The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: The PROPEL Trial
NCT Number: NCT06565052
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rectal Cancer|Colorectal Cancer|Rectal Cancer Stage II|Rectal Cancer Stage III
Interventions: BEHAVIORAL: Prehabilitation Program
Sponsor: Dana-Farber Cancer Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2025-02
Completion Date: 2027-08-07
Locations: Dana-Farber Cancer Institute, Boston, Massachusetts, 02115, United States|Brigham and Women's Hospital, Boston, Massachusetts, 02215, United States

Summary:
The purpose of this study is to determine the feasibility of a prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant chemotherapy and/or radiation, followed by surgical resection.

The names of the groups in this research study are:

* Group A: Prehabilitation program
* Group B: Usual Care

Primary Outcome Measures: Enrollment Rate, The proportion of eligible individuals that are enrolled to the study. Feasibility of the intervention is defined as an enrollment rate of greater than 10% of approached, eligible participants., Baseline
Secondary Outcome Measures: Adherence Rate to the Prehabilitation Program, The number of intervention assessments completed by participants in Group A. Feasibility of the intervention is defined as at least 50% of participants adhering to at least 50% of the prescribed assessments of the prehabilitation program., At post-intervention (approximately Week 4)|Completion Rate of Physical Function Testing (Group A), Defined as the number of testing assessments (resting blood pressure, measure of cardiorespiratory fitness, Short Physical Performance Battery, muscular strength, and anthropometric measures) completed by participants., At post-intervention (approximately Week 4)|Completion Rate of Physical Function Testing (Group B), Defined as the number of testing assessments (resting blood pressure, measure of cardiorespiratory fitness, Short Physical Performance Battery, muscular strength, and anthropometric measures) completed by participants., At post-intervention (approximately Week 4)|Completion Rate of Questionnaire Assessments, Defined as the number of questionnaires completed by all participants., At baseline and the postoperative visit (approximately Week 9)|Participant Fall Rate (Group A), Defined as the number of falls attributable to the exercise and nutrition components of the intervention., At post-intervention (approximately Week 4)|Participant Fall Rate (Group B), Defined as the number of falls attributable to the exercise and nutrition components of the intervention., At post-intervention (approximately Week 4)|Rate of Hospitalization (Group A), Defined as the number of hospitalizations attributable to the exercise and nutrition components of the intervention., At post-intervention (approximately Week 4)|Rate of Hospitalization (Group B), Defined as the number of hospitalizations attributable to the exercise and nutrition components of the intervention., At post-intervention (approximately Week 4)|Rate of Musculoskeletal Injury (Group A), Defined as the number of musculoskeletal injuries attributable to the exercise and nutrition components of the intervention., At post-intervention (approximately Week 4)|Rate of Musculoskeletal Injury (Group B), Defined as the number of musculoskeletal injuries attributable to the exercise and nutrition components of the intervention., At post-intervention (approximately Week 4)|Change in Resting Blood Pressure from Baseline to Post-Intervention, Assessed by resting blood pressure. The average systolic blood pressure (of two measurements from each arm) will be recorded., From baseline to post-operative visit (approximately week 9)|Change in Cardiorespiratory Fitness from Baseline to Post-Intervention, Assessed by VO2peak by a graded maximal (or submaximal if equipment is unavailable) cycle exercise stress test. VO2peak is defined as the highest values of oxygen uptake averaged among every 30-second interval during the test. VO2peak will be reported in both relative (ml·kg-1·min-1) and absolute (L/min) terms., From baseline to post-operative visit (approximately week 9)|Change in Short Physical Performance Battery (SPPB) Score from Baseline to Post-Intervention, Assessed by the Short Physical Performance Battery (SPPB) which is comprised of three sections: 1) balance with feet together, semi tandem, and full tandem is held for up to 10 seconds with no support and measure in seconds. Scores are summed for the measure of balance for a range of 0 to 30 seconds; 2) usual gait speed over four meters is timed (seconds); and 3) chair stand where the time(s) to complete five chair sit-to-stands is recorded. Each of the three performance measures is assigned a score ranging from 0 to 4, with 4 indicating highest level of performance and 0 indicating inability to complete test. A summary score ranging from 0 (worst performers) to 12 (best performers) is calculated by adding walking speed, chair stands and balance scores., From baseline to post-operative visit (approximately week 9)|Change in Muscle Strength from Baseline to Post-Intervention, The 1RM (repetition maximum) will be estimated from 10RM muscle strength tests on two exercises: 1) leg press, 2) chest press. 