PrehabilitationPRIMENCT07590141
Prehabilitation Before Major Surgery
A study testing Virtually Monitored Home-Based Prehabilitation Program in people with Prehabilitation and Preoperative Care, run by Queen's University at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prehabilitation, Preoperative Care, Elective Surgical Procedures
- What is being tested?
- Virtually Monitored Home-Based Prehabilitation Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Jun 2026to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Cagla Eskicioglu, MD, MSc, FRCSC, FASCRS, 905-522-1155 ext. 35921, eskicio@mcmaster.ca
Cagla Eskicioglu, MD, MSc, FRCSC, FASCRS
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Deborah DuMerton, 613-484-7322, Deborah.DuMerton@Kingstonhsc.ca
Rachel Phelan, 613-548-7827, Rachel.Phalen@Kingstonhsc.ca
The Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y 4E9
Daniel McIsaac, MD, MSc, FRCPC, 613-761-4395, dmcisaac@toh.ca
Daniel McIsaac, MD, MSc, FRCPC
About this study
Official title: PRehabilitation In Advance of Major Elective Surgery: A Pilot Randomized Controlled Trial (PRIME Pilot)
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:
- Can researchers successfully recruit and retain participants across multiple sites?
- Will participants adhere to the prehabilitation program at a high enough rate to justify a larger trial?
Read more
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
Read the detailed description
The PRIME pilot trial aims to investigate whether a virtually monitored, home-based multimodal prehabilitation is feasible and can improve postoperative outcomes in adult patient populations undergoing major elective intra-thoracic, intra-abdominal, or orthopedic surgery.
The goal of a prehabilitation program is to optimize a patient's health status before surgery to reduce postoperative morbidity and enhance recovery. Despite advances in perioperative care, postoperative morbidity remains high, particularly in frail, obese, or older populations. Multimodal prehabilitation which includes physical exercise, nutritional optimization, and psychological support has demonstrated potential benefits in small trials and feasibility studies, yet definitive evidence remains limited. Intensive in-person prehabilitation, though effective, is not feasible for most centers due to resource limitations. Conversely, home-based programs, while pragmatic, have shown inconsistent adherence and outcomes. This study proposes a virtually monitored, home-based multimodal prehabilitation program designed to balance feasibility, adherence, and effectiveness, using the CloudDX® remote monitoring platform. The program includes exercise prescriptions, nutritional support, mindfulness exercises, and participant accountability through app-based monitoring.
The study will be conducted as a multicenter pilot randomized controlled trial at Kingston Health Sciences Centre, The Ottawa Hospital, and Hamilton Health Sciences. A total of 120 adult patients scheduled for major elective intra-thoracic, intra-abdominal, or orthopedic surgery will be randomized 1:1 to receive either standard preoperative care or the multimodal prehabilitation intervention. Participants in the intervention group 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. The structured prehabilitation activities will be completed over a minimum of three weeks before surgery.
Primary objectives focus on feasibility, specifically recruitment rates and adherence to the intervention. Adherence will be tracked via the CloudDX® platform. Secondary objectives include assessing the program's impact on postoperative complications (using the Comprehensive Complication Index), mortality, disability (WHODAS 2.0), length of hospital stay, readmission rates, functional capacity (6-Minute Walk Test, CHAMPS, grip strength), quality of life (EQ-5D-5L), and nutritional status (PG-SGA).
Data will be collected through patient interaction, app-based monitoring, and medical record review. All study personnel will receive standardized training, and a detailed Manual of Operations will guide procedures at all sites. Data will be entered into a secure, REDCap electronic database using study-specific IDs, with source documents retained for verification. To ensure data quality, the Project Office will review monthly reports on enrollment, follow-up, and data completeness. The database will have built-in validity and range checks, with multi-level data validation and regular quality control reports shared with sites. All study records will be stored securely for at least five years post-study, with controlled access. Additionally, case histories with records of all observations and data related to the investigation will be maintained for each participant. Data will be reported on a hard copy case report form as well as being entered onto online database.
