Digital prehabilitation for patients undergoing major elective surgery
Research type
Research Study
Full title
Digital prehabilitation for patients undergoing major elective surgery: a single-arm pilot study
IRAS ID
333460
Contact name
Alec Snow
Contact email
Sponsor organisation
Royal United Hospitals Bath NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 28 days
Research summary
Summary of Research
Major surgery induces a stress response that increases oxygen demand in tissues. Individuals with higher cardiorespiratory fitness are able to supply the increased oxygen demand in tissues, and are considered ‘lower risk’ for postoperative complications compared to individuals with lower fitness. As such, exercise training prior to surgery – termed ‘prehabilitation’ – is recommended to increase cardiorespiratory fitness and minimise surgical complications. Typically, prehabilitation is delivered via face-to-face programmes which places travel and time burden on patients. Alternatively, traditional home-based programmes may reduce patient burden, but are less engaging and not progressive or personalised. To maximise the potential benefits of prehabilitation, an accessible and effective intervention is required.PreActiv has developed a digital prehabilitation platform where patients can access tailored, progressive, dynamic, evidence-based prehabilitation programmes from their home. Prehabilitation programmes include aerobic, resistance, and breathing exercises selected based on the participant’s fitness and mobility, plus access to peer support and healthcare providers via a community forum. The feasibility and acceptability of PreActiv’s digital prehabiliation requires investigation.
This pilot study will evaluate the recruitment, adherence, compliance, retention, safety, and acceptability of PreActiv’s digital prehabilitation for patients awaiting major elective surgery at the Royal United Hospitals Bath NHS Foundation Trust (RUH). Patients aged ≥50 years and free from contraindications to exercise training will be allocated to receive PreActiv’s digital prehabilitation + usual care for six weeks. The primary aim is to assess whether progression to a larger study is indicated based on pre-defined criteria for adherence and retention. Key secondary aims will be addressed with measurements of cardiorespiratory and functional fitness, resting blood pressure and heart rate, quality of life, mood, and physical activity level taken before and after the intervention period at the University of Bath. The study is funded by a ‘research capability fund’ grant awarded by RUH.
Summary of Results
BACKGROUND & AIMSPast research shows that improving your fitness before major surgery through exercise and lifestyle changes, called prehabilitation, can speed up recovery. Based on this evidence, NHS England published a guideline which requires NHS hospitals to prehabilitate all high-risk adult patients awaiting major surgery, like hysterectomy or joint replacement. Current formats for delivering prehabilitation are either effective but expensive and hard to access (when delivered face-to-face at the hospital) or cheaper and easier to access but less effective (when delivered via generic paper handouts).
PreActiv is a new online prehabilitation programme that can be followed at home at any time, which could be a cost-effective and accessible way of improving fitness before surgery. PreActiv creates exercise programmes that are personalised to the capabilities of the patient, and progress based on fitness tests that are done within the programme. PreActiv also provides educational content on diet, smoking, alcohol, and mindfulness, and a community forum for connection with other patients preparing to have major surgery. The aim of this study was to investigate whether PreActiv was feasible and acceptable for patients preparing for major surgery.
METHODS
The study was done at the Royal United Hospitals Bath NHS Foundation Trust, which was the Sponsor of the study, and provided funding for this work. Participants were invited to take part in the study at their preoperative assessment appointment. Participants were aged 50 years or older and had a minimum of 10 weeks until surgery. If participants had medical conditions which made home exercise unsafe, didn't have access to technology, or were already physically active, they were not eligible to take part. Measurements of fitness and wellbeing were done at the University of Bath before and after the PreActiv programme. Data was collected for this study from February to September 2024.
The primary measurements to evaluate feasibility were retention and adherence percentages, which were compared to criteria defined before the study as: unacceptable (0-50%), acceptable with modifications (51-74%), and ideal (75-100%). Other measurements were: uptake, compliance, safety, and acceptability. Definitions of feasibility measurements are as follows:
Recruitment rate: the percentage of patients who were invited to take part that consented to take part in the study.
Retention rate: the percentage of participants who consented to take part in the study that completed follow-up measurements. We also reported the percentage of patients who started prehabilitation that completed follow-up measurements.
Adherence rate: the percentage of participants who completed all 18 exercise sessions in their programme. We also reported the percentage of total sessions available that were completed.
Compliance rate: the percentage of exercise sessions that were completed at the recommended intensity, duration, and type of exercise.
Safety: the occurrence of medical issues or injuries, and whether they were related to participation in the study.
Acceptability: participant feedback on their experiences of PreActiv provided in anonymous written surveys.
RESULTS
There were 65 patients who were invited to take part, and 35 of those agreed to take part in the study by providing their informed consent. This makes the recruitment rate 54%. A common reason for deciding not to take part was the requirement to attend two university visits for measurements. This finding indicates that travelling to appointments was a barrier for these patients, and should be avoided in future studies. Other patients were not interested in being involved in the study but provided no further information, and it could have been that low confidence with digital technology stopped some patients taking part.
Of the 35 participants who enrolled onto the study, 24 participants completed the follow-up measurements after the PreActiv programme. This makes the retention rate 69% which was in the 'acceptable with modifications' range of 51-74%. Once onboarded on to the PreActiv intervention, retention rate increased to 86%. Retention could be improved in future by tailoring exercise programmes to the patient's surgery date, as some patients exited the study early to have surgery before the original planned date. Again, removing the need for university visits could also improve retention rates, as many people found this to be a barrier. The 24 participants who completed the study were aged 69 years old on average, there were 14 females and 10 males, who all identified their ethnicity as White British. The most common type of surgery was knee or hip replacement.
Of the 24 participants who completed the study, 88% completed all exercise sessions in their programme, which was within the 'ideal' range for adherence rate of 75-100%. Across all participants combined, 98% of exercise sessions available were completed. The high adherence rate might be explained by the individualised nature of exercise sessions and the option to perform them at any time to accommodate the patient's schedule.
The compliance rate was 78%, which means that over three-quarters of exercise sessions done online via PreActiv were performed at the recommended intensity, duration, and type of exercise. Of note, participants were able to consistently exercise at high intensities without supervision from an exercise instructor, and without any medical issues or injuries related to taking part in the PreActiv programme.
Participants found PreActiv acceptable, describing it as enjoyable and worthwhile. Participants expressed frustration when the programme ended before their surgery date, because they were worried about losing any benefits they had gained from participating. Feedback showed that support was excellent when technical challenges were encountered, and that practical and health-related factors sometimes interfered with programme engagement. All participants agreed that they would recommend the programme to a friend if they were having surgery.
Fitness and wellbeing measures taken before and after PreActiv at the University of Bath were only used to look for signs that PreActiv might be effective. The number of participants is too small to make firm conclusions, so a larger study is needed. Fitness measured by a simple 1-minute sit-to-stand test increased by 42%. Fitness measured by a complex cycling test (cardiopulmonary exercise test) was unchanged, but five participants increased a key marker of fitness, called ventilatory threshold, which is linked to improved treatment outcomes. Wellbeing measured using the EQ-5D quality of life 0-100 scale improved from 70 to 80 points. Anxiety and depression scores both improved by 1 point.
CONCLUSION
This study showed that PreActiv is feasible and acceptable to patients awaiting major surgery, and a larger study is warranted to explore the effects of PreActiv on surgical outcomes. The larger study should avoid in-person measurement visits, and should tailor programmes to the patient's surgery date to improve recruitment, retention, and patient satisfaction.
REC name
Wales REC 2
REC reference
24/WA/0007
Date of REC Opinion
25 Jan 2024
REC opinion
Further Information Favourable Opinion