Digital Prehabilitation for Patients Undergoing Major Elective Surgery: a Single-arm Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Surgery
- Sponsor
- Royal United Hospitals Bath NHS Foundation Trust
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Number of Participants Recruited
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
Prehabilitation describes the process of improving someone's functional capacity before major surgery. Prehabilitation commonly focuses on exercise training, as fitness level is a predictor of surgical outcomes - the fitter you are before surgery, the lower the risk of complications after surgery. Typically, exercise training is done at the hospital, but research shows that patients would prefer to do prehabilitation exercises in their home.
The goal of this study is to test the feasibility of an online prehabilitation programme made by PreActiv, which can be accessed at home via a website by patients who are awaiting major surgery. PreActiv's prehabilitation programme is six weeks long, and involves three 35-minute exercise sessions per week, with each session including a warm-up, cardio exercises, muscle strengthening exercises, and breathing exercises. Information from this pilot study on the number of exercise sessions attended (adherence) and the number of patients who complete the study (retention) will be used to decide whether we should progress to a larger study that assesses the effectiveness of PreActiv's prehabilitation.
Detailed Description
This is a single-arm pilot study to assess the feasibility of PreActiv's digital prehabilitation alongside usual care at the Royal United Hospitals Bath NHS Foundation Trust. The novel provision of tailored, progressive, dynamic, evidence-based, and home-based prehabilitation via PreActiv's digital platform requires evaluation for feasibility, prior to a larger, randomised-controlled trial assessing efficacy. Such research is warranted, as patients indicate a preference to complete prehabilitation at home, rather than at the hospital, but current home-based prehabilitation programmes are one-size-fits-all, and do not adapt to changes in fitness level. Patients awaiting major surgery and aged 50 years or older will be identified by preoperative nurses and screened by a member of the research team at the Royal United Hospitals Bath NHS Foundation Trust. Eligible patients who provide written informed consent will then be invited to attend a measurement visit at the University of Bath for baseline assessments of fitness, blood pressure, physical activity level, and wellbeing in week 0. All participants will then enrol onto PreActiv's website, and a six-week, thrice weekly prehabilitation programme will be created for them based on their mobility and fitness level. Measurements at the University of Bath will be repeated in week 7 to assess the preliminary efficacy of PreActiv's digital prehabilitation. Feasibility outcomes will be used to inform the design of a potential future randomised-controlled trial measuring change to cardiorespiratory fitness as the primary outcome. The decision to progress to a randomised-controlled trial will be based on pre-defined progression criteria for adherence and retention in this pilot study. In addition, participant feedback will be used to refine the study design and intervention.
Investigators
Alec Snow
Chief Investigator
Royal United Hospitals Bath NHS Foundation Trust
Eligibility Criteria
Inclusion Criteria
- •Planned for major elective surgery ≥10 weeks from time of recruitment Major or complex surgery examples in NICE guideline NG45 'Routine preoperative tests for elective surgery' provides appropriate examples that are relevant to the patient cohort at the Royal United Hospitals Bath NHS Foundation Trust (RUH). We have extrapolated from these examples a list of surgical procedures that qualify as major or complex surgery and are carried out at the RUH. This list is not exhaustive but provides a range of procedures that are applicable for example: laparotomy, joint replacement, total abdominal hysterectomy, nephrectomy, neck dissection, parotidectomy, endoscopic resection of prostate, thyroidectomy.
- •Aged ≥50 years
Exclusion Criteria
- •Surgery scheduled in \<10 weeks
- •Any relative or absolute contraindications to undertake an exercise test as described by the American College of Sports Medicine (ACSM, 2022) and the American Heart Association (Fletcher et al., 2013)
- •Unsuitable to increase physical activity level as determined by Physical Activity Readiness Questionnaire (PAR-Q)
- •Uncontrolled or poorly-controlled lung condition, diabetes, or seizures
- •Recent (\<12 months) cardiovascular events needing hospital admission
- •Ongoing infection or wound making this programme hazardous for the patient
- •Unable to access technology required to use the PreActiv digital platform
- •Currently meeting World Health Organisation (WHO) physical activity guidelines of 75- 300 minutes of moderate to vigorous intensity physical activity per week, plus twice-weekly muscle strengthening activities
- •Unable to understand explanations and/or provide informed consent
- •Unable to understand written or spoken English, and without ongoing access to an interpreter
Outcomes
Primary Outcomes
Number of Participants Recruited
Time Frame: 4 months
The number of patients invited that provide written informed consent, with percentage calculated
Number of Participants Interested in Participating
Time Frame: 4 months
The number of patients invited that are willing to be screened for eligibility, with percentage calculated
Number of Participants That Passed Screening
Time Frame: 4 months
The number of willing patients that pass screening for eligibility, with percentage calculated
Number of Adherent Participants
Time Frame: 6 weeks
The number of participants who complete all exercise sessions, with percentage calculated
Percentage of Compliant Exercise Sessions
Time Frame: 6 weeks
The percentage of exercise sessions that are completed as prescribed in terms of intensity, duration, and type of exercise
Number of Participants Retained
Time Frame: 6 weeks
The number of patients that enrol into the study who complete follow-up measurements, with percentage calculated
Secondary Outcomes
- Cardiorespiratory Fitness(Change from pre-intervention (week 0) to post-intervention (week 7))
- Resting Blood Pressure(Change from pre-intervention (week 0) to post-intervention (week 7))
- Resting Heart Rate(Change from pre-intervention (week 0) to post-intervention (week 7))
- Physical Activity Level(Change from pre-intervention (week 0) to post-intervention (week 7))
- Anxiety and Depression(Change from pre-intervention (week 0) to post-intervention (week 7))
- Quality of Life EQ-5D Visual Analogue Scale(Change from pre-intervention (week 0) to post-intervention (week 7))
- 1-minute Sit-to-stand Test(Change from pre-intervention (week 0) to post-intervention (week 7).)