Recruiting

Prehabilitation

Sponsor:

McGill University

Code:

NCT05999370

Conditions

Prehabilitation

Malnutrition

Physical Functional Performance

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Nutrition

Exercise

Study Details

Brief summary:

Despite multi-modal prehabilitation (nutrition, exercise, and psychosocial interventions), 60% of older elective colorectal cancer surgery patients with poor physical function were unable to reach a minimum preoperative 400m six-minute walking distance (6MWD), a prognostic cut-point. Compared to the patients that attained >400m 6MWD preoperatively, twice as many of <400m patients were malnourished. Malnutrition has long been associated with worse functioning (e.g., physical, immune). The investigators hypothesize that for nutritionally deficient patients, the etiology for their poor physical function is malnutrition. Correction of malnutrition alone might thus be sufficient to achieve a 400m 6MWD before surgery and improve patient outcomes.

Conditions

Prehabilitation

Malnutrition

Physical Functional Performance

Study ID

NCT05999370

Start date

Jan 31, 2022

Status verified date

May, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients aged 65 years and older;
  • Patients with cancer scheduled for primary colorectal resection;
  • Patients with 6MWD at baseline less than 400 m;
  • Patients with Patient-Generated Subjective-Global Assessment (malnutrition assessment) score equal or greater than 9.

Exclusion Criteria:

  • Patients with history of premorbid conditions that contraindicate exercise including dementia, -Parkinson's disease or previous stroke with paresis;
  • Metastatic cancer;
  • Patients who do not speak English or French and cannot be accompanied by someone who speaks English or French;

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Nutrition and exercise

The nutrition intervention will be based on a comprehensive nutrition assessment by a dietitian at baseline, enabling individualized caloric and protein targets.

The exercise intervention will be personalized based on a comprehensive assessment to include both a resistance and an aerobic component in the form of a "snack".

other: Nutrition only

The nutrition intervention will be based on a comprehensive nutrition assessment by a dietitian at baseline, enabling individualized caloric and protein targets.

Interventions

Nutrition

The nutrition intervention will be based on needs assessed by indirect calorimetry, patient-generated subjective global assessment, and 24hr recall conducted at baseline, enabling individualized caloric and protein targets.

Deficits in nutrient intake will be addressed with one-on-one dietary counselling and supplementation at baseline in a quantity that matches the estimated deficit in intake. Adherence will be monitored using 24-hr recalls and weight status by the dietitian weekly.

Exercise

The exercise intervention will include both a resistance and an aerobic component to be performed a total of 5 times a day, 5 times per week, 5 minutes each session, totaling 125 minutes per week. The ability to perform exercises as prescribed will be monitored with a weekly in-person or virtual supervised session.

Primary outcome measure

  • Preoperative six-minute walking distance [ Time Frame: from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in meters ]

Central Contacts and Locations

Central contacts

Chelsia Gillis, RD PhD

514-398-7905chelsia.gillis@mcgill.ca

Natalia Tomborelli Bellafronte, RD PhD

natbella@ymail.com

Locations

MUHC Research Ethics Board

Recruiting

Montréal, Quebec, Canada, H4A 3T2

Contacts

Elizabeth Craven, PhD

514 934-1934reb.ct1@muhc.mcgill.ca

More Information

Sponsor

McGill University

Last update posted

May 9, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University on 2025-05-09.