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| Name | Class |
|---|---|
| University of Bath | OTHER |
| PreActiv | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from pre-intervention (week 0) to post-intervention (week 7) |
| Resting Blood Pressure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alec Snow, MBChB | Royal United Hospitals Bath NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal United Hospitals Bath NHS Foundation Trust | Bath | Somerset | BA1 3NG | United Kingdom | ||
| University of Bath |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23877260 | Background | 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. | |
| 23851406 |
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Recruitment was completed between 19th February 2024 and 19th June 2024. Recruitment took place within the preoperative assessment clinic at the Royal United Hospitals Bath NHS Foundation Trust.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline measurements |
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| Intervention period |
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| Follow-up measurements |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Recruited | The number of patients invited that provide written informed consent, with percentage calculated | Posted | Count of Participants | Participants | 4 months |
|
From enrollment to end of follow-up, an average of 8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction (onset at work) | Cardiac disorders | Non-systematic Assessment | Assessed by the research team as not related to the intervention and reported to Sponsor. Pre-existing cardiac history. Onset of symptoms whilst at work. Successful treatment, but withdrawn from study as no longer eligible. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infectious illness (e.g., cold/flu) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Exercise session delayed due to infectious illness (e.g., cold/flu). |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alec Snow | Royal United Hospitals Bath NHS Foundation Trust | 07793554479 | alec.snow@nhs.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2024 | Nov 30, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Three measurements were made after 15 minutes seated rest using an automated sphygmomanometer, with the average (mean) of the three measurements reported (mmHg) |
| 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) | 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) |
| 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. | 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. | 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. | Change from pre-intervention (week 0) to post-intervention (week 7). |
| 6 weeks |
| Bath |
| Somerset |
| BA2 7AY |
| United Kingdom |
| 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. |
| 41776650 | Derived | Emery 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. |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Surgery type | Count of Participants | Participants |
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| Body mass index | Median | Inter-Quartile Range | kg/m2 |
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| Primary | Number of Participants Interested in Participating | The number of patients invited that are willing to be screened for eligibility, with percentage calculated | Posted | Count of Participants | Participants | 4 months |
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| Primary | Number of Participants That Passed Screening | The number of willing patients that pass screening for eligibility, with percentage calculated | Posted | Count of Participants | Participants | 4 months |
|
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| Primary | Number of Adherent Participants | The number of participants who complete all exercise sessions, with percentage calculated | Posted | Count of Participants | Participants | 6 weeks |
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| Secondary | 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. | 21/24 participants completed cardiopulmonary exercise testing. | Posted | Median | Inter-Quartile Range | ml/kg/min | Change from pre-intervention (week 0) to post-intervention (week 7) |
|
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| Secondary | 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) | Posted | Median | Inter-Quartile Range | mmHg | Change from pre-intervention (week 0) to post-intervention (week 7) |
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| Secondary | 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) | Posted | Median | Inter-Quartile Range | beats/minute | Change from pre-intervention (week 0) to post-intervention (week 7) |
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| 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. | 20/24 participants provided complete IPAQ-short form responses for calculation of total physical activity. | Posted | Median | Inter-Quartile Range | MET-minutes/week | Change from pre-intervention (week 0) to post-intervention (week 7) |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | Points | Change from pre-intervention (week 0) to post-intervention (week 7) |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | Percentage | Change from pre-intervention (week 0) to post-intervention (week 7) |
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| Secondary | 1-minute Sit-to-stand Test | Assessed via the number of repetitions completed during a 1-minute sit-to-stand test. | 19/24 participants completed 1-minute sit-to-stand testing. | Posted | Median | Inter-Quartile Range | Repetitions | Change from pre-intervention (week 0) to post-intervention (week 7). |
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| Other Pre-specified | 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. | Posted | Median | Inter-Quartile Range | Kilograms of carbon emissions avoided | 6 weeks |
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| Primary | Percentage of Compliant Exercise Sessions | The percentage of exercise sessions that are completed as prescribed in terms of intensity, duration, and type of exercise | Posted | Mean | 95% Confidence Interval | Percentage | 6 weeks |
|
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| Primary | Number of Participants Retained | The number of patients that enrol into the study who complete follow-up measurements, with percentage calculated | Posted | Count of Participants | Participants | 6 weeks |
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| 0 |
| 35 |
| 2 |
| 35 |
| 6 |
| 35 |
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| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment | Assessed by the research team as not related to the intervention and reported to Sponsor. Diverticulitis was pre-existing. Treatment in hospital only required due to presenting out-of-hours. Patient discharged the next day and completed study. |
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| Injury sustained at work | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Exercise session delayed due to injuries sustained at work. |
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| Flare-up of fibromyalgia | Nervous system disorders | Non-systematic Assessment | Exercise session delayed due to flare-up of fibromyalgia symptoms. |
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| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment | Exercise session delayed due to diverticulitis symptoms. |
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