Descriptive statistics (means, medians, standard deviations, interquartile ranges, proportions) will be used to characterize the study sample. The outcomes of the pilot study will be descriptive in nature and will focus on feasibility measures, including recruitment, adherence, case report form completion, patient satisfaction, and withdrawal rates. Binary outcomes will be summarized using proportions with corresponding 95% confidence intervals. Differences in continuous outcomes will be described using the difference in means with corresponding 95% confidence intervals. All analyses will follow intent-to-treat (ITT) principles, with the ITT population defined as all randomized participants. Baseline characteristics will be summarized descriptively.
The study will be conducted in compliance with the protocol, principles laid down in the Declaration of Helsinki, Good Clinical Practice (GCP), as defined by the International Conference on Harmonisation (ICH), and all applicable laws and regulations of Canada.
By addressing the critical gap in accessible prehabilitation services, this trial aims to establish a scalable model that can be integrated across Canadian healthcare settings. The results of this pilot will inform the design and conduct of a larger definitive randomized trial.
- Conditions
- Prehabilitation, Preoperative Care, Elective Surgical Procedures, Postoperative Complications, Surgical Procedures, Operative
- Being tested
- Virtually Monitored Home-Based Prehabilitation Program
- Keywords
- Home-based Care, Virtual Care, Remote Health Monitoring, Exercise Therapy, Nutritional Support, Psychological Support, Postoperative Outcomes
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtually Monitored Home-Based Prehabilitation ProgramBehavioural
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:
- a prescription for aerobic and strength exercises to be completed each week
- nutritional counselling
- descriptions of mindfulness deep breathing exercises
- 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 group | Role | What they receive |
|---|---|---|
| Prehabilitation Program | Experimental | Participants in this arm will receive a home-based, virtually monitored multimodal prehabilitation program. The intervention includes aerobic and strength exercise prescriptions, nutritional counseling, mindfulness breathing exercises, and 36 Premier Protein® shakes. Participants will use the CloudDX® virtual care platform via a provided tablet or their own device to support adherence and track progress. Receives: Behavioral: Virtually Monitored Home-Based Prehabilitation Program |
| Preoperative Standard of Care | No intervention | Participants in this arm will receive standard preoperative care as per current clinical practice. They will not receive any structured prehabilitation components during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruiting patients in a timely manner across local and outside sites
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.
Measured: From the start to end of patient recruitment (2 years)
Adherence with virtually monitored home-based prehabilitation program
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.
Measured: From enrolment to the day of scheduled surgery (3 week timespan)
Secondary outcomes (14)
Postoperative complications
30-day CCI will be used. This is a scoring system used to quantify the overall burden of postoperative complications. It consolidates multiple complications into a single score ranging from 0 (no complications) to 100 (death). Each complication is weighted based on severity and impact, providing a cumulative measure that reflects the total morbidity a patient experiences. A severe postoperative complication will be defined as a CCI score of 20 or more. All complications occurring within 30 days of the index operation will be included in the CCI calculation.
Measured: 30 days post-surgery
Mortality
30-day Postoperative Mortality: Death from any cause occurring within 30-days of the index operation.
Measured: 30 days post-surgery
Disability
30-day patient-reported disability: This will be assessed using the WHO Disability Assessment Schedule V.2.0 (WHODAS).
Measured: 30 days post-surgery
Length of stay and readmission
Postoperative Length of Stay (LOS): Postoperative LOS will be calculated as the number of days following the index surgery (i.e., postoperative day 0) that the patient remains in hospital. Every morning that the patient remains in hospital will count as an added day to postoperative LOS.
30-day Readmission: Following discharge from their index postoperative stay, if a patient is readmitted to any hospital for any reason within 30-days of their index operation, this will be counted as an outcome event. Reason for readmission will be recorded.
Measured: Length of stay: From day of surgery to date of documented discharge, assessed up to 30-days after surgery. Readmission: From day of surgery until date of first documented hospital readmission, assessed up to 30-days post-surgery
European Quality of Life 5 Dimensions 5 Level Version (EQ5D5L)
Assessed using the European Quality of Life 5 Dimensions 5 Level Version (EQ5D5L). This questionnaire measures five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-each with 5 severity levels (1=No problem, 5=Extreme problem). It is then scored by creating 5-digit health profiles (e.g., 11111 = No problem for all dimensions).
