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Trimodal Prehabilitation for Aneurysm Surgery Study (T-PASS)

Primary Purpose

Aortic Aneurysm

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Post-intervention arm = Prehabilitation
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Aortic Aneurysm

Eligibility Criteria

40 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Pre-intervention

    Post-intervention arm = Prehabilitation

    Arm Description

    Patients treated as standard before intervention

    Introduction of rehabilitation program

    Outcomes

    Primary Outcome Measures

    The Number of Patients Who Accepted Inclusion Into a Pre-operative Prehabilitation Programme
    This describes the number of people within the study who were in the pre-habilitation study arm that accepted and completed the pre-habilitation training
    Change From Baseline in Metabolic Equivalents (METS) at Six Weeks
    • Metabolic equivalent level is a measure of physical fitness. One MET is defined as 3.5 mL 02 uptake/kg per minute which is the resting oxygen uptake in a sitting position. The achieved exercise capacity in METs has been shown to be predictive in older adult population of survival with higher MET levels associated with improved survival," or similar definition that is accurate and appropriate.
    Decrease in Anxiety and Depression Scores (Hospital Anxiety and Depression Scale)
    HADS is a validated questionnaire consisting of 7 statements relating to anxiety and 7 statements relating to depression. Each statement is scored between 0 and 3 giving a total score of up to 21 for each section. A score of 0-7 is assumed to be normal and score greater than this suggestive of a mood disorder
    Number of Participants With Attendance at the Physical and Psychological and Social Training Appointments of the Rehabilitation Programme (Assessed by Bespoke Questionnaire)

    Secondary Outcome Measures

    HDU/ITU Resource Use (Number of Days Stay)
    Observation to power a larger intervention study
    LOS
    Length of hospital stay after aortic surgery (number of days) - Observation to power a larger intervention study

    Full Information

    First Posted
    November 6, 2014
    Last Updated
    May 7, 2019
    Sponsor
    Imperial College London
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02292927
    Brief Title
    Trimodal Prehabilitation for Aneurysm Surgery Study
    Acronym
    T-PASS
    Official Title
    Maximising Recovery to Health Through Trimodal (Bio Psycho Social) Prehabilitation for Aneurysm Surgery Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Imperial College London

