Recruiting

Prehabilitation Comparison

Sponsor:

Jordan Leitch

Code:

NCT07609082

Conditions

Prehabilitation

Preoperative Aerobic Training

Preoperative Care

Exercise Therapy

Postoperative Outcomes

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Multimodal Prehabilitation Program

Educational Materials

Study Details

Brief summary:

The goal of this clinical trial is to learn whether high-dose multimodal prehabilitation, delivered either in person or remotely with coaching and web application support, is feasible and acceptable for women preparing for primary surgery for suspected gynecologic malignancy. It will also examine which delivery model patients prefer and the factors influencing patient preferences.

The main questions ADAPT aims to answer are:

1. Can participants achieve the prescribed aerobic exercise target of at least 10 MET-hours per week before surgery?
2. Do patients prefer in-person prehabilitation, remote prehabilitation, or education-only care, and what factors influence that preference?

The researchers will compare in-person prehabilitation, remote prehabilitation, and education-only care to see which delivery approach is most feasible, acceptable, and practical for patients with suspected gynecologic cancer.

Participants will:

  • Choose their preferred study group, or be randomly assigned if they have no preference
  • Complete patient-reported questionnaires and semi-structured interviews at baseline, 1-3 days before surgery, and 4 weeks after surgery
  • If assigned to a prehabilitation group, complete aerobic exercise, protein supplementation, and daily breathing exercises before surgery
  • Attend weekly coaching sessions with a trained prehabilitation coach
  • Use the KingstonPrehab web application to track exercise, nutrition, breathing practice, and progress toward activity goals

Conditions

Prehabilitation

Preoperative Aerobic Training

Preoperative Care

Exercise Therapy

Postoperative Outcomes

Study ID

NCT07609082

Start date

May 14, 2027

Status verified date

May, 2026

Completion date

May 14, 2027

Anticipated

Primary completion date

May 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Female
  • Aged ≥18 years
  • Scheduled for cytoreductive surgery for a gynecologic mass suspected or confirmed of cancer
  • Surgery planned ≥3 weeks from time of booking
  • No contraindications to exercise on the CSEP Get Active Questionnaire
  • Able to provide written informed consent
  • Able to understand and communicate in English

Exclusion Criteria:

  • Pregnancy
  • Cervical pathologies
  • Surgery scheduled <3 weeks from booking
  • Receiving neoadjuvant chemotherapy
  • Positive contraindications to exercise on the CSEP Get Active Questionnaire
  • End-stage or advanced renal disease limiting safe protein supplementation
  • Malnutrition as assessed by a registered dietician

Study Design

Enrollment

36 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: In-Person Prehabilitation

Participants will complete a multimodal prehabilitation program delivered in-person at the School of Kinesiology and Health Studies. The intervention consists of supervised aerobic exercise (≥10 MET-hours/week above baseline), daily protein supplementation, daily box breathing, weekly one-on-one behavioural coaching, use of the KingstonPrehab web application, and standardized educational materials.

experimental: Remote Prehabilitation

Participants will complete the same multimodal prehabilitation program as the in-person arm, but remotely at home or in community facilities. The intervention consists of independent aerobic exercise (≥10 MET-hours/week above baseline), daily protein supplementation, daily box breathing, weekly virtual one-on-one behavioural coaching, use of the KingstonPrehab web application, and standardized educational materials.

active comparator: Education Only

Participants will receive standardized educational materials describing prehabilitation, including aerobic exercise, resistance training, nutrition, and stress management strategies. They will continue with usual preoperative care provided by their healthcare team and will not receive coaching sessions, protein supplementation, or access to the KingstonPrehab web application.

Interventions

Multimodal Prehabilitation Program

The multimodal prehabilitation program consists of progressive aerobic exercise targeting at least 10 MET-hours/week above baseline via 3-5 sessions per week, daily protein supplementation (BOOST Carb Smart; Nestlé Canada Inc.; North York, Ontario, Canada), daily box breathing for stress management, weekly one-on-one behavioural coaching sessions with a trained prehabilitation coach, and use of the KingstonPrehab web application for self-monitoring and progress tracking. Aerobic exercise sessions will be supervised on site. This intervention is delivered either in-person or remotely depending on study arm allocation.

Educational Materials

Participants receive standardized educational materials describing the principles of prehabilitation, including aerobic exercise, resistance exercise, nutrition focusing on perioperative protein intake, and stress management strategies. Participants will also receive a postoperative recovery handbook adapted from the Montreal General Hospital Prehabilitation Clinic that provides guidance on nutrition, pain and constipation management, mobilization, in-hospital exercise, and a progressive return-to-activity plan for the first 8 weeks after surgery.

Primary outcome measure

  • Behavioural adherence to exercise target (≥10 MET-hours/week) [ Time Frame: Enrolment to preoperative assessment (3-6 weeks) ]
  • Patient preference for delivery model [ Time Frame: Quantitative: Enrolment to preoperative assessment (3-6 weeks). Qualitative: baseline and 4-week postoperative interviews. ]

Central Contacts and Locations

Central contacts

Deborah DuMerton

613-484-7322deborah.dumerton@kingstonhsc.ca

Rachel Phelan

613-548-7827rachel.phalen@kingstonhsc.ca

Locations

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Deborah DuMerton

613-484-7322deborah.dumerton@kingstonhsc.ca

Rachel Phelan

613-548-7827rachel.phalen@kingstonhsc.ca

Principal Investigator:

Jordan Leitch, MSc, MD, FRCPC

More Information

Sponsor

Jordan Leitch

Last update posted

Oct 30, 2026

Last verified

May, 2026

Keywords

  • postoperative outcomes
  • prehabilitation
  • nutritional support
  • psychological support
  • exercise therapy
  • gynecologic cancers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-31. This information was provided to ClinicalTrials.gov by Jordan Leitch on 2026-10-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.