Digital Prehabilitation for Patients Undergoing Major Elective Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery
• Intervention / Treatment: Behavioral: Six weeks of digital 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.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alec Snow, MBChB; Phone Number: 07793554479; Email: alec.snow@nhs.net

Study Locations

• United Kingdom
  • Somerset
    • Bath, Somerset, United Kingdom, BA1 3NG
      • Recruiting
      • Royal United Hospitals Bath NHS Foundation Trust
      • Contact: Alec Snow, MBChB; Phone Number: 07793554479; Email: alec.snow@nhs.net
      • Principal Investigator: Alec Snow, MBChB
    • Bath, Somerset, United Kingdom, BA2 7AY
      • Active, not recruiting
      • University of Bath

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Six weeks of digital prehabilitation; The digital prehabilitation programme comprises three 35-minute exercise sessions per week, including a warm-up, vigorous intensity aerobic and resistance exercises, and breathing exercises. The digital prehabilitation programme will be tailored to the participant's mobility level and fitness level, which will be assessed via in-platform questionnaires and functional assessments. Functional assessments will be repeated every two weeks to adapt the prehabilitation programme according to changes in fitness level. Within PreActiv's website, participants will be enrolled into a managed community forum of patients and healthcare professionals where they can post their achievements and questions. Alongside access to PreActiv's digital prehabilitation, patients will be given educational materials that summarise the benefits of prehabilitation and how to realise them.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	The proportion of patients invited that provide written informed consent	6 weeks
Uptake	The proportion of patients invited that are willing to be screened for eligibility	6 weeks
Screen-pass rate	The proportion of willing patients that pass screening for eligibility	6 weeks
Adherence	The proportion of exercise sessions offered that are attended	6 weeks
Compliance	The proportion of exercise sessions that are completed as prescribed	6 weeks
Retention	The proportion of patients that enrol into the study who complete follow-up measurements	6 weeks
Safety (adverse events)	The incidence and severity of adverse events	6 weeks
Acceptability	Likert scale and open-ended feedback survey questions, posts in community forum	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiorespiratory fitness	Assessed via cardiopulmonary exercise tests on a cycle ergometer, with measurements derived including VO2peak (ml/kg/min) and ventilatory threshold (ml/kg/min)	Change from pre-intervention (week 0) to post-intervention (week 7)
Resting blood pressure	Assessed via three measurements using an automated sphygmomanometer (mmHg)	Change from pre-intervention (week 0) to post-intervention (week 7)
Resting heart rate	Assessed via three measurements using an automated sphygmomanometer (bpm)	Change from pre-intervention (week 0) to post-intervention (week 7)
Physical activity level	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.	Change from pre-intervention (week 0) to post-intervention (week 7)
Mood	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.	Change from pre-intervention (week 0) to post-intervention (week 7)
Quality of life	Assessed via EuroQol EQ-5D-5L questionnaire. The highest possible score for each of the five sub-scales is 5 and the lowest possible score for each sub-scale is 1. For sub-scales, a lower score is favourable as it indicates a higher quality of life. A visual analogue scale is also included, with a highest possible score of 100 and a lowest possible score of 0. For the visual analogue scale, a higher score is favourable as it indicates better quality of life.	Change from pre-intervention (week 0) to post-intervention (week 7)
Functional fitness	Assessed via the number of repetitions completed during a 1-minute sit-to-stand test (for participants that are able to transfer independently) or 1-minute seated push-up test (for participants who are unable, or require support, to transition from seated to standing)	Change from pre-intervention (week 0) to post-intervention (week 7), plus in-platform assessments in week 1, week 2, week 4, and week 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Economic impact	Cost per patient to deliver PreActiv's digital prehabilitation, with comparison to published costs for face-to-face and telemedicine prehabilitation programmes	6 weeks
Carbon emissions avoided with home-based vs. face-to-face prehabilitation	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.	6 weeks

Collaborators and Investigators

• Sponsor: Royal United Hospitals Bath NHS Foundation Trust
• Collaborators: University of Bath; PreActiv
• Investigators: Principal Investigator: Alec Snow, MBChB, Royal United Hospitals Bath NHS Foundation Trust

Publications and helpful links

General Publications

• Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available.
• Fletcher GF, Ades PA, Kligfield P, Arena R, Balady GJ, Bittner VA, Coke LA, Fleg JL, Forman DE, Gerber TC, Gulati M, Madan K, Rhodes J, Thompson PD, Williams MA; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology, Council on Nutrition, Physical Activity and Metabolism, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention. Exercise standards for testing and training: a scientific statement from the American Heart Association. Circulation. 2013 Aug 20;128(8):873-934. doi: 10.1161/CIR.0b013e31829b5b44. Epub 2013 Jul 22. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Prehabilitation; Digital health; Major surgery
• Other Study ID Numbers: 333460

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No