Six weeks of digital prehabilitation
BehavioralAll participants will be allocated to receive six weeks of digital prehabilitation via PreActiv's website, plus usual care.
NCT Number: NCT06137781
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.
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Notify Me50 year and older
All sexes
Interventional
Not applicable
Royal United Hospitals Bath NHS Foundation Trust, Bath, Somerset, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All participants will be allocated to receive six weeks of digital prehabilitation via PreActiv's website, plus usual care.
Time frame: 4 months
The number of patients invited that provide written informed consent, with percentage calculated
Time frame: 4 months
The number of patients invited that are willing to be screened for eligibility, with percentage calculated
Time frame: 4 months
The number of willing patients that pass screening for eligibility, with percentage calculated
Time frame: 6 weeks
The number of participants who complete all exercise sessions, with percentage calculated
Time frame: 6 weeks
The percentage of exercise sessions that are completed as prescribed in terms of intensity, duration, and type of exercise
Time frame: 6 weeks
The number of patients that enrol into the study who complete follow-up measurements, with percentage calculated
Time frame: Change from pre-intervention (week 0) to post-intervention (week 7)
Assessed via a maximal cardiopulmonary exercise test performed on a cycle ergometer, with measurements of VO2peak (ml/kg/min) and ventilatory threshold (ml/kg/min) derived.
Time frame: Change from pre-intervention (week 0) to post-intervention (week 7)
Three measurements were made after 15 minutes seated rest using an automated sphygmomanometer, with the average (mean) of the three measurements reported (mmHg)
Time frame: Change from pre-intervention (week 0) to post-intervention (week 7)
Three measurements were made after 15 minutes seated rest using an automated sphygmomanometer, with the average (mean) of the three measurements reported (bpm)
Time frame: Change from pre-intervention (week 0) to post-intervention (week 7)
Assessed via International Physical Activity Questionnaire (IPAQ) short-form. After data processing, the highest possible score is 25,704 MET-minutes/week and the lowest possible score is 0 MET-minutes/week. A higher score is favourable as it indicates a higher physical activity level.
Time frame: Change from pre-intervention (week 0) to post-intervention (week 7)
Assessed via Hospital Anxiety and Depression Scale (HADS). The highest possible score is 21 and the lowest possible score is 0 for both the anxiety and depression sub-scores. A lower score is favourable as it indicates lower anxiety/depression.
Time frame: Change from pre-intervention (week 0) to post-intervention (week 7)
Assessed via EuroQol EQ-5D visual analogue scale, with a highest possible score of 100 and a lowest possible score of 0. A higher score is favourable as it indicates better quality of life.
Time frame: Change from pre-intervention (week 0) to post-intervention (week 7).
Assessed via the number of repetitions completed during a 1-minute sit-to-stand test.
Time frame: 6 weeks
An estimation of the carbon emissions avoided by performing prehabilitation at home via PreActiv's digital prehabilitation compared to the estimated hypothetical emissions associated with participants travelling to the hospital three times per week for six weeks for face-to-face prehabilitation. Publicly-available carbon emissions data will be used for calculations.
Royal United Hospitals Bath NHS Foundation Trust
Other
Digital Prehabilitation for Patients Undergoing Major Elective Surgery: a Single-arm Pilot Study
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