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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
    Detailed Description
    Proposed intervention - The introduction of a biopsychosocial intervention before surgery. The physical exercise programme will be a prescribed exercise training twice per week which will be supported by a physical therapist and vascular nurse specialist. A trained clinical psychologist will also deliver a brief psychological intervention based on cognitive behavioural therapy (CBT) techniques in two sessions to modify illness, surgical preparation and rehabilitation beliefs. Lastly patients will be counselled and referred to smoking cessation services as appropriate by the vascular nurse specialist. Baseline information will include patient demographics and medical history, quality of life assessment using SF-36 forms, hospital anxiety and depression scale (HADS) and exercise testing by a standardised 6-minute walk test Information immediately pre-operatively will be collected to include a repeat assessment of physical function with a 6-minute walk test, SF-36 assessment and HADS scores. Smoking cessation rate will be collected. A pre and post-intervention group will be studied over a 1-year period. We will report on the eligibility, acceptability and pre-operative effect of this trimodal rehabilitation programme. AIM AND EXPECTED IMPACT This is a non-randomised pre-post intervention pilot study to understand the acceptability and pre-operative effects of a combined physical, psychological and social prehabilitation package in patients undergoing aneurysm repair. This will enable the design (feasibility and power) of a large scale Randomised Controlled Trial. Our hypotheses include: The introduction of a prehabilitation programme will be acceptable to the majority of patients undergoing aneurysm surgery A physical pre-operative exercise programme will increase physical fitness before surgery A psychological intervention based on cognitive behaviour therapy techniques will reduce anxiety before surgery and prepare patients better for their post-operative recovery The introduction of psycho-social counselling for smoking cessation will encourage more patients to give up smoking pre-operatively PARTICIPANT ENTRY: PATIENTS PRE-REGISTRATION EVALUATIONS The research team will identify eligible patients for recruitment into the study via clinic lists, multidisciplinary meetings and referral letters before the patient attends their clinic appointment. Only adult patients undergoing aortic surgery will be selected. Patient information leaflets will be given to selected patients and patients will be given the opportunity to read them and ask questions before deciding whether or not to participate. INCLUSION CRITERIA Adult patients (>18 years old) undergoing aortic aneurysm repair. Ability to comprehend and retain instructions regarding self-training Physical fitness allowing participation in an exercise programme. EXCLUSION CRITERIA Minors (<18 years old) Adult patients who do not have capacity to consent. Emergency or urgent procedures who will not have a necessary 6 week lead in time until operation. WITHDRAWRAL CRITERIA The patient will be made aware that they may withdraw from the study at any time without providing a reason; their care and treatment will not be affected STUDY DESIGN The acceptability of this programme will be studied and the pre-operative impact on functional capacity will be assessed in a comparator (pre-intervention) and post-intervention group. Patients Patients from Imperial College Healthcare NHS Trust Vascular Unit undergoing aortic aneurysm repair will be recruited. Study Protocol Our current vascular pre-operative assessment service is an established nurse led service, run by a dedicated aortic clinical nurse specialist. The prehabilitation would run in conjunction with the current pre-operative screening measures currently in place - which include dobutamine stress echocardiography, renal assessment and pulmonary function tests. -Phase 1 - Comparator (pre-intervention) evaluation Patients undergoing present standard of care - i.e. standard work-up for aneurysm repair without nurse-led prehabilitation strategy, who meet inclusion and exclusion criteria will be given a patient information leaflet, informed they are in the pre-intervention group and consented for inclusion in the study as detailed above. At the baseline appointment, on the same day as work-up tests, information will be collected on standardised data collection sheets to include: Patient demographics and medical history Baseline Quality of Life assessment using SF-36 forms Hospital anxiety and depression scale (HADS). Exercise testing by a standardised 6-minute walk test Peak Expiratory Flow Rate (PEFR) Information immediately pre-operatively will be collected the day before operation (our standard admission is the day before) to include a repeat assessment of physical function with a 6-minute walk test, Peak Expiratory Flow Rate (PEFR), SF-36 assessment and HADS scores. Smoking cessation rate over the pre-operative period will be collected. The aneurysm repair will proceed as standard of care, and will be unchanged from standard practice. -Phase 2 - Intervention Proposed intervention - The introduction of a biopsychosocial intervention before surgery. The physical exercise programme will be prescribed exercise training twice per week which will be supported by our vascular nurse specialist, previously shown to have a small effect on length of stay in cardiac patients [12]. A trained specialist (a registered psychologist) will also deliver a brief psychological intervention based on cognitive behavioral therapy (CBT) techniques in two sessions to modify illness, surgical preparation and rehabilitation beliefs. This psychological intervention has been shown to be effective in encouraging claudicants to initiate and continue exercise training [13]. Lastly patients will be counselled and referred to smoking cessation services as appropriate. Phase 2 protocol - During an initial set-up phase comprehensive information booklets will be developed to instruct the patient on these three modes of prehabilitation. Patients who are eligible for the study will be approached in the same way as patients studied in the comparator group. At the baseline study visit, the same baseline information will be collected as for the comparator group i.e.: At the baseline appointment, on the same day as work-up tests, information will be collected on standardised data collection sheets to include: Patient demographics and medical history Baseline Quality of Life assessment using SF-36 forms Hospital anxiety and depression scale (HADS). Exercise testing by a standardised 6-minute walk test Peak Expiratory Flow Rate (PEFR) In addition patients will receive: Information booklets Physical exercise plan, run-through and explanations. Psychological therapy on this day or a mutually convenient day for patient and therapist. Counselling by the nurse specialist and referral for smoking cessation Patients will receive a telephone follow-up with the nurse specialist at week 2 and week 4 to evaluate progress and to encourage compliance with the programme. Between weeks 5-6 the patient will have a further session with the clinical psychologist, just prior to admission for treatment, to prepare them for their impending hospitalisation. Again, information immediately pre-operatively will be collected to include a repeat assessment of physical function with a 6-minute walk test, Peak Expiratory Flow Rate (PEFR), SF-36 assessment and HADS score. In addition, patients will be asked to fill out a questionnaire assessing compliance with and acceptability of the prehabilitation programme. Smoking cessation rate will be collected. Data Collection The following demographic data will be recorded on standardised data collection forms for each patient, collected from patient records and the patient interviews: Inclusion and exclusion criteria Medical history/risk factors ASA classification Planned operative procedure details Physical status using functional capacity, measured in metabolic equivalents (METs), with a Duke Activity Status Index (score of less than 4 indicates poor physical function). Functional capacity may be usually expressed in metabolic equivalents (METs), where one MET is defined as the oxygen consumption of a 70-kg man at rest. Greater than 7 METs of activity tolerance is considered excellent, whereas less than 4 METs is considered poor activity tolerance. The Duke Activity Status Index suggests questions that correlate with MET levels; for example, walking on level ground at about 4 miles per hour or carrying a bag of groceries up a flight of stairs expends approximately 4 METs of activity. This system is used by the Cleveland clinic for pre-operative cardiac evaluation. It allows a pre-operative assessment of physical function to assess predicted ability to cope at home after surgery. A brief, self-completed questionnaire (Appendix 1) can provide a standardized assessment of functional status that correlates well with an objective measure of maximal exercise capacity [14]. Post-operative data will be collected for patients in order to plan for a further study based on reducing length of stay. Inpatient complications: grade and details using standardised data collection sheets Length of stay HDU/ITU use Mortality At base line visit and prior to operation each patient will be assessed using: Baseline Quality of Life assessment using SF-36 forms Hospital anxiety and depression scale (HADS). Exercise testing by a standardised 6-minute walk test Peak Expiratory Flow Rate (PEFR) An event log will be recorded for each patient throughout the study period. Patients undergoing intervention will be asked to complete a short questionnaire on compliance and acceptability of the prehabilitation programme. ANALYSIS Completed data collection sheets will be analysed for omissions and missing data completed before being logged onto a central database and analysed by the research team at Imperial College, London, St. Mary's Campus. The two groups will be compared using simple statistical methods. We intend to analyse and report on the following The number of patients who accepted inclusion into a pre-operative prehabilitation programme will be calculated. 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 pre and post-intervention groups. The effects on quality of life. The effect of a programme on anxiety and depression on each study participant will be assessed. The number of patients who are able to reduce or cease smoking will be reported. Compliance and acceptability of the prehabilitation programme. Morbidity and Mortality, HDU/ITU resource use as well as Length of hospital stay after aortic surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aortic Aneurysm

