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Trimodal Prehabilitation for Aneurysm Surgery Study

NCT02292927 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-07-17

Study results available
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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

Conditions

  • Aortic Aneurysm

Interventions

BEHAVIORAL

Post-intervention arm = Prehabilitation

Introduction of a physical exercise training programme, psychological counselling and smoking cessation advice

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-12-31
Completion
2015-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02292927 on ClinicalTrials.gov