Digital Prehabilitation for Patients Undergoing Major Elective Surgery

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06137781
• Other study ID #: 333460
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2024
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: Royal United Hospitals Bath NHS Foundation Trust
• Contact: Alec Snow, MBChB
• Phone: 07793554479
• Email: alec.snow[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Royal United Hospitals Bath NHS Foundation Trust	Bath	Somerset
United Kingdom	University of Bath	Bath	Somerset

Sponsors (3)

Lead Sponsor	Collaborator
Royal United Hospitals Bath NHS Foundation Trust	PreActiv, University of Bath

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Recruitment rate	The proportion of patients invited that provide written informed consent	6 weeks
Primary	Uptake	The proportion of patients invited that are willing to be screened for eligibility	6 weeks
Primary	Screen-pass rate	The proportion of willing patients that pass screening for eligibility	6 weeks
Primary	Adherence	The proportion of exercise sessions offered that are attended	6 weeks
Primary	Compliance	The proportion of exercise sessions that are completed as prescribed	6 weeks
Primary	Retention	The proportion of patients that enrol into the study who complete follow-up measurements	6 weeks
Primary	Safety (adverse events)	The incidence and severity of adverse events	6 weeks
Primary	Acceptability	Likert scale and open-ended feedback survey questions, posts in community forum	6 weeks
Secondary	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)
Secondary	Resting blood pressure	Assessed via three measurements using an automated sphygmomanometer (mmHg)	Change from pre-intervention (week 0) to post-intervention (week 7)
Secondary	Resting heart rate	Assessed via three measurements using an automated sphygmomanometer (bpm)	Change from pre-intervention (week 0) to post-intervention (week 7)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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