Digital Prehabilitation for Patients Undergoing Major Elective Surgery

NCT06137781 | Completed Results

• 1 other identifier: 333460
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Surgery

Keywords

Prehabilitation; Exercise; Major surgery; Digital health

Outcome Measures

Primary Outcomes (6)

• Number of Participants Recruited

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

  4 months

• Number of Participants Interested in Participating

  The number of patients invited that are willing to be screened for eligibility, with percentage calculated

  4 months

• Number of Participants That Passed Screening

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

  4 months

• Number of Adherent Participants

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

  6 weeks

• Percentage of Compliant Exercise Sessions

  The percentage of exercise sessions that are completed as prescribed in terms of intensity, duration, and type of exercise

  6 weeks

• Number of Participants Retained

  The number of patients that enrol into the study who complete follow-up measurements, with percentage calculated

  6 weeks

Secondary Outcomes (7)

• Cardiorespiratory Fitness

  Change from pre-intervention (week 0) to post-intervention (week 7)

• Resting Blood Pressure

  Change from pre-intervention (week 0) to post-intervention (week 7)

• Resting Heart Rate

  Change from pre-intervention (week 0) to post-intervention (week 7)

• Physical Activity Level

  Change from pre-intervention (week 0) to post-intervention (week 7)

• Anxiety and Depression

  Change from pre-intervention (week 0) to post-intervention (week 7)

Other Outcomes (1)

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

  6 weeks

Study Arms (1)

Six weeks of digital prehabilitation

EXPERIMENTAL

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

Interventions

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.

Six weeks of digital prehabilitation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal United Hospitals Bath NHS Foundation Trust: lead
• University of Bath: collaborator
• PreActiv: collaborator

Study Sites (2)

Royal United Hospitals Bath NHS Foundation Trust

Bath, Somerset, BA1 3NG, United Kingdom

Location

University of Bath

Bath, Somerset, BA2 7AY, United Kingdom

Location

Related 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.

  PMID: 23877260 BACKGROUND

• 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.

  PMID: 23851406 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

The lack of control group and small sample size precludes our ability to definitively attribute any effects on fitness, health, and wellbeing to the intervention.

Results Point of Contact

• Title: Alec Snow
• Organization: Royal United Hospitals Bath NHS Foundation Trust

alec.snow@nhs.net

07793554479

Study Officials

• Alec Snow, MBChB

  Royal United Hospitals Bath NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 18, 2023
• Study Start: February 19, 2024
• Primary Completion: September 17, 2024
• Study Completion: September 17, 2024
• Last Updated: December 17, 2025
• Results First Posted: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)