Digital Prehabilitation for Patients Undergoing Major Elective Surgery

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06137781

Enrollment

Registered

2023-11-18

Start date

2024-02-19

Completion date

2024-09-17

Last updated

2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Keywords

Prehabilitation, Exercise, Major surgery, Digital health

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.

Interventions

BEHAVIORALSix weeks of digital prehabilitation

All participants will be allocated to receive six weeks of digital prehabilitation via PreActiv's website, plus usual care.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Retained	6 weeks	The number of patients that enrol into the study who complete follow-up measurements, with percentage calculated
Number of Participants Recruited	4 months	The number of patients invited that provide written informed consent, with percentage calculated
Number of Participants Interested in Participating	4 months	The number of patients invited that are willing to be screened for eligibility, with percentage calculated
Number of Participants That Passed Screening	4 months	The number of willing patients that pass screening for eligibility, with percentage calculated
Number of Adherent Participants	6 weeks	The number of participants who complete all exercise sessions, with percentage calculated
Percentage of Compliant Exercise Sessions	6 weeks	The percentage of exercise sessions that are completed as prescribed in terms of intensity, duration, and type of exercise

Secondary

Measure	Time frame	Description
Quality of Life EQ-5D Visual Analogue Scale	Change from pre-intervention (week 0) to post-intervention (week 7)	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.
1-minute Sit-to-stand Test	Change from pre-intervention (week 0) to post-intervention (week 7).	Assessed via the number of repetitions completed during a 1-minute sit-to-stand test.
Cardiorespiratory Fitness	Change from pre-intervention (week 0) to post-intervention (week 7)	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.
Resting Blood Pressure	Change from pre-intervention (week 0) to post-intervention (week 7)	Three measurements were made after 15 minutes seated rest using an automated sphygmomanometer, with the average (mean) of the three measurements reported (mmHg)
Resting Heart Rate	Change from pre-intervention (week 0) to post-intervention (week 7)	Three measurements were made after 15 minutes seated rest using an automated sphygmomanometer, with the average (mean) of the three measurements reported (bpm)
Physical Activity Level	Change from pre-intervention (week 0) to post-intervention (week 7)	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.
Anxiety and Depression	Change from pre-intervention (week 0) to post-intervention (week 7)	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.

Other

Measure	Time frame	Description
Carbon Emissions Avoided With Home-based vs. Face-to-face Prehabilitation	6 weeks	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.

Countries

United Kingdom

Participant flow

Recruitment details

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.

Participants by arm

Arm	Count
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.	24
Total	24

Arm

Count

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.

Total

Withdrawals & dropouts

Period	Reason	FG000
Baseline measurements	Expedited surgery	1
Baseline measurements	Lost to Follow-up	2
Baseline measurements	Withdrawal by Subject	1
Intervention period	Adverse Event	1
Intervention period	Expedited surgery	1
Intervention period	Lost to Follow-up	2
Intervention period	Withdrawal by Subject	3

Baseline characteristics

Characteristic	Six Weeks of Digital Prehabilitation
Age, Continuous	69 Years
Body mass index	29.1 kg/m2
Race/Ethnicity, Customized White British	24 Participants
Sex: Female, Male Female	14 Participants
Sex: Female, Male Male	10 Participants
Surgery type Cholecystectomy	1 Participants
Surgery type Hernia repair	3 Participants
Surgery type Hip replacement	3 Participants
Surgery type Hip revision	1 Participants
Surgery type Hysterectomy	2 Participants
Surgery type Knee replacement	3 Participants
Surgery type Knee revision	1 Participants
Surgery type Ovarian cystectomy	1 Participants
Surgery type Parathyroidectomy	3 Participants
Surgery type Prostatectomy	1 Participants
Surgery type Thyroidectomy	2 Participants
Surgery type Ureteral reimplantation	1 Participants
Surgery type Vaginal prolapse repair	2 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 35
other Total, other adverse events	6 / 35
serious Total, serious adverse events	2 / 35

Outcome results

Primary

Number of Adherent Participants

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

Time frame: 6 weeks

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Six weeks of digital prehabilitation	Number of Adherent Participants	21 Participants

Primary

Number of Participants Interested in Participating

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

Time frame: 4 months

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Six weeks of digital prehabilitation	Number of Participants Interested in Participating	39 Participants

Primary

Number of Participants Recruited

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

Time frame: 4 months

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Six weeks of digital prehabilitation	Number of Participants Recruited	35 Participants

Primary

Number of Participants Retained

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

Time frame: 6 weeks

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Six weeks of digital prehabilitation	Number of Participants Retained	24 Participants

Primary

Number of Participants That Passed Screening

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

Time frame: 4 months

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Six weeks of digital prehabilitation	Number of Participants That Passed Screening	35 Participants

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

Time frame: 6 weeks

Arm	Measure	Value (MEAN)
Six weeks of digital prehabilitation	Percentage of Compliant Exercise Sessions	79 Percentage

Secondary

1-minute Sit-to-stand Test

Assessed via the number of repetitions completed during a 1-minute sit-to-stand test.

Time frame: Change from pre-intervention (week 0) to post-intervention (week 7).

Population: 19/24 participants completed 1-minute sit-to-stand testing.

Arm	Measure	Value (MEDIAN)
Six weeks of digital prehabilitation	1-minute Sit-to-stand Test	11 Repetitions

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.