Trial Outcomes & Findings for Digital Prehabilitation for Patients Undergoing Major Elective Surgery (NCT NCT06137781)
NCT ID: NCT06137781
Last Updated: 2025-12-17
Results Overview
The number of patients invited that provide written informed consent, with percentage calculated
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
4 months
Results posted on
2025-12-17
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Baseline measurements
STARTED
|
35
|
|
Baseline measurements
COMPLETED
|
31
|
|
Baseline measurements
NOT COMPLETED
|
4
|
|
Intervention period
STARTED
|
31
|
|
Intervention period
Commenced intervention
|
28
|
|
Intervention period
COMPLETED
|
24
|
|
Intervention period
NOT COMPLETED
|
7
|
|
Follow-up measurements
STARTED
|
24
|
|
Follow-up measurements
COMPLETED
|
24
|
|
Follow-up measurements
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Baseline measurements
Lost to Follow-up
|
2
|
|
Baseline measurements
Withdrawal by Subject
|
1
|
|
Baseline measurements
Expedited surgery
|
1
|
|
Intervention period
Lost to Follow-up
|
2
|
|
Intervention period
Withdrawal by Subject
|
3
|
|
Intervention period
Expedited surgery
|
1
|
|
Intervention period
Adverse Event
|
1
|
Baseline Characteristics
Digital Prehabilitation for Patients Undergoing Major Elective Surgery
Baseline characteristics by cohort
| Measure |
Six Weeks of Digital Prehabilitation
n=24 Participants
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.
|
|---|---|
|
Age, Continuous
|
69 Years
n=6 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White British
|
24 Participants
n=6 Participants
|
|
Surgery type
Knee replacement
|
3 Participants
n=6 Participants
|
|
Surgery type
Hip replacement
|
3 Participants
n=6 Participants
|
|
Surgery type
Parathyroidectomy
|
3 Participants
n=6 Participants
|
|
Surgery type
Hernia repair
|
3 Participants
n=6 Participants
|
|
Surgery type
Thyroidectomy
|
2 Participants
n=6 Participants
|
|
Surgery type
Vaginal prolapse repair
|
2 Participants
n=6 Participants
|
|
Surgery type
Hysterectomy
|
2 Participants
n=6 Participants
|
|
Surgery type
Knee revision
|
1 Participants
n=6 Participants
|
|
Surgery type
Hip revision
|
1 Participants
n=6 Participants
|
|
Surgery type
Cholecystectomy
|
1 Participants
n=6 Participants
|
|
Surgery type
Prostatectomy
|
1 Participants
n=6 Participants
|
|
Surgery type
Ovarian cystectomy
|
1 Participants
n=6 Participants
|
|
Surgery type
Ureteral reimplantation
|
1 Participants
n=6 Participants
|
|
Body mass index
|
29.1 kg/m2
n=6 Participants
|
PRIMARY outcome
Timeframe: 4 monthsThe number of patients invited that provide written informed consent, with percentage calculated
Outcome measures
| Measure |
Six weeks of digital prehabilitation
n=65 Participants
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.
|
|---|---|
|
Number of Participants Recruited
|
35 Participants
|
PRIMARY outcome
Timeframe: 4 monthsThe number of patients invited that are willing to be screened for eligibility, with percentage calculated
Outcome measures
| Measure |
Six weeks of digital prehabilitation
n=65 Participants
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.
|
|---|---|
|
Number of Participants Interested in Participating
|
39 Participants
|
PRIMARY outcome
Timeframe: 4 monthsThe number of willing patients that pass screening for eligibility, with percentage calculated
Outcome measures
| Measure |
Six weeks of digital prehabilitation
n=39 Participants
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.
|
|---|---|
|
Number of Participants That Passed Screening
|
35 Participants
|
PRIMARY outcome
Timeframe: 6 weeksThe number of participants who complete all exercise sessions, with percentage calculated
Outcome measures
| Measure |
Six weeks of digital prehabilitation
n=24 Participants
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.
|
|---|---|
|
Number of Adherent Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: 6 weeksThe percentage of exercise sessions that are completed as prescribed in terms of intensity, duration, and type of exercise
Outcome measures
| Measure |
Six weeks of digital prehabilitation
n=24 Participants
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.
|
|---|---|
|
Percentage of Compliant Exercise Sessions
|
79 Percentage
Interval 68.0 to 90.0
|
PRIMARY outcome
Timeframe: 6 weeksThe number of patients that enrol into the study who complete follow-up measurements, with percentage calculated
Outcome measures
| Measure |
Six weeks of digital prehabilitation
n=35 Participants
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.
|
|---|---|
|
Number of Participants Retained
|
24 Participants
|
SECONDARY outcome
Timeframe: Change from pre-intervention (week 0) to post-intervention (week 7)Population: 21/24 participants completed cardiopulmonary exercise testing.