Measured: Assessed at each major assessment point throughout the study. (1) Baseline - Day 0 (2) 2 days prior to surgery (3) 30 days after surgery
Nutritional Status
Assessed with the Patient-Generated Subjective Global Assessment (PG-SGA).
Measured: Assessed at each major assessment point throughout the study. (1) Baseline - Day 0 (2) 2 days prior to surgery (3) 30 days after surgery
Percentage of patients approached that are subsequently enrolled
The proportion of eligible patients approached for study participation who provide informed consent and are successfully enrolled in the study.
Measured: From initial patient approach until enrolment is completed
Case Report Form Completion
The percentage of case report forms for enrolled patients that are completed in their entirety without missing data, based on pre-specified required data elements.
Measured: From enrolment until final data entry for each participant.
Patient Satisfaction With Prehabilitation Program
The percentage of participants randomized to the prehabilitation group who report that they would enrol in the program again.
Measured: After the 3 week prehabilitation program; before surgery
Proportion of Participants Who Withdraw Consent to Participate
The proportion of participants who withdraw consent for any reason after enrolment and prior to study completion.
Measured: From enrolment until final study follow-up (30 days postoperative).
6-Minute Walk Test Distance
Maximal distance achieved during the 6-minute walk test in metres.
Measured: (1) Baseline (2) 2-days prior to surgery (3) 30-days after surgery
Self-reported physical activity
Assessed using the Community Healthy Activities Model Program for Seniors (CHAMPS) survey.
Measured: (1) baseline (2) 2-days prior to surgery (3) 30-days after surgery
Hand Grip Strength
Peak hand grip strength in kilograms measured by a hand dynamometer.
Measured: (1) Baseline (2) 2-days before surgery (3) 30-days after surgery
Leg strength
Dominant leg strength will be assessed using a HUMAC NORM Dynamometer. The peak torque recorded after three attempts will be presented as leg strength (in newton-meters).
Measured: (1) Baseline (2) 2-days before surgery (3) 30-days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for PrehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned via web-based randomization system in a 1:1 ratio to one of two groups: a virtually monitored, home-based prehabilitation intervention group or a usual care control group. Participants remain in their assigned group for the duration of the study.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Anesthesia Research Foundation, Ottawa Hospital Research Institute, Kingston Health Sciences Centre, Hamilton Health Sciences Centre, St. Joseph's Healthcare Hamilton
- Responsible party
- Principal investigator, Jordan Leitch, Queen's University
- Investigators
- Jordan Leitch, MSc, MD, FRCPC, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590141
- Sponsor's protocol ID
- PRIME Pilot
- Acronym
- PRIME
- Status last verified
- May 2026
- First submitted
- 27 Feb 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.
PubMed 27777223Bauer J, Capra S, Ferguson M. Use of the scored Patient-Generated Subjective Global Assessment (PG-SGA) as a nutrition assessment tool in patients with cancer. Eur J Clin Nutr. 2002 Aug;56(8):779-85. doi: 10.1038/sj.ejcn.1601412.
PubMed 12122555Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
PubMed 21479777Ustun TB, Chatterji S, Kostanjsek N, Rehm J, Kennedy C, Epping-Jordan J, Saxena S, von Korff M, Pull C; WHO/NIH Joint Project. Developing the World Health Organization Disability Assessment Schedule 2.0. Bull World Health Organ. 2010 Nov 1;88(11):815-23. doi: 10.2471/BLT.09.067231. Epub 2010 May 20.
PubMed 21076562Laporte M, Keller HH, Payette H, Allard JP, Duerksen DR, Bernier P, Jeejeebhoy K, Gramlich L, Davidson B, Vesnaver E, Teterina A. Validity and reliability of the new Canadian Nutrition Screening Tool in the 'real-world' hospital setting. Eur J Clin Nutr. 2015 May;69(5):558-64. doi: 10.1038/ejcn.2014.270. Epub 2014 Dec 17.