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Masking Description
    Open label
    Allocation
    Non-Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pre-intervention
    Arm Type
    No Intervention
    Arm Description
    Patients treated as standard before intervention
    Arm Title
    Post-intervention arm = Prehabilitation
    Arm Type
    Active Comparator
    Arm Description
    Introduction of rehabilitation program
    Intervention Type
    Behavioral
    Intervention Name(s)
    Post-intervention arm = Prehabilitation
    Intervention Description
    Introduction of a physical exercise training programme, psychological counselling and smoking cessation advice
    Primary Outcome Measure Information:
    Title
    The Number of Patients Who Accepted Inclusion Into a Pre-operative Prehabilitation Programme
    Description
    This describes the number of people within the study who were in the pre-habilitation study arm that accepted and completed the pre-habilitation training
    Time Frame
    Collected at screening
    Title
    Change From Baseline in Metabolic Equivalents (METS) at Six Weeks
    Description
    • Metabolic equivalent level is a measure of physical fitness. One MET is defined as 3.5 mL 02 uptake/kg per minute which is the resting oxygen uptake in a sitting position. The achieved exercise capacity in METs has been shown to be predictive in older adult population of survival with higher MET levels associated with improved survival," or similar definition that is accurate and appropriate.
    Time Frame
    Collected at baseline and (expected) 6 weeks
    Title
    Decrease in Anxiety and Depression Scores (Hospital Anxiety and Depression Scale)
    Description
    HADS is a validated questionnaire consisting of 7 statements relating to anxiety and 7 statements relating to depression. Each statement is scored between 0 and 3 giving a total score of up to 21 for each section. A score of 0-7 is assumed to be normal and score greater than this suggestive of a mood disorder
    Time Frame
    Collected at baseline and (expected) 6 weeks
    Title
    Number of Participants With Attendance at the Physical and Psychological and Social Training Appointments of the Rehabilitation Programme (Assessed by Bespoke Questionnaire)
    Time Frame
    Collected at baseline and during the study
    Secondary Outcome Measure Information:
    Title
    HDU/ITU Resource Use (Number of Days Stay)
    Description
    Observation to power a larger intervention study
    Time Frame
    Collected at (expected) 6 weeks +hospital stay
    Title
    LOS
    Description
    Length of hospital stay after aortic surgery (number of days) - Observation to power a larger intervention study
    Time Frame
    Collected at (expected) 6 weeks +hospital stay

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    95 Years
    Accepts Healthy Volunteers
    No
    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)

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    This trial did not complete as expected and therefore there are no meaningful participant data to share.
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    Trimodal Prehabilitation for Aneurysm Surgery Study

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