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The Challenges of Evidence-based Prehabilitation in a Real-life Context for Patients Preparing for Colorectal Surgery

NCT06438484 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2024-06-03

No results posted yet for this study

Summary

Background: Multimodal prehabilitation programs are effective in reducing complications after colorectal surgery in patients with high risk of postoperative complications due to low aerobic capacity and/or malnutrition. However, high implementation fidelity is needed to achieve these effects in real-life practice. Therefore, this study aimed to investigate the implementation fidelity of an evidence-based prehabilitation program in the real-life context of a regional hospital.

Methods: In this observational cohort study with multiple case analysis, we enrolled all patients who underwent surgery for colorectal cancer from January 2023 to June 2023, in one Dutch peripheral hospital. Patients meeting criteria for low aerobic capacity or malnutrition were advised to participate in a personalized prehabilitation program. Implementation fidelity was investigated on four domains; 1) coverage (participation rate), 2) duration (number of days following the prehabilitation program), 3) content (delivery of prescribed intervention modalities), and 4) frequency (attendance of sessions and compliance with prescribed parameters). An aggregated percentage of content and frequency was calculated to determine overall adherence. The intended outcomes were improvement in preoperative aerobic capacity and malnutrition, and improved postoperative recovery (i.e., reducing complications, length of stay, and time to functional recovery).

Conditions

  • Colorectal Surgery

Interventions

BEHAVIORAL

multimodal prehabilitation program

Patients performed physical exercise training and/or received dietary counseling for five weeks, provided by a trained physiotherapist and dietitian (both \>15 years experience). The physical exercise training consisted of high-intensity interval training (HIIT) three times a week and functional strengthening exercises. Patients visited the hospital two times a week and performed home exercise training five times a week on a stationary cycle ergometer (Corival Home+, Lode BV, Groningen, The Netherlands). The dietary intervention consisted of optimization of energy and protein intake, optimization of timing of eating protein-rich products, and if necessary additional protein and vitamin supplements. Individual protein requirements were set at 1.5-1.9 g/kg fat free mass. Patients used the eiFIT-application or a food diary to track their protein intake.

Sponsors & Collaborators

  • Nij Smellinghe Hosptial

    lead OTHER

Principal Investigators

  • Aletta Danielle Talen, drs · Nij Smellinghe

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06438484 on ClinicalTrials.gov