Clinical trial NCT06137781: Digital Prehabilitation for Patients Undergoing Major Elective Surgery
Official title: Digital Prehabilitation for Patients Undergoing Major Elective Surgery: a Single-arm Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: Prehabilitation
Exercise
Major surgery
Digital health
Lead sponsor: Royal United Hospitals Bath NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Bath
name: PreActiv
First posted: 2023-11-18
Enrollment: 35
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Recruitment rate
timeFrame: 6 weeks
measure: Uptake
timeFrame: 6 weeks
measure: Screen-pass rate
timeFrame: 6 weeks
measure: Adherence
timeFrame: 6 weeks
measure: Compliance
timeFrame: 6 weeks
measure: Retention
timeFrame: 6 weeks
measure: Safety (adverse events)
timeFrame: 6 weeks
measure: Acceptability
timeFrame: 6 weeks
Secondary outcomes:
measure: Cardiorespiratory fitness
timeFrame: Change from pre-intervention (week 0) to post-intervention (week 7)
measure: Resting blood pressure
timeFrame: Change from pre-intervention (week 0) to post-intervention (week 7)
measure: Resting heart rate
timeFrame: Change from pre-intervention (week 0) to post-intervention (week 7)
measure: Physical activity level
timeFrame: Change from pre-intervention (week 0) to post-intervention (week 7)
measure: Mood
timeFrame: Change from pre-intervention (week 0) to post-intervention (week 7)
measure: Quality of life
timeFrame: Change from pre-intervention (week 0) to post-intervention (week 7)
measure: Functional fitness
timeFrame: 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 outcomes:
measure: Economic impact
timeFrame: 6 weeks
measure: Carbon emissions avoided with home-based vs. face-to-face prehabilitation
timeFrame: 6 weeks
Locations:
city: Bath
country: United Kingdom
facility: Royal United Hospitals Bath NHS Foundation Trust
state: Somerset
city: Bath
country: United Kingdom
facility: University of Bath
state: Somerset
Study officials:
affiliation: Royal United Hospitals Bath NHS Foundation Trust
name: Alec Snow, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.