Prehabilitation Before Major Surgery

NCT07590141 | Not Yet Recruiting DMC

• 1 other identifier: PRIME Pilot
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief 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:

• 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

Conditions

Prehabilitation; Preoperative Care; Elective Surgical Procedures; Surgical Procedures, Operative; Postoperative Complications

Keywords

Home-based Care; Virtual Care; Remote Health Monitoring; Exercise Therapy; Nutritional Support; Psychological Support; Postoperative Outcomes

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From enrolment to the day of scheduled surgery (3 week timespan)

Secondary Outcomes (14)

• Postoperative complications

  30 days post-surgery

• Mortality

  30 days post-surgery

• Disability

  30 days post-surgery

• Length of stay and readmission

  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 at each major assessment point throughout the study. (1) Baseline - Day 0 (2) 2 days prior to surgery (3) 30 days after surgery

Study Arms (2)

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.

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.

Interventions

Virtually Monitored Home-Based Prehabilitation Program BEHAVIORAL

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.

Prehabilitation Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University: lead
• Canadian Anesthesia Research Foundation: collaborator
• Ottawa Hospital Research Institute: collaborator
• Kingston Health Sciences Centre: collaborator
• Hamilton Health Sciences Centre: collaborator
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (3)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

The Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

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MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jordan Leitch, MSc, MD, FRCPC

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah DuMerton

CONTACT

613-484-7322; Deborah.DuMerton@Kingstonhsc.ca

Rachel Phelan

CONTACT

613-548-7827; Rachel.Phalen@Kingstonhsc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research staff (with the exception of the individual informing participants of group allocation), healthcare providers, and outcome assessors will be blinded to treatment allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PGME Program Director and Assistant Professor - Department of Anesthesiology and Perioperative Medicine

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: May 15, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

CA (3)