PubMed 25514899Grevitt M, Khazim R, Webb J, Mulholland R, Shepperd J. The short form-36 health survey questionnaire in spine surgery. J Bone Joint Surg Br. 1997 Jan;79(1):48-52. doi: 10.1302/0301-620x.79b1.1269.
PubMed 9020444McIsaac DI, Hladkowicz E, Bryson GL, Forster AJ, Gagne S, Huang A, Lalu M, Lavallee LT, Moloo H, Nantel J, Power B, Scheede-Bergdahl C, van Walraven C, McCartney CJL, Taljaard M. Home-based prehabilitation with exercise to improve postoperative recovery for older adults with frailty having cancer surgery: the PREHAB randomised clinical trial. Br J Anaesth. 2022 Jul;129(1):41-48. doi: 10.1016/j.bja.2022.04.006. Epub 2022 May 17.
PubMed 35589429Martin D, Besson C, Pache B, Michel A, Geinoz S, Gremeaux-Bader V, Larcinese A, Benaim C, Kayser B, Demartines N, Hubner M. Feasibility of a prehabilitation program before major abdominal surgery: a pilot prospective study. J Int Med Res. 2021 Nov;49(11):3000605211060196. doi: 10.1177/03000605211060196.
PubMed 34851778Chmelo J, Phillips AW, Greystoke A, Charman SJ, Avery L, Hallsworth K, Welford J, Cooper M, Sinclair RCF. A feasibility trial of prehabilitation before oesophagogastric cancer surgery using a multi-component home-based exercise programme: the ChemoFit study. Pilot Feasibility Stud. 2022 Aug 9;8(1):173. doi: 10.1186/s40814-022-01137-6.
PubMed 35945625Bojesen RD, Jorgensen LB, Grube C, Skou ST, Johansen C, Dalton SO, Gogenur I. Fit for Surgery-feasibility of short-course multimodal individualized prehabilitation in high-risk frail colon cancer patients prior to surgery. Pilot Feasibility Stud. 2022 Jan 21;8(1):11. doi: 10.1186/s40814-022-00967-8.
PubMed 35063042Molenaar CJL, Minnella EM, Coca-Martinez M, Ten Cate DWG, Regis M, Awasthi R, Martinez-Palli G, Lopez-Baamonde M, Sebio-Garcia R, Feo CV, van Rooijen SJ, Schreinemakers JMJ, Bojesen RD, Gogenur I, van den Heuvel ER, Carli F, Slooter GD; PREHAB Study Group. Effect of Multimodal Prehabilitation on Reducing Postoperative Complications and Enhancing Functional Capacity Following Colorectal Cancer Surgery: The PREHAB Randomized Clinical Trial. JAMA Surg. 2023 Jun 1;158(6):572-581. doi: 10.1001/jamasurg.2023.0198.
PubMed 36988937Gillis C, Fenton TR, Sajobi TT, Minnella EM, Awasthi R, Loiselle SE, Liberman AS, Stein B, Charlebois P, Carli F. Trimodal prehabilitation for colorectal surgery attenuates post-surgical losses in lean body mass: A pooled analysis of randomized controlled trials. Clin Nutr. 2019 Jun;38(3):1053-1060. doi: 10.1016/j.clnu.2018.06.982. Epub 2018 Jul 9.
PubMed 30025745Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.
PubMed 23052535McIsaac DI, Gill M, Boland L, Hutton B, Branje K, Shaw J, Grudzinski AL, Barone N, Gillis C; Prehabilitation Knowledge Network. Prehabilitation in adult patients undergoing surgery: an umbrella review of systematic reviews. Br J Anaesth. 2022 Feb;128(2):244-257. doi: 10.1016/j.bja.2021.11.014. Epub 2021 Dec 16.
PubMed 34922735Schoenfeld AJ, Serrano JA, Waterman BR, Bader JO, Belmont PJ Jr. The impact of resident involvement on post-operative morbidity and mortality following orthopaedic procedures: a study of 43,343 cases. Arch Orthop Trauma Surg. 2013 Nov;133(11):1483-91. doi: 10.1007/s00402-013-1841-3. Epub 2013 Sep 1.