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.
Outcome measures
| Measure |
Six weeks of digital prehabilitation
n=21 Participants
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.
|
|---|---|
|
Cardiorespiratory Fitness
Ventilatory threshold (pre-post change)
|
0.0 ml/kg/min
Interval -1.0 to 2.5
|
|
Cardiorespiratory Fitness
Peak oxygen uptake (pre-post change)
|
0.3 ml/kg/min
Interval -0.7 to 1.2
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Six weeks of digital prehabilitation
n=24 Participants
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.
|
|---|---|
|
Resting Blood Pressure
Systolic blood pressure (pre-post change)
|
1 mmHg
Interval -10.0 to 12.0
|
|
Resting Blood Pressure
Diastolic blood pressure (pre-post change)
|
1 mmHg
Interval -3.0 to 5.0
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Six weeks of digital prehabilitation
n=24 Participants
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.
|
|---|---|
|
Resting Heart Rate
|
-2 beats/minute
Interval -7.0 to 4.0
|
SECONDARY outcome
Timeframe: Change from pre-intervention (week 0) to post-intervention (week 7)Population: 20/24 participants provided complete IPAQ-short form responses for calculation of total physical activity.
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.
Outcome measures
| Measure |
Six weeks of digital prehabilitation
n=20 Participants
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.
|
|---|---|
|
Physical Activity Level
|
852 MET-minutes/week
Interval -53.0 to 2292.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Six weeks of digital prehabilitation
n=24 Participants
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.
|
|---|---|
|
Anxiety and Depression
Anxiety (pre-post change)
|
-1 Points
Interval -2.0 to 0.0
|
|
Anxiety and Depression
Depression (pre-post change)
|
-1 Points
Interval -1.0 to 0.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Six weeks of digital prehabilitation
n=24 Participants
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.
|
|---|---|
|
Quality of Life EQ-5D Visual Analogue Scale
|
5 Percentage
Interval 0.0 to 15.0
|
SECONDARY outcome
Timeframe: Change from pre-intervention (week 0) to post-intervention (week 7).Population: 19/24 participants completed 1-minute sit-to-stand testing.
Assessed via the number of repetitions completed during a 1-minute sit-to-stand test.
Outcome measures
| Measure |
Six weeks of digital prehabilitation
n=19 Participants
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.
|
|---|---|
|
1-minute Sit-to-stand Test
|
11 Repetitions
Interval 6.0 to 14.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksAn 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.
Outcome measures
| Measure |
Six weeks of digital prehabilitation
n=24 Participants
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.
|
|---|---|
|
Carbon Emissions Avoided With Home-based vs. Face-to-face Prehabilitation
|
44 Kilograms of carbon emissions avoided
Interval 13.0 to 63.0
|
Adverse Events
Six weeks of digital prehabilitation
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Six weeks of digital prehabilitation
n=35 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Myocardial infarction (onset at work)
|
2.9%
1/35 • From enrollment to end of follow-up, an average of 8 weeks
|
|
Gastrointestinal disorders
Diverticulitis
|
2.9%
1/35 • From enrollment to end of follow-up, an average of 8 weeks
|
Other adverse events
| Measure |
Six weeks of digital prehabilitation
n=35 participants at risk
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.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Infectious illness (e.g., cold/flu)
|
5.7%
2/35 • From enrollment to end of follow-up, an average of 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Injury sustained at work
|
5.7%
2/35 • From enrollment to end of follow-up, an average of 8 weeks
|
|
Nervous system disorders
Flare-up of fibromyalgia
|
2.9%
1/35 • From enrollment to end of follow-up, an average of 8 weeks
|
|
Gastrointestinal disorders
Diverticulitis
|
2.9%
1/35 • From enrollment to end of follow-up, an average of 8 weeks
|
Additional Information
Alec Snow
Royal United Hospitals Bath NHS Foundation Trust
Phone: 07793554479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place