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Completed

NCT Number: NCT06137781

Digital Prehabilitation for Patients Undergoing Major Elective Surgery

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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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal United Hospitals Bath NHS Foundation Trust, Bath, Somerset, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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
  • Any condition and/or behaviour that would pose undue personal risk or introduce bias into the study
  • Currently enrolled in another research trial

Treatment and study plan

Six weeks of digital prehabilitation

Behavioral

All participants will be allocated to receive six weeks of digital prehabilitation via PreActiv's website, plus usual care.

Primary outcomes

  1. Number of Participants Recruited

    Time frame: 4 months

    The number of patients invited that provide written informed consent, with percentage calculated

  2. 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

  3. Number of Participants That Passed Screening

    Time frame: 4 months

    The number of willing patients that pass screening for eligibility, with percentage calculated

  4. Number of Adherent Participants

    Time frame: 6 weeks

    The number of participants who complete all exercise sessions, with percentage calculated

  5. 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

  6. 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

  1. Cardiorespiratory Fitness

    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.

  2. Resting Blood Pressure

    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)

  3. Resting Heart Rate

    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)

  4. Physical Activity Level

    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.

  5. Anxiety and Depression

    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.

  6. Quality of Life EQ-5D Visual Analogue Scale

    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.

  7. 1-minute Sit-to-stand Test

    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.

Other outcomes

  1. Carbon Emissions Avoided With Home-based vs. Face-to-face Prehabilitation

    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.

Sponsors and collaborators

Lead sponsor

Royal United Hospitals Bath NHS Foundation Trust

Other

Collaborators

  • PreActiv
  • University of Bath

Registry information

Official study title

Digital Prehabilitation for Patients Undergoing Major Elective Surgery: a Single-arm Pilot Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
Dec 17, 2025

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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