PubMed 23995548
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRehabilitation In Advance of Major Elective Surgery: A Pilot Randomized Controlled Trial (PRIME Pilot)
- ClinicalTrials.gov ID
- NCT07590141
- Acronym / sponsor ID
- PRIME / PRIME Pilot
- Conditions
- Prehabilitation, Preoperative Care, Elective Surgical Procedures, Postoperative Complications, Surgical Procedures, Operative
- Keywords
- Home-based Care, Virtual Care, Remote Health Monitoring, Exercise Therapy, Nutritional Support, Psychological Support, Postoperative Outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Canadian Anesthesia Research Foundation, Ottawa Hospital Research Institute, Kingston Health Sciences Centre, Hamilton Health Sciences Centre, St. Joseph's Healthcare Hamilton
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can researchers successfully recruit and retain participants across multiple sites?
- 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
Detailed description
The PRIME pilot trial aims to investigate whether a virtually monitored, home-based multimodal prehabilitation is feasible and can improve postoperative outcomes in adult patient populations undergoing major elective intra-thoracic, intra-abdominal, or orthopedic surgery.
The goal of a prehabilitation program is to optimize a patient's health status before surgery to reduce postoperative morbidity and enhance recovery. Despite advances in perioperative care, postoperative morbidity remains high, particularly in frail, obese, or older populations. Multimodal prehabilitation which includes physical exercise, nutritional optimization, and psychological support has demonstrated potential benefits in small trials and feasibility studies, yet definitive evidence remains limited. Intensive in-person prehabilitation, though effective, is not feasible for most centers due to resource limitations. Conversely, home-based programs, while pragmatic, have shown inconsistent adherence and outcomes. This study proposes a virtually monitored, home-based multimodal prehabilitation program designed to balance feasibility, adherence, and effectiveness, using the CloudDX® remote monitoring platform. The program includes exercise prescriptions, nutritional support, mindfulness exercises, and participant accountability through app-based monitoring.
The study will be conducted as a multicenter pilot randomized controlled trial at Kingston Health Sciences Centre, The Ottawa Hospital, and Hamilton Health Sciences. A total of 120 adult patients scheduled for major elective intra-thoracic, intra-abdominal, or orthopedic surgery will be randomized 1:1 to receive either standard preoperative care or the multimodal prehabilitation intervention. Participants in the intervention group 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. The structured prehabilitation activities will be completed over a minimum of three weeks before surgery.
Primary objectives focus on feasibility, specifically recruitment rates and adherence to the intervention. Adherence will be tracked via the CloudDX® platform. Secondary objectives include assessing the program's impact on postoperative complications (using the Comprehensive Complication Index), mortality, disability (WHODAS 2.0), length of hospital stay, readmission rates, functional capacity (6-Minute Walk Test, CHAMPS, grip strength), quality of life (EQ-5D-5L), and nutritional status (PG-SGA).
Data will be collected through patient interaction, app-based monitoring, and medical record review. All study personnel will receive standardized training, and a detailed Manual of Operations will guide procedures at all sites. Data will be entered into a secure, REDCap electronic database using study-specific IDs, with source documents retained for verification. To ensure data quality, the Project Office will review monthly reports on enrollment, follow-up, and data completeness. The database will have built-in validity and range checks, with multi-level data validation and regular quality control reports shared with sites. All study records will be stored securely for at least five years post-study, with controlled access. Additionally, case histories with records of all observations and data related to the investigation will be maintained for each participant. Data will be reported on a hard copy case report form as well as being entered onto online database.
Descriptive statistics (means, medians, standard deviations, interquartile ranges, proportions) will be used to characterize the study sample. The outcomes of the pilot study will be descriptive in nature and will focus on feasibility measures, including recruitment, adherence, case report form completion, patient satisfaction, and withdrawal rates. Binary outcomes will be summarized using proportions with corresponding 95% confidence intervals. Differences in continuous outcomes will be described using the difference in means with corresponding 95% confidence intervals. All analyses will follow intent-to-treat (ITT) principles, with the ITT population defined as all randomized participants. Baseline characteristics will be summarized descriptively.
