SurgeryNCT06137781
Digital Prehabilitation for Patients Undergoing Major Elective Surgery
A study testing Six weeks of digital prehabilitation in people with Surgery, run by Royal United Hospitals Bath NHS Foundation Trust at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Six weeks of digital prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 19 Feb 2024to 17 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal United Hospitals Bath NHS Foundation Trust
Bath, Somerset, BA1 3NG
University of Bath
Bath, Somerset, BA2 7AY
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgery
- Being tested
- Six weeks of digital prehabilitation
- Keywords
- Prehabilitation, Exercise, Major surgery, Digital health
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six weeks of digital prehabilitationBehavioural
All participants will be allocated to receive six weeks of digital prehabilitation via PreActiv's website, plus usual care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Six weeks of digital prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Recruited
The number of patients invited that provide written informed consent, with percentage calculated
Measured: 4 months
Number of Participants Interested in Participating
The number of patients invited that are willing to be screened for eligibility, with percentage calculated
Measured: 4 months
Number of Participants That Passed Screening
The number of willing patients that pass screening for eligibility, with percentage calculated
Measured: 4 months
Number of Adherent Participants
The number of participants who complete all exercise sessions, with percentage calculated
Measured: 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
Measured: 6 weeks
Number of Participants Retained
The number of patients that enrol into the study who complete follow-up measurements, with percentage calculated
Measured: 6 weeks
Secondary outcomes (7)
Cardiorespiratory Fitness
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.
Measured: Change from pre-intervention (week 0) to post-intervention (week 7)
Resting Blood Pressure
Three measurements were made after 15 minutes seated rest using an automated sphygmomanometer, with the average (mean) of the three measurements reported (mmHg)
Measured: Change from pre-intervention (week 0) to post-intervention (week 7)
Resting Heart Rate
Three measurements were made after 15 minutes seated rest using an automated sphygmomanometer, with the average (mean) of the three measurements reported (bpm)
Measured: 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.
Measured: Change from pre-intervention (week 0) to post-intervention (week 7)
Anxiety and Depression
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.
Measured: Change from pre-intervention (week 0) to post-intervention (week 7)
Quality of Life EQ-5D Visual Analogue Scale
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.
Measured: Change from pre-intervention (week 0) to post-intervention (week 7)
1-minute Sit-to-stand Test
Assessed via the number of repetitions completed during a 1-minute sit-to-stand test.
Measured: Change from pre-intervention (week 0) to post-intervention (week 7).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start19 Feb 2024
- Primary completion17 Sep 2024
- Study completion17 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal United Hospitals Bath NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bath, PreActiv
- Responsible party
- Principal investigator, Alec Snow, Royal United Hospitals Bath NHS Foundation Trust
- Investigators
- Alec Snow, MBChB, Principal investigator, Royal United Hospitals Bath NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137781
- Sponsor's protocol ID
- 333460
- Status last verified
- Dec 2025
- First submitted
- 8 Nov 2023
- Last updated
- 17 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23877260Thompson 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.
PubMed 23851406Emery A, Allam R, Quinn D, Sims H, Liang IJ, Spellanzon B, Groot J, Aspbury A, Bullough H, Ingham L, Archman J, Brown F, Perkin OJ, Snow A, Western MJ. The feasibility of implementing and evaluating individualised digital prehabilitation prior to major elective surgery in adults aged >/= 50 years: the PreActiv intervention. Perioper Med (Lond). 2026 Mar 3;15(1):39. doi: 10.1186/s13741-026-00663-8.
PubMed 41776650
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Prehabilitation for Patients Undergoing Major Elective Surgery: a Single-arm Pilot Study
- ClinicalTrials.gov ID
- NCT06137781
- Acronym / sponsor ID
- 333460
- Conditions
- Surgery
- Keywords
- Prehabilitation, Exercise, Major surgery, Digital health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Royal United Hospitals Bath NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Bath, PreActiv
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 17 Sep 2024 (actual)
- Study completion
- 17 Sep 2024 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Posted 17 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Six weeks of digital prehabilitation | Experimental | Behavioral: Six weeks of digital prehabilitationThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Six weeks of digital prehabilitationAll participants will be allocated to receive six weeks of digital prehabilitation via PreActiv's website, plus usual care. | Behavioural | Six weeks of digital prehabilitation |
Primary outcome
Number of Participants Recruited
Time frame: 4 months
The number of patients invited that provide written informed consent, with percentage calculated
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
Number of Participants That Passed Screening
Time frame: 4 months
The number of willing patients that pass screening for eligibility, with percentage calculated
Number of Adherent Participants
Time frame: 6 weeks
The number of participants who complete all exercise sessions, with percentage calculated
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
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
7 secondary outcomes
Cardiorespiratory Fitness
Time frame: Change from pre-intervention (week 0) to post-intervention (week 7)
Resting Blood Pressure
Time frame: Change from pre-intervention (week 0) to post-intervention (week 7)
Resting Heart Rate
Time frame: Change from pre-intervention (week 0) to post-intervention (week 7)
Physical Activity Level
Time frame: Change from pre-intervention (week 0) to post-intervention (week 7)
Anxiety and Depression
Time frame: Change from pre-intervention (week 0) to post-intervention (week 7)
Quality of Life EQ-5D Visual Analogue Scale
Time frame: Change from pre-intervention (week 0) to post-intervention (week 7)
1-minute Sit-to-stand Test
Time frame: Change from pre-intervention (week 0) to post-intervention (week 7).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23877260Fletcher 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.
- Background: PubMed 23851406Thompson 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.
- Derived from this study: PubMed 41776650Emery A, Allam R, Quinn D, Sims H, Liang IJ, Spellanzon B, Groot J, Aspbury A, Bullough H, Ingham L, Archman J, Brown F, Perkin OJ, Snow A, Western MJ. The feasibility of implementing and evaluating individualised digital prehabilitation prior to major elective surgery in adults aged >/= 50 years: the PreActiv intervention. Perioper Med (Lond). 2026 Mar 3;15(1):39. doi: 10.1186/s13741-026-00663-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alec Snow, MBChB principal investigator
Royal United Hospitals Bath NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Six weeks of digital prehabilitation in people with Surgery, run by Royal United Hospitals Bath NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Recruited (time frame: 4 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06137781, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.