incidence of postoperative complications in the intention to treat cohort was 5/43 (11.1%) and 2/23 (8.7%) in the per protocol cohort. The sample size in this study is small, and therefore confidence intervals for these point estimate odds ratios are large. This study is underpowered to detect any differences in the incidences of postoperative complications between intervention groups.
Mortality at 30 days
There were no deaths within 30 days of surgery.
There were no statistically significant differences between the groups when examining length hospital stay or quality of life.
Tests of activity and function
Patients’ function was evaluated using the Duke Activity Status Index (DASI), Time Up and Go (TUAG), gait speed and leg muscle strength.There were no statistically significant differences demonstrated between the groups in terms of functional activity.
REC name
London - Central Research Ethics Committee
REC reference
19/LO/0988
Date of REC Opinion
15 Aug 2019
REC opinion
Further Information Favourable Opinion