N/A
N=25
Trimodal Prehabilitation for Aneurysm Surgery Study
Aortic Aneurysm
Bottom Line
View on ClinicalTrials.gov: NCT02292927 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: The Number of Patients Who Accepted Inclusion Into a Pre-operative Prehabilitation Programme — 11 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Post-intervention arm = Prehabilitation (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Patients Who Accepted Inclusion Into a Pre-operative Prehabilitation Programme |
11 | — |
| PRIMARY Change From Baseline in Metabolic Equivalents (METS) at Six Weeks |
0.06 | — |
| PRIMARY Decrease in Anxiety and Depression Scores (Hospital Anxiety and Depression Scale) |
1.2; 5 | — |
| PRIMARY Number of Participants With Attendance at the Physical and Psychological and Social Training Appointments of the Rehabilitation Programme (Assessed by Bespoke Questionnaire) |
11 | — |
| SECONDARY HDU/ITU Resource Use (Number of Days Stay) |
1.75; 2.42 | — |
| SECONDARY LOS |
5.5; 5.14 | — |
Summary
DESIGN: Single-centre, feasibility study AIMS: The aim of this study is to evaluate the acceptability and pre-operative impact on functional capacity of a trimodal prehabilitation program in a cohort of patients undergoing aneurysm repair.
This will enable the design (feasibility and power) of a large scale Randomised Controlled Trial.
Expected outcomes
* The potential number of patients who would benefit, the compliance and acceptability of a pre-operative prehabilitation programme will be calculated.
* Preoperatively, expected at 6-weeks, the change in physical fitness of patients (assessed by the physical function section of SF-36 and measured with peak flow/6-minute walk testing) during the pre-operative phase will be assessed in both groups.
* The effects on quality of life, anxiety and depression on each study participant will be assessed immediately pre-op, expected at 6-weeks.
* The number of patients who are able to reduce or cease smoking will be reported during the pre-op phase (expected at 6 weeks), as will length of hospital stay after aortic surgery, expected at 6-8 weeks.
POPULATION: Patients undergoing planned elective aortic surgery procedures
ELIGIBILITY: Adult patients (over 18 years) undergoing elective open and endovascular aneurysm repair with capacity to consent and physical fitness to undergo an pre-operative exercise programme DURATION: 1 year from 1st June 2014
Eligibility Criteria
Inclusion Criteria
- patients undergoing elective repair, willing/able to undertake a period of prehabilitation, and those able to comprehend and retain instructions regarding self-training.
Exclusion Criteria
- Symptomatic patients or those undergoing urgent treatment (< 2 weeks)
Data sourced from ClinicalTrials.gov (NCT02292927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.