The study will be conducted in compliance with the protocol, principles laid down in the Declaration of Helsinki, Good Clinical Practice (GCP), as defined by the International Conference on Harmonisation (ICH), and all applicable laws and regulations of Canada.
By addressing the critical gap in accessible prehabilitation services, this trial aims to establish a scalable model that can be integrated across Canadian healthcare settings. The results of this pilot will inform the design and conduct of a larger definitive randomized trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned via web-based randomization system in a 1:1 ratio to one of two groups: a virtually monitored, home-based prehabilitation intervention group or a usual care control group. Participants remain in their assigned group for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation Program | Experimental | Behavioral: Virtually Monitored Home-Based Prehabilitation ProgramParticipants in this arm will receive a home-based, virtually monitored multimodal prehabilitation program. The intervention includes aerobic and strength exercise prescriptions, nutritional counseling, mindfulness breathing exercises, and 36 Premier Protein® shakes. Participants will use the CloudDX® virtual care platform via a provided tablet or their own device to support adherence and track progress. |
| Preoperative Standard of Care | No intervention | –Participants in this arm will receive standard preoperative care as per current clinical practice. They will not receive any structured prehabilitation components during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtually Monitored Home-Based Prehabilitation ProgramA 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. | Behavioural | Prehabilitation Program |
Primary outcome
Feasibility of recruiting patients in a timely manner across local and outside sites
Time frame: 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
Time frame: 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.
14 secondary outcomes
Postoperative complications
Time frame: 30 days post-surgery
Mortality
Time frame: 30 days post-surgery
Disability
Time frame: 30 days post-surgery
Length of stay and readmission
Time frame: Length of stay: From day of surgery to date of documented discharge, assessed up to 30-days after surgery. Readmission: From day of surgery until date of first documented hospital readmission, assessed up to 30-days post-surgery
European Quality of Life 5 Dimensions 5 Level Version (EQ5D5L)
Time frame: Assessed at each major assessment point throughout the study. (1) Baseline - Day 0 (2) 2 days prior to surgery (3) 30 days after surgery
Nutritional Status
Time frame: Assessed at each major assessment point throughout the study. (1) Baseline - Day 0 (2) 2 days prior to surgery (3) 30 days after surgery
Percentage of patients approached that are subsequently enrolled
Time frame: From initial patient approach until enrolment is completed
Case Report Form Completion
Time frame: From enrolment until final data entry for each participant.
Patient Satisfaction With Prehabilitation Program
Time frame: After the 3 week prehabilitation program; before surgery
Proportion of Participants Who Withdraw Consent to Participate
Time frame: From enrolment until final study follow-up (30 days postoperative).
6-Minute Walk Test Distance
Time frame: (1) Baseline (2) 2-days prior to surgery (3) 30-days after surgery
Self-reported physical activity
Time frame: (1) baseline (2) 2-days prior to surgery (3) 30-days after surgery
Hand Grip Strength
Time frame: (1) Baseline (2) 2-days before surgery (3) 30-days after surgery
Leg strength
Time frame: (1) Baseline (2) 2-days before surgery (3) 30-days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 27777223Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.
- Background: PubMed 12122555Bauer J, Capra S, Ferguson M. Use of the scored Patient-Generated Subjective Global Assessment (PG-SGA) as a nutrition assessment tool in patients with cancer. Eur J Clin Nutr. 2002 Aug;56(8):779-85. doi: 10.1038/sj.ejcn.1601412.
- Background: PubMed 21479777Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
- Background: PubMed 21076562Ustun TB, Chatterji S, Kostanjsek N, Rehm J, Kennedy C, Epping-Jordan J, Saxena S, von Korff M, Pull C; WHO/NIH Joint Project. Developing the World Health Organization Disability Assessment Schedule 2.0. Bull World Health Organ. 2010 Nov 1;88(11):815-23. doi: 10.2471/BLT.09.067231. Epub 2010 May 20.
