Virtually Monitored Home-Based Prehabilitation Program
Virtually Monitored Home-Based Prehabilitation Program: A multimodal, home-based prehabilitation program delivered via the CloudDX® virtual platform.
Participants in the intervention group will be given a comprehensive prehabilitation pamphlet including:
1. a prescription for aerobic and strength exercises to be completed each week
2. nutritional counselling
3. descriptions of mindfulness deep breathing exercises
4. 36 Premier Protein shakes
The participants will complete baseline questionnaires and receive prehabilitation consultation and education after onboarding to the CloudDX virtual platform using a cellular-enabled tablet provided to them, or their own device.
Study summary
The goal of this clinical trial is to learn if a virtually monitored, home-based prehabilitation program is feasible and acceptable for adults undergoing major elective surgery. The main questions it aims to answer are:
1. Can researchers successfully recruit and retain participants across multiple sites?
2. Will participants adhere to the prehabilitation program at a high enough rate to justify a larger trial?
Researchers will compare the prehabilitation program to standard preoperative care to see if the intervention is feasible to implement and whether it may help reduce postoperative complications.
Participants will:
* Be randomly assigned to receive either the prehabilitation program or usual care
* Complete questionnaires and physical assessments before and after the intervention
* (For those in the intervention group) Receive exercise, nutrition, and mindfulness guidance, protein supplements, and use the CloudDX virtual care platform to support their activities
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* ≥ 18 years of age
* Undergoing major elective intra-thoracic, intra-abdominal or orthopedic surgery. Major surgery is defined as any operation performed under general and/or spinal anesthesia requiring a skin incision extending beyond the subcutaneous tissue
* More than 3 weeks from the date of scheduled operation
Exclusion Criteria:
* Emergency Surgery
* Operation in less than 3 weeks from time of initial research contact
* Patients who are pregnant
* Unable/unwilling to sign written informed consent
* Physical, cognitive or psychological impairment
* Unable to understand/communication in English.
Primary outcome measure(s)
Feasibility of recruiting patients in a timely manner across local and outside sites — From the start to end of patient recruitment (2 years) We will aim for a patient recruitment rate of 20 patients per month. A recruitment rate of greater than 10 but less than 20 patients per month will be considered feasible with modifications for the definitive study.
Feasibility outcomes will be assessed according to the traffic light system. If the results fall within the 'green light' range, the definitive study will proceed as planned. Any results falling into the 'yellow light' range will require review and changes to the protocol before proceeding to the definitive phase. If results fall within the 'red light' range, the study will be considered not feasible without major modifications.
Adherence with virtually monitored home-based prehabilitation program — From enrolment to the day of scheduled surgery (3 week timespan) Adherence will be monitored through the CloudDX activity tracker completed by the study participants. The number of interventions completed will be divided by the number of interventions prescribed to calculate the percent adherence to the overall prehabilitation program. If the mean reported adherence is greater than 80% with an associated lower bound of a 95% CIs of greater than 65%, this will support the feasibility of a definitive study. A mean adherence of greater than 60% (and associated lower bound of a 95% CIs of greater than 50%) but less than 80% will be considered feasible with modifications for the definitive study.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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