Recruiting

Prehabilitation

Sponsor:

Jordan Leitch

Code:

NCT05880992

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise

Nutrition

Mindfulness

Study Details

Brief summary:

The goal of this clinical pilot is to determine the feasibility of implementing trimodal prehabilitation within the current perioperative infrastructure in patients having major colorectal surgery for resection of a cancer (CRC). Trimodal prehabilitation includes exercise, nutrition and mindfulness coaching and support which has been shown to improve physical status, mental preparation and to reduce loss of lean body mass in CRC patients. The primary questions this study aims to answer are: Is delivery of trimodal prehabilitation feasible within our current perioperative infrastructure and does prehabilitation impact outcomes in these patients? Researchers will compare this newly recruited prehabilitation cohort to a historical cohort of patients who did not receive prehabilitation in terms of mortality, length of stay, complications, readmissions, emergency department visits and non-home discharge.

Conditions

Colorectal Cancer

Study ID

NCT05880992

Start date

Jul 24, 2023

Status verified date

Jun, 2024

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • age 18 or older
  • major colorectal surgery (colectomy, low anterior resection or abdominoperineal resection)

Exclusion Criteria:

  • refusal to participate in study
  • inability to understand questionnaires and participate in psychological assessments in English

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Progress Check

This arm will include pre- and post-prehabilitation questionnaires as well as twice weekly progress checks by the research assistant to check on participant progress, answer questions and provide accountability and motivation.

other: No Progress Check

This arm will include only pre- and post-prehabilitation questionnaires.

Interventions

Exercise

Aerobic and Strength exercises (equipment free, simple, modifiable)

Nutrition

Counselling on daily protein target of 1.2 g/kg as well as supplementation with protein shake (provided)

Mindfulness

Deep (box) breathing completing in the morning, evening and as needed.

Primary outcome measure

  • Retention rate [ Time Frame: Four to six weeks prior to surgery ]
  • Recruitment rate [ Time Frame: Four to six weeks prior to surgery ]
  • Exercise completion rate [ Time Frame: Four to six weeks prior to surgery ]
  • Nutrition compliance rate [ Time Frame: Four to six weeks prior to surgery ]
  • Mindfulness compliance rate [ Time Frame: Four to six weeks prior to surgery ]
  • Adherence rate [ Time Frame: Four to six weeks prior to surgery ]

Central Contacts and Locations

Central contacts

Jordan Leitch, MD

6134494223Jordan.Leitch@Kingstonhsc.ca

Locations

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K0H1S0

Contacts

Jordan Leitch

6134494223jordleitch@hotmail.com

More Information

Sponsor

Jordan Leitch

Last update posted

Jun 21, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jordan Leitch on 2024-06-21.