- Background: PubMed 25514899Laporte M, Keller HH, Payette H, Allard JP, Duerksen DR, Bernier P, Jeejeebhoy K, Gramlich L, Davidson B, Vesnaver E, Teterina A. Validity and reliability of the new Canadian Nutrition Screening Tool in the 'real-world' hospital setting. Eur J Clin Nutr. 2015 May;69(5):558-64. doi: 10.1038/ejcn.2014.270. Epub 2014 Dec 17.
- Background: PubMed 9020444Grevitt M, Khazim R, Webb J, Mulholland R, Shepperd J. The short form-36 health survey questionnaire in spine surgery. J Bone Joint Surg Br. 1997 Jan;79(1):48-52. doi: 10.1302/0301-620x.79b1.1269.
- Background: PubMed 35589429McIsaac DI, Hladkowicz E, Bryson GL, Forster AJ, Gagne S, Huang A, Lalu M, Lavallee LT, Moloo H, Nantel J, Power B, Scheede-Bergdahl C, van Walraven C, McCartney CJL, Taljaard M. Home-based prehabilitation with exercise to improve postoperative recovery for older adults with frailty having cancer surgery: the PREHAB randomised clinical trial. Br J Anaesth. 2022 Jul;129(1):41-48. doi: 10.1016/j.bja.2022.04.006. Epub 2022 May 17.
- Background: PubMed 34851778Martin D, Besson C, Pache B, Michel A, Geinoz S, Gremeaux-Bader V, Larcinese A, Benaim C, Kayser B, Demartines N, Hubner M. Feasibility of a prehabilitation program before major abdominal surgery: a pilot prospective study. J Int Med Res. 2021 Nov;49(11):3000605211060196. doi: 10.1177/03000605211060196.
- Background: PubMed 35945625Chmelo J, Phillips AW, Greystoke A, Charman SJ, Avery L, Hallsworth K, Welford J, Cooper M, Sinclair RCF. A feasibility trial of prehabilitation before oesophagogastric cancer surgery using a multi-component home-based exercise programme: the ChemoFit study. Pilot Feasibility Stud. 2022 Aug 9;8(1):173. doi: 10.1186/s40814-022-01137-6.
- Background: PubMed 35063042Bojesen RD, Jorgensen LB, Grube C, Skou ST, Johansen C, Dalton SO, Gogenur I. Fit for Surgery-feasibility of short-course multimodal individualized prehabilitation in high-risk frail colon cancer patients prior to surgery. Pilot Feasibility Stud. 2022 Jan 21;8(1):11. doi: 10.1186/s40814-022-00967-8.
- Background: PubMed 36988937Molenaar CJL, Minnella EM, Coca-Martinez M, Ten Cate DWG, Regis M, Awasthi R, Martinez-Palli G, Lopez-Baamonde M, Sebio-Garcia R, Feo CV, van Rooijen SJ, Schreinemakers JMJ, Bojesen RD, Gogenur I, van den Heuvel ER, Carli F, Slooter GD; PREHAB Study Group. Effect of Multimodal Prehabilitation on Reducing Postoperative Complications and Enhancing Functional Capacity Following Colorectal Cancer Surgery: The PREHAB Randomized Clinical Trial. JAMA Surg. 2023 Jun 1;158(6):572-581. doi: 10.1001/jamasurg.2023.0198.
- Background: PubMed 30025745Gillis C, Fenton TR, Sajobi TT, Minnella EM, Awasthi R, Loiselle SE, Liberman AS, Stein B, Charlebois P, Carli F. Trimodal prehabilitation for colorectal surgery attenuates post-surgical losses in lean body mass: A pooled analysis of randomized controlled trials. Clin Nutr. 2019 Jun;38(3):1053-1060. doi: 10.1016/j.clnu.2018.06.982. Epub 2018 Jul 9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jordan Leitch, MSc, MD, FRCPC principal investigator
Queen's University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtually Monitored Home-Based Prehabilitation Program in people with Prehabilitation and Preoperative Care, run by Queen's University at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deborah DuMerton (613-484-7322, Deborah.DuMerton@Kingstonhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruiting patients in a timely manner across local and outside sites (time frame: From the start to end of patient recruitment (2 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07590141, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.