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Completed

NCT Number: NCT04792411

Adherence and Acceptability of a Remote, Home-based, Pre-surgery Programme for Patients Undergoing Abdominal Aortic Aneurysm Surgery

Design A multi-centre pilot study investigating the acceptability and adherence of a prehabilitation on patients requiring abdominal aortic aneurysm repair.

Setting 3 NHS Hospital Vascular Surgery Clinics in the UK.

* Imperial College Healthcare NHS Trust * Cambridge University Hospitals NHS Trust * Mid and South Essex NHS Trust

Patient Population Patients referred to secondary/tertiary vascular clinic for the repair of asymptomatic infrarenal Aneurysm

Intervention:

Baseline (conducted face-to-face): After providing written informed consent, participants will be provided with information about the prehabilitation programme. The following data will also be collected: baseline demographic characteristics (including age, sex and ethnicity), body mass index (BMI), medical history (including time since diagnosis), current medication, aneurysm diameter, health-related quality of life (EQ-5D-5L and EQ-VAS), smoking status and psychological wellbeing (using the Hospital Anxiety and Depression Scale; HADS) and Frailty assessments( QMortality Index, Electronic Frailty Index, Rockall score). Participants will also complete a 6-minute walking test(6MWT).

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College London

London, W68RF, United Kingdom

About this study

Weeks 1 to 5 (conducted remotely via telephone, email or completion of an online survey):

The programme has been developed with experts in the field of sports therapy, physiotherapy and biomechanics, based on robust literature in other fields. The course plan is to start with 3 sessions every week for 6 weeks where participants would complete a tailored home exercise programme or until the expected surgical intervention. In the first week of this programme, the patient will receive three sessions with a total of 150 minutes of exercise according to UK Chief Medical Officers' Physical Activity Guidelines. After each week, we will assess patient tolerance to the exercise regime using Borg scale. The researchers will either increase or decrease exercise intensity according to their feedback. The study will also be assessing patients' preference for how and when they would like to exercise.

End of Programme (conducted remotely via telephone, email or completion of an online survey):

Participants will be contacted by a member of the study team for the reassessment of health-related quality of life, psychological wellbeing and smoking status. Participants will also be required to provide their self-reported weight. On admission for surgery, they will be assessed for frailty using frailty score assessments

Post - Operative Morbidity score(POMS) will be assessed during admission ( Day1, Day 3, Day 5, Day 7, etc) after surgery.

Discharge: (conducted either remotely or face to face):

Participants will complete a reassessment of health-related quality of life, disease-specific quality of life, psychological wellbeing and smoking status. Participants will also complete the 6-MWT.

6 weeks post-surgery (conducted remotely or face-to-face): Participants will complete a reassessment of health-related quality of life, disease-specific quality of life, psychological wellbeing and smoking status. Participants will also complete the 6-MWT.

90-days post-surgery (conducted remotely or face-to-face): Participants will complete reassessment of health-related quality of life, disease-specific quality of life, psychological wellbeing and smoking status. Participants will also complete the 6-MWT. Participants will also complete a frailty assessment score (Rockall)

Treatments Standard national and local practice will be followed for the repair of infra-renal aortic aneurysm. Patients will receive any type of repair as decided by the local Vascular Multi-Disciplinary Team.

Primary Outcome Prehabilitation Programme compliance, attendance and acceptability.

Secondary Outcomes

  • In-Hospital Complication Rate - Composite of Cardiac, Respiratory, Renal, Haemorrhage, Limb Ischaemia and Cerebral Complications, as defined by National Vascular Registry
  • Length of stay and readmission rates (30 days post-surgery)
  • 30-day Composite Outcome: Death and Defined complication (Cardiac, respiratory, haemorrhage, limb ischaemia, renal failure)
  • Change in 6-minute walk test (6-MWT) at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
  • Change in health-related quality of life scores (using the EuroQol five-dimensional questionnaire [EQ-5D] and visual analogue scale [EQ-VAS]) at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
  • Post-Operative Morbidity score (POMS)
  • Change in aneurysm specific quality of life scores at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
  • Change in Hospital Anxiety and Depression Score (HADS) at 6-weeks post enrolment and 30 and 90-days post-surgery
  • Reduction in cigarettes per day at 6-weeks post enrolment and 30 and 90-days post-surgery
  • Change in weight (in kg) 6-weeks post enrolment and 30 and 90-days post-surgery