1RM values will be calculated and reported using validated equations., From baseline to post-operative visit (approximately week 9)|Change in Height from Baseline to Post-Intervention, Height will be measured using a stadiometer, rounding up to the nearest 0.1 cm, From baseline to post-operative visit (approximately week 9)|Change in Weight from Baseline to Post-Intervention, Assessed by weight, rounding up to the nearest 0.1 kg., From baseline to post-operative visit (approximately week 9)|Change in Waist Circumference from Baseline to Post-Intervention, Waist circumference will be measured, rounding up to the nearest 0.1cm., From baseline to post-operative visit (approximately week 9)|Change in Hip Circumference from Baseline to Post-Intervention, Hip circumference will be measured, rounding up to the nearest 0.1cm., From baseline to post-operative visit (approximately week 9)|Change in Body Mass Index from Baseline to Post-Intervention, Body composition will be assessed via bioelectrical impedance using a validated device. The device will estimate body fat using an algorithm based on participant age, sex, height, and body weight., From baseline to post-operative visit (approximately week 9)|Change in Nutritional Status from Baseline to Post-Surgery (Group A), Assessed by the Perioperative Nutrition Score (PONS), a validated screening questionnaire that assists in determining risk of malnutrition in the perioperative setting. This is assessed via 1) Body mass index (BMI), which can be calculated through the participant's anthropomorphic measurements, 2) self-reported unplanned changes in weight or decrease in dietary intake, or 3) preoperative albumin level., From baseline to postoperative visit, up to 9 weeks|Change in Nutritional Status from Baseline to Post-Surgery (Group B), Assessed by the Perioperative Nutrition Score (PONS), a validated screening questionnaire that assists in determining risk of malnutrition in the perioperative setting. This is assessed via 1) Body mass index (BMI), which can be calculated through the participant's anthropomorphic measurements, 2) self-reported unplanned changes in weight or decrease in dietary intake, or 3) preoperative albumin level., From baseline to postoperative visit, up to 9 weeks|Change in Quality of Life from Baseline to Post-Surgery (Group A), Assessed by the European Organization for Research and Treatment of Cancer's (EORTC's) Quality of Life (QOL) core questionnaire (QLQ C-30), a validated, 30-item instrument designed to quantify and measure QOL in cancer participants. Questions are rated on a four point scale from 1 "Not at all" to 4 "Very much. All items have a score range from 0 to 100 points. A higher score represents better function and a higher quality of life., From baseline to postoperative visit, up to 9 weeks|Change in Quality of Life from Baseline to Post-Surgery (Group B), Assessed by the Pittsburgh Sleep Quality Index (PSQI), a 19 question measure of 7 domains of sleep quality and patterns of sleep. The 19 self-rated items are combined to form 7 component scores, each of which has a range of 0 to 3 points with a 0 indicating no difficulty and 3 indicating severe difficulty. The 7 component scores are added to yield a total score with a range of 0 to 21 points. A total score of 5 or greater is indicative of poor sleep quality., From baseline to postoperative visit, up to 9 weeks|Change in Pittsburgh Sleep Quality Index (PSQI) Score from Baseline to Post-Surgery (Group A), Assessed by the Pittsburgh Sleep Quality Index (PSQI), a 19 question measure of 7 domains of sleep quality and patterns of sleep. The 19 self-rated items are combined to form 7 component scores, each of which has a range of 0 to 3 points with a 0 indicating no difficulty and 3 indicating severe difficulty. The 7 component scores are added to yield a total score with a range of 0 to 21 points. A total score of 5 or greater is indicative of poor sleep quality., From baseline to postoperative visit, up to 9 weeks|Change in PSQI Score from Baseline to Post-Surgery (Group B), Assessed by the Pittsburgh Sleep Quality Index (PSQI), a 19 question measure of 7 domains of sleep quality and patterns of sleep. The 19 self-rated items are combined to form 7 component scores, each of which has a range of 0 to 3 points with a 0 indicating no difficulty and 3 indicating severe difficulty. The 7 component scores are added to yield a total score with a range of 0 to 21 points. A total score of 5 or greater is indicative of poor sleep quality., From baseline to postoperative visit, up to 9 weeks|Change in Clinical Frailty Scale (CFS) Score from Baseline to Post-Surgery (Group A), Assessed by the Clinical Frailty Scale (CFS), which consists of 9 questions assessing specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill)., From baseline to postoperative visit, up to 9 weeks|Change in Clinical Frailty Scale (CFS) Score from Baseline to Post-Surgery (Group B), Assessed by the Clinical Frailty Scale (CFS), which consists of 9 questions assessing specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill)., From baseline to postoperative visit, up to 9 weeks|Length of Hospitalization Post-Surgery (Group A), Defined as the number of days of hospitalization post-surgery., 30 Days|Length of Hospitalization Post-Surgery (Group B), Defined as the number of days of hospitalization post-surgery., 30 Days|Time To Return of Bowel Function Post-Surgery (Group A), Defined as the number of days to a return of bowl function post-surgery., 30 Days|Time To Return of Bowel Function Post-Surgery (Group B), Defined as the number of days to a return of bowl function post-surgery., 30 Days|Discharge Disposition (Group B), Defined as participant disposition post-surgery: discharge to home, inpatient rehabilitation facility, or other. Data will be summarized using descriptive statistics., 30 Days|Discharge Disposition (Group A), Defined as participant disposition post-surgery: discharge to home, inpatient rehabilitation facility, or other. Data will be summarized using descriptive statistics., 30 Days