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (aged 55 years and over) who have been diagnosed with an AAA and are scheduled to undergo EVAR or open surgery (with a wait time of at least 6-weeks for surgery).
  • Patients with an AAA with a diameter of 5.5cm to 7cm
  • Able to write, understand and communicate in English
  • Willing and able to participate in a virtual prehabilitation programme

Exclusion criteria

  • Thoraco-Abdominal Aneurysms
  • Connective tissue Vascular Disorder
  • Symptomatic aneurysms
  • Previous Aortic intervention
  • Absolute contraindication to exercise
  • Inability or unwillingness to participate in the trial
  • Infrarenal AAA diameter exceeding 7.0cm
  • Emergency AAA repair
  • BMI below 20 kg/m2 or above 45 kg/m2

Treatment and study plan

Prehabilitation

Behavioral

Multimodal, tailored prehabilitation programme

Primary outcomes

  1. Feasibility of screening and recruitment

    Time frame: 18 months

    The number of participants referred at each site will be captured The number of participants eligible for screening at each site will be captured The number of participants enrolled at each site will be captured Reasons for non-participation will be captured

  2. Feasibility of measurement tools:

    Time frame: 18 months

    Time taken to complete the questionnaires at each time-point The ratio of missing data from questionnaires Follow-up response rates

  3. Adherence

    Time frame: at least 6 weeks ( Duration of the programme)

    Number of sessions attended The proportion of participants who complete' the 6-week programme

  4. Acceptability of the prehabilitation programme (Patient satisfaction)

    Time frame: 18 months

    Patient satisfaction will be measured using questionnaires Reasons for drop-out will be captured.

Secondary outcomes

  1. In-Hospital Complication Rate

    Time frame: Immediately after the surgery

    • Composite of Cardiac, Respiratory, Renal, Haemorrhage, Limb Ischaemia and Cerebral Complications, as defined by National Vascular Registry
  2. 30-day(After surgery) Composite Outcome

    Time frame: 30 days

    Incidence of Mortality Incidence of complications

  3. Length of stay and readmission rates (30 days post-surgery)

    Time frame: 30 days

    Reintervention, or areadmission related to repair or other complications

  4. Change in 6-minute walk test (6-MWT) at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)

    Time frame: 6 weeks, 3 months

    To measure the change of patient physical function

  5. Change in health-related quality of life scores (using the EuroQol five-dimensional questionnaire [EQ-5D] and visual analogue scale [EQ-VAS]) at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)

    Time frame: 6 weeks, 3 months

    Participants quality of life measure throughout the study

  6. Post-Operative Morbidity score (POMS)

    Time frame: Immediately after surgery

    To measure post operative complications and it's impact on participants

  7. Change in aneurysm specific quality of life scores at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)

    Time frame: 6 weeks, 3 months

    Participants quality of life measure related to aneurysm repair throughout the study

  8. Change in Hospital Anxiety and Depression Score (HADS) end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)

    Time frame: 6 weeks, 3 months

    Participants anxiety and depression score change throughout the study 0-7 (Normal) 8-10 (Mild) 11-15 (Moderate) 16-21 (Severe)

  9. Change in cigarettes usage per day

    Time frame: 6 weeks, 3 months

    Difference in cigarettes usage at different phases of the study

  10. Change in weight (in kg) end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)

    Time frame: 6 weeks, 3 months

    Measure weight change

Sponsors and collaborators

Lead sponsor

Imperial College Healthcare NHS Trust

Other

Collaborators

  • Cambridge University Hospitals NHS Foundation Trust
  • Mid and South Essex NHS Foundation Trust

Registry information

Official study title

Multi-centre, Pilot Study Evaluating the Feasibility, Acceptability, and Short-term Outcomes of a Tailored, Virtual, Home-based, Multicomponent Prehabilitation Programme in Patients Undergoing Abdominal Aortic Aneurysms (AAA) Repair.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 11, 2021
Registry last updated
Oct 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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